Join Our Team

Moderna is leading a paradigm shift—making the impossible possible.

Join the revolution as we transform how medicines are developed and diseases are treated through an entirely new in vivo drug modality. We have forged major partnerships, attracted first-rate leadership, and received unprecedented funding to support our breakthrough work and build our team.

Be part of this groundbreaking science. Help propel it forward.

We are seeking extraordinary and ambitious people to join a team of 100 passionate and dedicated colleagues. We value a bright mind, sharp instincts, collaborative spirit, and innovative vision. Our employees are trailblazers who push beyond the status quo to create something new and meaningful to improve people’s lives.

In addition to exceptional career opportunities and the fulfillment of improving patient care, Moderna also offers comprehensive benefits including exemplary medical/dental/vision insurance; employer funded health care reimbursement account; competitive matching 401K and long-term incentive program; three weeks vacation (to start) and company paid holidays; short/long term disability and life insurance; and flexible spending accounts. Employees also enjoy a generous employee referral program; company-provided iPad and iPhone; daily catered lunch; free parking, monthly T pass or subsidized commuter rail pass; and more.

Join us. Submit your resume and cover letter using the button under the corresponding job listing.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.


Current Job Listings

Research & Development

Process Development, Manufacturing & Quality

Regulatory Affairs


Sr / Principal Scientist, Infectious Diseases

Position Summary:

We have an opening for a talented Senior / Principal Scientist Immunologist to join our newly-formed infectious disease team. Able to function in a highly collaborative and fast-paced environment, the successful applicant will support the discovery of infectious disease vaccines via the application and advancement of Moderna’s mRNA technology platform.

Responsibilities:

  • Independently establish experimental protocols and procedures to assess the biology and efficacy of vaccines or other immune-modulatory therapeutic candidates.
  • Manage and prioritize a portfolio of promising infectious disease vaccine candidates and drive individual candidates towards IND application.
  • Conduct research activities, using in vitro, ex-vivo and in vivo models as necessary, with the aim of identifying suitable targets for autoimmune or inflammatory diseases. Translate these ideas into therapeutic approaches via the application of Moderna’s mRNA platform technology.
  • Establish preferred external collaboration and vendor networks.
  • In close collaboration with other members of the group, other departments and/or external collaborators, help determine the PK, safety and efficacy of the chosen therapeutic approach.
  • Be accountable for project success and timely results delivery.

Minimum Qualifications:

  • Post-Doc/PhD in infectious disease immunology/vaccines with 5 years of experience.
  • Experience with conducting a variety of immunoassays in different model systems.
  • Experience with isolating and culturing different primary cells of the immune system and with using FACS for their characterization.
  • Experience with relevant in vivo infectious disease models.

Preferred Qualifications:

  • PhD in infectious disease with 10+ years of experience related to immunology and infectious diseases.
  • Experienced in generating in vivo infectious disease and vaccine models.
  • Key contributor to the discovery and development of therapeutics and/or vaccines in an industrial setting, ideally to the successful completion of an IND application.

Competencies:

  • Excellent documentation and communication skills.
  • Ability to work both independently and as part of a cross-functional team.
  • Comfortable with presenting and speaking in a variety of settings and with coworkers at a variety of levels.
  • Outcome-oriented and attentive to detail with strong analytical and communication skills.
  • Ability to adapt to frequent change.
If you would like to apply for this position, please click the button below.
Attach your resume and cover letter, and include job reference code 2014-163 in the subject line.

Scientist / Sr Scientist, Skin Diseases

Position Summary:

We have an opening for a talented Scientist / Senior Scientist Dermatologist to join our newly-formed Skin & Cosmetics Team. Able to function in a highly collaborative and fast-paced environment, the successful applicant will support the discovery of immune-modulatory therapeutics via the application and advancement of Moderna’s mRNA technology platform.

Responsibilities:

  • Independently establish experimental protocols and procedures to assess the biology and efficacy of dermatology, aesthetics and cosmetics molecular candidates.
  • Conduct research activities, using in vitro, ex-vivo and in vivo models as necessary, with the aim of identifying suitable targets to address aging/aesthetics, inflammatory skin diseases and wound healing. Translate these ideas into therapeutic approaches and products via the application of Moderna’s mRNA platform technology.
  • Establish preferred external collaboration and vendor networks.
  • In close collaboration with other members of the group, other departments and/or external collaborators, help determine the PK, safety and efficacy of the chosen therapeutic approach.
  • Be accountable for project success and timely results delivery.

Minimum Qualifications:

  • MD and/or PhD in dermatology or regenerative medicine with 3 years scientific experience or PhD in other relevant discipline (cell biology, molecular biology) with 5 years of experience related to dermatology.
  • Experience with conducting a variety of immunoassays and functional assays in different model systems.
  • Experience with isolating and culturing different primary cells of the skin and with using IHC for their characterization.

Preferred Qualifications:

  • MD in dermatology with clinical experience.
  • Experience in generating in vivo models for aesthetics or wound healing.
  • Key contributor to the discovery and development of immune-modulatory therapeutics in an industrial setting, ideally to the successful completion of an IND application.

Competencies:

  • Excellent documentation and communication skills.
  • Ability to work both independently and as part of a cross-functional team.
  • Comfortable with presenting and speaking in a variety of settings and with coworkers at a variety of levels.
  • Outcome-oriented and attentive to detail with strong analytical and communication skills.
  • Ability to adapt to frequent change.
If you would like to apply for this position, please click the button below.
Attach your resume and cover letter, and include job reference code 2014-162 in the subject line.

Scientist, DMPK

Position Summary:

We seek an innovative and motivated scientist with hands-on experience with bio-analysis of protein and RNA, to join the newly-formed Drug Metabolism and Pharmacokinetics (DMPK) Team. Able to function in a highly collaborative and fast-paced environment, the successful applicant will support the discovery and development projects via the application and advancement of Moderna’s mRNA technology platform.

Responsibilities:

  • Independently design and execute methodologies, using internal or external resources, for the quantitation of proteins and modified mRNA’s with a particular emphasis on the state of the art technology.
  • Establish relationships with CRO’s for conducting non-GLP or GLP studies.
  • Establish state of the art bio-analytical laboratory for quantitation of proteins and mRNAs.
  • Carry out in vitro assays as necessary to characterize DMPK properties.
  • Accountable for project success and results delivery.
  • Prepare study protocols and reports, as needed.
  • Closely collaborate with other members within the project teams throughout the company.
  • Record and communicate findings in a timely manner.

Minimum Qualifications:

  • PhD with 1 year industry experience (or BS/MS with equivalent experience) in quantitation of biologics, mostly applied to antibodies and mRNAs.
  • Experience with a variety of protein and DNA/RNA biochemistry techniques (e.g. LC/MS/MS, ELISA, RT-PCR etc.).
  • Familiar with drug discovery and development process in DMPK area.

Preferred Qualifications:

  • PhD with 3+ years relevant industry experience (or BS/MS with equivalent experience) in biologics.
  • Expert knowledge of nucleic acids, antibodies, mRNA molecular structure and stability profiles.
  • Strong consideration will be given to those with experience in the evaluation of antibodies and RNAs.

Competencies:

  • Excellent documentation and communication skills.
  • Ability to work independently and as part of a cross-functional team.
  • Outcome-oriented and attentive to detail with strong analytical skills.
  • Ability to adapt to frequent change.
  • Ability to multi-task.
If you would like to apply for this position, please click the button below.
Attach your resume and cover letter, and include job reference code 2014-161 in the subject line.

Research Associate, Nucleic Acid Synthesis (Cloning)

Position Summary:

We are seeking an innovative and motivated scientist, with hands-on experience in high throughput plasmid cloning and sequencing, to join the newly formed nucleic acid synthesis team. Able to function in a highly collaborative and fast-paced environment, the successful applicant will support gene synthesis efforts to advance Moderna’s mRNA technology platform.

Responsibilities:

  • Independently prepare and assess quality control of cloning vectors.
  • Perform high throughput PCR fragment purification.
  • Carry out restriction-mediated cloning and apply new methodologies such as Gibson assembly method for multiple fragment gene assembly.
  • Prepare competent cells and perform bacterial plasmid transformation.
  • Pick and grow cloned bacterial colonies for overnight culture and perform high throughput plasmid extraction using state-of-the-art robotics.
  • Using high throughput format, perform plasmid purification for Sanger sequencing.
  • Accountable for timely project delivery and project success.
  • Collaborate with other members of the synthesis team and broadly with other relevant departments within the company.
  • Record and archive data and provide project updates at regular intervals.

Minimum Qualifications:

  • BS with at least 3 years of industry experience or MS with at least 1 year of industry experience performing high-throughput cloning.
  • Hands on experience using robotics for cloning, colony picking, plasmid extraction and plasmid purification.
  • Experience with a variety of standard molecular biology techniques (e.g. PCR, gel electrophoresis, restriction digestion, cloning vector preparation, bacterial transformation and nucleic acid purification).
  • Excellent interpersonal and collaborative skills, and the ability to work independently and effectively in a highly dynamic environment.

Preferred Qualifications:

  • Experience with high throughput robotic workstations.
  • Familiarity with nucleic acid therapeutics.
  • Ability to multi-task to meet technology development and research goals.
  • Understanding of database systems and administration concepts.

Competencies:

  • Effectively prioritize work.
  • Ability to execute in a fast pace environment.
  • Teamwork.
  • Learning agility.
  • Effective communication (clear verbal and written communication).
If you would like to apply for this position, please click the button below.
Attach your resume and cover letter, and include job reference code 2014-158 in the subject line.

Research Associate, Nucleic Acid Synthesis (Molecular Biology/Gene Assembly)

Position Summary:

We seek a talented and motivated molecular biologist with hands-on experience in PCR-based gene assembly to join the newly formed nucleic acid synthesis team. The main responsibility of this candidate will be to chemically synthesize genes from oligonucleotides using PCR-based assembly method using cutting edge robotics and automation. We are looking for a high-energy candidate with the ability to excel in a high throughput gene assembly environment.

Responsibilities:

  • Independently prepare and assess quality control of cloning vectors.
  • Perform high throughput PCR fragment purification.
  • Carry out restriction-mediated cloning and apply new methodologies such as Gibson assembly method for multiple fragment gene assembly.
  • Prepare competent cells and perform bacterial plasmid transformation.
  • Pick and grow cloned bacterial colonies for overnight culture and perform high throughput plasmid extraction using state-of-the-art robotics.
  • Using high throughput format, perform plasmid purification for Sanger sequencing.
  • Accountable for timely project delivery and project success.
  • Collaborate with other members of the synthesis team and broadly with other relevant departments within the company.
  • Record and archive data and provide project updates at regular intervals.

Minimum Qualifications:

  • BS with at least 3 years of industry experience or MS with at least 1 year of industry experience performing high-throughput molecular biology work.
  • Hands on experience operating pick-and-place robots and automated workstations.
  • Experience with a variety of standard molecular biology techniques (e.g. PCR, gel electrophoresis, and nucleic acid purification).

Preferred Qualifications:

  • Experience with high throughput robotic workstations.
  • Attention to detail and ability to problem solve required.
  • Ability to multi-task to meet technology development and research goals.

Competencies:

  • Effectively prioritize work.
  • Ability to execute in a fast pace environment.
  • Teamwork.
  • Learning agility.
  • Effective communication (clear verbal and written communication).
If you would like to apply for this position, please click the button below.
Attach your resume and cover letter, and include job reference code 2014-157 in the subject line.

Associate Director, Project Management

Position Summary:

Reporting to the R&D Chief of Staff and Head of Program Management, the Associate Director, Project Management is responsible for coordination of cross-functional teams and relationship management across research and development programs. The position will serve as the primary manager for coordination of interactions between Moderna research and development groups and other internal groups, including manufacturing and business groups. Working in a dynamic, highly collaborative and fast paced environment, the Associate Director, Project Management will function to balance the strategic needs of the R&D programs with tactical day-to-day activities while fostering open communication and cooperation with internal and external stakeholders at all organizational levels.

Responsibilities:

  • Work closely with the R&D Head of Program Management, R&D Chief of Staff, R&D Senior Leaders and cross-functional project leaders to help define program and project goals as well as operational management of milestone delivery and services.
  • Work as key R&D liason for R&D outsourcing efforts including vendor due diligence and contract negotiation.
  • Organize, communicate and maintain detailed program milestones, budget and timelines.
  • Ensure clear communication of program priorities to enable timely delivery of project goals, identify and help resolve issues.
  • Facilitate communication and planning to identify and coordinate key strategic and operational interdependencies, drive decision-making, issue resolution and execution across R&D as well as keeping all stakeholders up to date regarding program and project progress.
  • Clear understanding of molecular biology, familiarity with intellectual property issues and other scientific issues associated with mRNA therapeutics, detailed comprehension of program activities sufficient to anticipate potential program operational issues.
  • Apply project management best practices, including development of timelines and budgets, development of agendas, streamlined and efficient meeting management, distribution of meeting summaries, and efficient follow up of all relevant action items.
  • Proactively identify opportunities for improvement to optimize team effectiveness and outcomes.
  • Balance conflicting priorities across multiple objectives or programs, and articulate risks and trade-offs.
  • Coordinate management review of program progress to plan financial and performance metric reporting, external CRO relationship and collaboration.

Minimum Qualifications:

  • BS/MS in life science, medical, or related field and 4 years project management experience in the biopharmaceutical industry.
  • Ability to quickly understand the science underlying generation of mRNA therapeutics.
  • Ability to quickly understand the operational and strategic business issues associated with small biotechnology organizations.
  • Exposure to early-stage research programs through Phase I/II proof-of-concept clinical studies is essential.
  • Outstanding project management, resource planning, and organization skills.

Preferred Qualifications:

  • Clear understanding and experience with research and drug development processes strongly preferred.
  • Experience with CRO interactions including identification, due dilegence and contract negotiation a strong plus.
  • Experience with science industry/academic collaborations a strong plus.

Competencies:

  • Common sense.
  • Professional demeanor.
  • Outstanding communication (oral & written).
  • Team orientation.
  • Results orientation.
  • Detail orientation.
  • Highly organized.
  • Negotiate conflict situations, forging alignment.
  • Personal commitment to overarching vision to improve lives of patients in need.
If you would like to apply for this position, please click the button below.
Attach your resume and cover letter, and include job reference code 2014-156 in the subject line.

Research Associate / Sr Research Associate, Molecular and Cellular Technologies

Position Summary:

We seek a talented and motivated in vitro biologist to assist in developing the data package to support advancement of Moderna’s mRNA technology platform and pipeline by rapidly screening the activity of modified mRNA using a variety of in vitro and cell-based assays.

Responsibilities:

  • Performance of high throughput in vitro assays (ELISA, FACS, Luminex, luminescent and fluorescent reporter systems, Western blotting, cellular uptake, serum and cellular stability, etc.) using cultured and primary mammalian cells.
  • Standard mammalian cell culture support including maintaining and plating of cell lines.
  • General laboratory assistance including laboratory equipment maintenance, preparation of reagents, and the ordering and receiving of laboratory supplies.
  • Accountable for project success and results delivery.
  • Closely collaborate with other members within the research group and broadly with departments throughout the company.
  • Record and communicate findings.

Minimum Qualifications:

  • BS with at least 5 years of industry experience or MS with at least 3 years of industry experience developing and performing ELISA, FACS, luminescent and fluorescent based in vitro cell-based screening assays.
  • Hands on experience with mammalian cell culture and the utilization of cell-based assays to examine the expression and activity of a variety of protein targets.
  • Excellent interpersonal and collaborative skills, and the ability to work independently and effectively in a highly dynamic environment.

Preferred Qualifications:

  • Experience with high throughput screening using robotic workstations.
  • Familiarity with nucleic acid therapeutics.
  • Ability to multi-task to meet technology development and research goals.

Competencies:

  • Attention to detail.
  • Independence.
  • Teamwork.
  • Effective communication (oral and written).
  • Ability to adapt to frequent change.
If you would like to apply for this position, please click the button below.
Attach your resume and cover letter, and include job reference code 2014-150 in the subject line.

Scientist / Senior Scientist, Antibody Engineer

Position Summary:

We are seeking an innovative and motivated scientist with hands-on experience of antibody engineering, to join the newly-formed Immunology and Biotherapeutics Team. Able to function in a highly collaborative and fast-paced environment, the successful applicant will support the discovery of immune-modulatory therapeutics via the application and advancement of Moderna’s mRNA technology platform.

Responsibilities:

  • Independently establish experimental protocols and procedures for the design and generation of antibody molecules or other immune-regulatory proteins in a variety of scaffolds.
  • Develop and conduct immunoassays in a variety of formats.
  • Use SPR technology (Octet or Biacore) to determine binding affinities of antibodies.
  • Establish preferred external collaboration and vendor networks.
  • Accountable for project success and results delivery.
  • In close collaboration with other members of the group, other departments or external collaborators, help determine the PK, safety and efficacy of the expressed protein.
  • Record and communicate findings in a timely manner.

Minimum Qualifications:

  • PhD in antibody/protein engineering with 2 years of experience or PhD in other relevant discipline (immunology, biochemistry, biology, molecular biology) with 5 years of experience of antibody/protein engineering.
  • Experienced with the use of Octet or Biacore to determine antibody affinities.
  • Experienced with conducting a variety of immunoassays.
  • Track record of generating antibody/proteins with therapeutic potential.

Preferred Qualifications:

  • PhD in antibody engineering with 5+ years of experience in antibody engineering in an industrial setting.
  • Experienced in phage or other display technology.
  • Experience with engineering single-chain antibody scaffolds.
  • Key contributor to the discovery and development of biotherapeutic candidates, ideally to successful completion of an IND application.

Competencies:

  • Excellent documentation and communication skills.
  • Ability to work both independently and as part of a cross-functional team.
  • Comfortable with presenting and speaking in a variety of settings and with coworkers at a variety of levels.
  • Outcome-oriented and attentive to details with strong analytical and communication skills.
  • Ability to adapt to frequent change.
If you would like to apply for this position, please click the button below.
Attach your resume and cover letter, and include job reference code 2014-144 in the subject line.

Scientist / Senior Scientist, Immunologist

Position Summary:

We have an opening for a talented Scientist / Senior Scientist Immunologist to join our newly-formed Immunology and Biotherapeutics Team. Able to function in a highly collaborative and fast-paced environment, the successful applicant will support the discovery of immune-modulatory therapeutics via the application and advancement of Moderna’s mRNA technology platform.

Responsibilities:

  • Independently establish experimental protocols and procedures to assess the biology and efficacy of antibody or other immune-modulatory therapeutic candidates.
  • Conduct research activities, using in vitro, ex-vivo and in vivo models as necessary, with the aim of identifying suitable targets for autoimmune or inflammatory diseases. Translate these ideas into therapeutic approaches via the application of Moderna’s mRNA platform technology.
  • Establish preferred external collaboration and vendor networks.
  • In close collaboration with other members of the group, other departments and/or external collaborators, help determine the PK, safety and efficacy of the chosen therapeutic approach.
  • Be accountable for project success and timely results delivery.

Minimum Qualifications:

  • PhD in immunology with 2 years of experience or PhD in other relevant discipline (cell biology, molecular biology) with 5 years of experience related to immunology.
  • Experienced with conducting a variety of immunoassays in different model systems.
  • Experience with isolating and culturing different primary cells of the immune system and with using FACS for their characterization.

Preferred Qualifications:

  • PhD in immunology with 10+ years of experience related to immunology.
  • Experienced in generating in vivo models of inflammation or autoimmunity.
  • Key contributor to the discovery and development of immune-modulatory therapeutics in an industrial setting, ideally to the successful completion of an IND application.

Competencies:

  • Excellent documentation and communication skills.
  • Ability to work both independently and as part of a cross-functional team.
  • Comfortable with presenting and speaking in a variety of settings and with coworkers at a variety of levels.
  • Outcome-oriented and attentive to details with strong analytical and communication skills.
  • Ability to adapt to frequent change.
If you would like to apply for this position, please click the button below.
Attach your resume and cover letter, and include job reference code 2014-143 in the subject line.

Director / Sr Director, Formulation Design

Position Summary:

Moderna is seeking a leader in formulations and delivery technologies, responsible for mRNA formulation design and ultimate translation of innovative formulations to clinical development. The individual in this role will lead development and characterization of formulations for in vivo delivery of mRNA based on a broad set of approaches and technologies. He/she will balance internal design effort with initiatives to identify, organize and engage in external collaborations based on current and emerging needs. Broad knowledge of nucleic acid formulations, drug delivery, sterile products manufacture and general pharmaceutical product development is required. The successful candidate must have proven ability to meet technology development and research goals on aggressive timelines while having a record of collaboration with quality units and regulatory stakeholders. Experience in translating pre-clinical formulation work, toxicology and clinical feedback into robust dosage form candidates for regulatory submission is essential, and knowledge of cGMP and other relevant regulation is required. This position has significant visibility and potential for growth in a dynamic organization.

Responsibilities:

  • Lead design and development of nucleic acid formulations for delivery of mRNA.
  • Organize characterization efforts for formulation efforts.
  • Identify, manage and contribute to external formulation collaborations.
  • Management of scientists internally and externally.
  • Maintain accountability for project success and results delivery.
  • Interact closely with internal R&D groups and partners in conducting efficacy and formulation evaluation/PK/Tox studies.
  • Contribute to scientific and strategy discussions to advance and enhance platforms and product candidates – for Moderna and partners.
  • Communicate research and development findings internally and externally.

Minimum Qualifications:

  • Ph.D. with 10 years of industry experience in formulation design and development.
  • Strong foundation in chemistry, materials science, or chemical engineering.
  • A track record of achievement in products, patents and publications.
  • Proven ability to define, manage and maintain scientific business relationships and contract research agreements.
  • Exceptional written and oral communication.

Preferred Qualifications:

  • Experience formulating nucleic acids for in vivo delivery, and deep understanding of polyelectrolyte systems and polymer science.
  • Awareness and understanding of adjacent areas such as the nano-technology space for drug delivery and biologics.
  • A record of building and motivating teams that collaborate effectively; an ability to inspire, mentor and develop staff across the R&D organization.

Competencies:

  • Commitment to excellence and innovation.
  • Flexibility / adaptability to frequent change.
  • Results orientation, ability to manage performance.
  • Effective communication.
  • Personal and shared accountability.
  • Talent development.
If you would like to apply for this position, please click the button below.
Attach your resume and cover letter, and include job reference code 2014-141 in the subject line.

Research Fellow, Pharmaceutical Chemistry (Preformulations)

Position Summary:

This scientific leadership role within formulations and delivery technologies, which reports to the area SVP, will be responsible for mRNA pharmaceutical, physical and chemical characterization efforts in a dynamic and highly interdisciplinary environment. Macrostructural analysis of material characteristics of mRNAs and ultimate translation to formulation are key goals for this position. The individual will balance internal efforts with external initiatives to identify, organize and carry out collaborations based on emerging needs. Passion and ability to contribute to product design efforts through the lens of materials engineering are necessary requirements. A breadth of knowledge of materials science, nucleic acid and protein structure, nanotechnologies for formulation design, drug delivery, sterile products manufacture and general pharmaceutical product R&D is required. The successful candidate must have a strong foundation in organic chemistry and materials science with emphasis on polymer structure and dynamics. He/she should have a proven record of achieving technology development and research goals on aggressive timelines through effective collaborations. Experience integrating molecular design, preformulation characterization, pre-clinical formulation design, toxicology and clinical feedback into robust dosage form candidates in a cross-functional setting is essential.

Responsibilities:

  • Characterize mRNA and materials needed for formulations of mRNAs using physical and chemical techniques.
  • Organize characterization efforts to support formulation design, prepare incisive reports on findings and communicate in various settings.
  • Interact closely with internal R&D groups in conducting formulation evaluations in PK/PD/Tox studies.
  • Identify, manage and contribute to external formulation collaborations.
  • Manage scientific talent internally and externally.
  • Maintain accountability for project success and results delivery.
  • Contribute to scientific and strategy discussions to advance and enhance platforms and product candidates.
  • Communicate research and development findings internally and externally.

Minimum Qualifications:

  • Ph.D. with 10+ years of industry experience in preformulation and pre-clinical formulations including polymer and lipid-based systems.
  • Pharmaceutical characterization expertise and experience from industry, using a structural and mechanistic approach.
  • Strong foundation in chemistry, materials science, chemical engineering or related field.
  • Knowledge of nucleic acids, mRNA molecular structure and stability profiles.

Preferred Qualifications:

  • A track record of achievement in products, patents and publications.
  • Ability to manage and maintain scientific business relationships and contract research agreements.
  • Strong written and oral communication skills, and comfort and effectiveness with senior management interactions.
  • Positive team building and teamwork skills: Innate ability to engage and inspire people, within function and beyond functional/company boundaries.

Competencies:

  • Commitment to excellence and innovation.
  • Flexibility / adaptability to frequent change.
  • Results orientation, ability to manage performance.
  • Effective communication, both written and verbal.
  • Personal and shared accountability.
  • People leadership skills.
If you would like to apply for this position, please click the button below.
Attach your resume and cover letter, and include job reference code 2014-140 in the subject line.

Research Associate / Sr Research Associate, mRNA Synthesis

Position Summary:

Applicants should have exceptional time management skills and pay strong attention to detail. Applicants should have the ability to resolve scientific problems independently with standard protocols. Previous experience with protein and nucleic acids and, specifically, mRNA is required. The main responsibility of this person will be to synthesize chemically modified messenger RNA for optimized drug-like properties. We are looking for a high-energy candidate with ability to adapt to demands of high performance and form a very good collaborative environment with colleagues.

Responsibilities:

  • Manufacturing engineered mRNA molecules.
  • Performing standard molecular biology techniques like PCR, cloning, nucleic acid isolation.
  • Western blotting, immuno-precipitation and ELISA.
  • General laboratory assistance including lab equipment troubleshooting and the ordering and receiving of lab supplies.

Minimum Qualifications:

  • Fresh grad with a BS or MS in Biology with expertise in molecular biology and biochemical techniques.

Preferred Qualifications:

  • BS or MS in Biology and 3+ years of experience in molecular biology and biochemical techniques.
  • Attention to detail and ability to problem solve required.
  • Exceptional data organization.
If you would like to apply for this position, please click the button below.
Attach your resume and cover letter, and include job reference code 2014-139 in the subject line.

Senior Scientist, Proteomics Group Leader

Position Summary:

We seek a highly skilled and motivated senior scientist who is passionate about exploring the potential of mRNA-based therapeutics. The incumbent will establish a state of the art proteomics laboratory with the goal of characterizing protein-mRNA interactions as well as the protein products encoded by Moderna’s mRNA platform. The Proteomics Group Leader and staff will work with other Moderna scientists and external scientific groups to expand the fundamental understanding of the impact of exogenous mRNA-directed therapeutic protein generation on disease biology.

Responsibilities:

  • Establish state of the art proteomics laboratory.
  • Establish proteomics-based strategy and methodologies for characterization of exogenously delivered modified mRNA-cellular protein interactions.
  • Establish proteomics-based strategy and methodologies for characterization of modified mRNA encoded proteins.
  • Hire and supervise proteomics scientific staff members.

Minimum Qualifications:

  • Ph.D. in chemistry, biochemistry, cell biology or a related discipline (background flexible), involving extensive experience with mass spectrometry with 5 years of postdoctoral/industrial experience.
  • Ability to manage, maintain, and employ Orbitrap-based mass spectrometry platforms, as well as experience in HPLC/Auto-sampler utilization.
  • Experience with computational tools for protein identification, statistical analysis and visualization/interpretation of mass spectrometric data.
  • Proven experience with LC-MS analysis of biological samples, including design, conduct and interpretation of experimental analysis of proteins and/or protein complexes.
  • Knowledge of affinity purification techniques for isolation of biomolecules; experience in handling mammalian cells.
  • Familiarity with chemical, biochemical and biological data.
  • Willingness to engage and ability to coordinate multiple collaborative projects in a cross-functional team environment.
  • Relevant publications in peer-reviewed journals expected in support of candidacy.
  • Experience in quantitative approaches including Multi-reaction monitoring, reference peptide analysis, and SILAC based methods is a plus.

Preferred Qualifications:

  • Ph.D. with at least 8 years of industry experience in in protein sciences.
  • Familiarity with mRNA biology.
  • Ability to multi-task to meet technology development and research goals.

Competencies:

  • Excellent interpersonal and collaborative skills, and the ability to work independently and effectively in a highly dynamic environment.
  • Self-motivated, with excellent organizational, oral and written communication skills.
  • Engagement in hands-on bench work.
  • Entrepreneurial spirit.
  • Creative/innovative/problem-solving.
If you would like to apply for this position, please click the button below.
Attach your resume and cover letter, and include job reference code 2013-130 in the subject line.

Scientist / Sr Scientist, mRNA Sciences

Overview:

We are looking for a high-energy candidate with ability to adapt to demands of high performance and form a very good collaborative environment with colleagues in the mRNA engineering group, other R&D groups, and across the company. This job entails directing and performing experiments to advance mRNA therapeutics through engineering of mRNA sequences for optimized drug-like characteristics. Intimate knowledge of mRNA biology and biochemistry, especially transcription and translation is absolutely required. Experience with high throughput DNA/mRNA engineering also required. Ph.D. with 3–5+ years of experience required, industry experience is a plus. Lastly, applicants should have the ability to multi-task and to meet technology development and research goals under aggressive timelines.

Qualifications:

  • Ph.D. with 3–5+ years of experience in mRNA biology and biochemistry, especially transcription and translation required
  • Experience with high throughput DNA/mRNA engineering also required
  • Proven ability to think creatively about molecular design
  • Industry experience a plus
  • Ability to manage and maintain scientific business relationships and contract research agreements
  • Strong written and oral communication skills
  • Positive team building and teamwork skills
  • Strong track record of publications required

Competencies:

  • Teamwork
  • Effective Communication (oral & written)
  • Results Orientation
  • Leadership
If you would like to apply for this position, please click the button below.
Attach your resume and cover letter, and include job reference code 2013-101 in the subject line.

Engineer, Process Development

Position Summary:

This key position is part of Moderna’s dynamic and integrated product development team. As part of this group, the individual will be responsible for driving the development of a robust mRNA drug substance manufacturing process focused on platform-based improvements and process scale-up that will enable and streamline the production of high purity mRNA for pre-clinical supply as well as for cGMP production material.

Responsibilities:

  • Implementing and optimizing processes around cell-free synthesis, purification, and characterization of modified mRNAs.
  • Accelerating novel mRNA drug substance process improvements and ensuring robustness across platform.
  • Establishing pilot scale manufacturing capability and support technology transfer to external CMO for cGMP manufacture.
  • Identifying, evaluating, and deploying new technologies and equipment as part of process scale-up as well as understanding critical process parameters that impact process performance and product quality.
  • Offering technical/troubleshooting support for mRNA manufacturing.
  • Implementing cost reduction measures.
  • Communicating research development findings internally and externally as appropriate.
  • Supporting IND enabling-activities and meeting product development goals under aggressive timelines.

Minimum Qualifications:

  • Biochemical engineering, chemical engineering or biochemistry background with Ph.D. with 2 years of relevant industry experience, MS with 6 years, or BS with 10 years of relevant industry experience.
  • Well versed with a wide array of molecular biology techniques.
  • Experience working and optimizing nucleic acids, enzymatic syntheses, downstream bioprocessing, and performing biophysical characterization is highly desirable.
  • Innovative scientist that possesses ability to think critically and solve problems in laboratory and manufacturing settings.
  • Demonstrated a successful track record delivering against challenging commitments with an evolving data set.

Preferred Qualifications:

  • Biochemical engineering, chemical engineering or biochemistry background with Ph.D. with 5 years of relevant experience, or MS/BS with 15 years of relevant industry experience.
  • Experience optimizing and characterizing in-vitro biochemical processes/enzymatic reactions.
  • Proficiency in preparative chromatography and separations of biomolecules/macromolecules.
  • Excellent leadership and interpersonal skills and capable of being an integrated member of a larger R&D team. S/He should have significant interest and track record in team-based innovation and collaboration.
  • This person should have excellent working knowledge of cGMP and regulatory CMC guidelines.

Competencies:

  • Technical/professional knowledge.
  • Managing work (includes time management).
  • Planning and organization.
  • Work standards.
  • Safety awareness.
  • Applied learning.
  • Innovation.
If you would like to apply for this position, please click the button below.
Attach your resume and cover letter, and include job reference code 2014-164 in the subject line.

Specialist, Document Control

Position Summary:

The Document Control Specialist will be responsible for tracking and trending of documents and establishing and maintaining the company’s document and records control program. You will work closely with production and product testing to update and control information and details, and partner with engineers to establish and test electronic business systems. We seek a candidate with energy, drive and desire to implement processes.

Responsibilities:

  • Document control.
  • Monitor and train completion of records.
  • Test business system implementations.
  • Review of production records and release of product.
  • Generation of COA’s.
  • Monthly metrics tracking.
  • Create templates for documentation, reports, etc.
  • Assist in audits.

Minimum Qualifications:

  • High School or equivalent with >5 year experience.
  • Demonstrated ability to work independently.
  • Demonstrated knowledge of MS Office Suite.

Preferred Qualifications:

  • Bachelor degree with <5 year experience.
  • Working knowledge of Quality Systems.
  • Demonstrated ability to work independently.
  • Demonstrated knowledge of MS Office Suite.

Competencies:

  • Adaptability.
  • Communication.
  • Energy.
  • Follow-up.
  • Gaining commitment.
  • Initiating action.
  • Managing work.
  • Planning and organizing.
  • Quality orientation.
  • Technical / professional knowledge.
If you would like to apply for this position, please click the button below.
Attach your resume and cover letter, and include job reference code 2014-159 in the subject line.

Analyst, Product Testing

Position Summary:

The Product Testing Analyst will perform tests to analyze raw materials, intermediates and final product to correlate to specifications and track-trend the data. The Analyst will work with team members and other departments to establish and maintain the company’s records, communicate with suppliers as well as with customers when needed, and give product/material disposition recommendations.

Responsibilities:

  • Perform calculations and prepare documents for product/material testing and results reporting.
  • Document writing.
  • Test business system implementations.
  • Review of production records and release of product.
  • Generation of COA’s.
  • Monthly metrics tracking.
  • Create templates for documentation, reports, etc.
  • Assist in audits.
  • Other duties may be assigned as needed.

Minimum Qualifications:

  • Associates degree (AA) in chemistry or biochemistry, or technical school training in basic laboratory functions.
  • Demonstrated ability to work independently.
  • Demonstrated knowledge of MS Office Suite.

Preferred Qualifications:

  • Bachelor degree with more than 3 years of experience.
  • Working knowledge of Quality Systems.
  • Demonstrated ability to work independently.
  • Demonstrated knowledge of MS Office Suite.

Competencies:

  • Adaptability.
  • Communication.
  • Energy.
  • Follow-up.
  • Managing work.
  • Planning and organizing.
  • Quality orientation.
  • Technical / professional knowledge.
If you would like to apply for this position, please click the button below.
Attach your resume and cover letter, and include job reference code 2014-155 in the subject line.

Production Team Lead, mRNA Synthesis (2nd Shift)

Position Summary:

As Production Team Lead, you will be expected to mentor a team/staff on processes and protocols, as well as on scientific knowledge of products and material, while ensuring safety of the people, products, equipment and facilities. The Production Lead will need to make fact-based decisions at a moment’s notice to keep production moving. The Lead will work with other teams/departments and communicate with customers when necessary.

Responsibilities:

  • Mentor and verify work of staff members including recommendations, reviews and hiring aspects of team members.
  • Work intimately with Process Development Team to optimize, clarify and document purification procedures for effectiveness, control, traceability, clarity and efficiency while considering impact to cost, quality and quantity.
  • Assist in the development and implementation of QA systems and controlled procedures while owning those pertaining to production processes.
  • Perform production of modified mRNA for in vitro and in vivo experiments, at both small and large scale, using molecular biology techniques to prepare, produce, purify and test DNA and mRNA.
  • Follow and establish protocols, improvements to such, allowing for clear and accurate documentation of data, results, and any deviations.
  • Work in a team environment, in a safe and controlled manner, actively participating in frequent production update meetings and staff meetings.

Minimum Qualifications:

  • BS in biology, biochemistry or molecular biology.
  • Molecular biology experience, including but not limited to nucleic acid purification, PCR, gel electrophoresis, filtrations, column purification, basic laboratory equipment and procedures.
  • Extensive experience with a variety of molecular biology techniques and equipment (such as plasmid linearization, PCR, PCR gradient, Gel and Capillary Electrophoresis bioanalysis of DNA/RNA to check purity, filtration, clean-up and purification systems).

Preferred Qualifications:

  • MS in biology, biochemistry or molecular biology.
  • More than three years experience mentoring, leading or supervising staff.
  • Five year professional/industrial GMP experience in a biotech, diagnostic, therapeutic or pharma company preferred.
  • Process/assay development experience will be useful for data interpretation, presentation and proposing/implementing controlled improvements.

Competencies:

  • Aligning performance for success.
  • Building a successful team.
  • Coaching.
  • Decision making.
  • Delegating responsibility.
  • Developing others.
  • Energy.
  • Facilitating change.
  • Planning and organizing.
  • Safety awareness.
  • Technical / professional knowledge.
If you would like to apply for this position, please click the button below.
Attach your resume and cover letter, and include job reference code 2014-151 in the subject line.

Specialist, Production Planner / Scheduler

Position Summary:

Reporting to the Head of Production, this position will manage the production schedule by working with team leads, communicate schedule to management, prioritize orders, work with suppliers and manage raw materials and finished goods inventory.

Responsibilities:

  • Host weekly meetings gaining knowledge of production status.
  • Communicate expected completion dates to customers.
  • Monitor and ensure timely delivery of raw materials.
  • Coordinate production schedule with product testing schedule.
  • Package and ship products to internal and external customers.
  • Manage finished goods inventory.
  • Test new systems needed to handle 10x growth.
  • Create SOPs and policies for materials management.
  • Generate monthly KPI reports.

Minimum Qualifications:

  • Bachelor’s degree and minimum 3 years of equivalent work experience related to manufacturing operations or scheduling experience.
  • Experience working on cross-functional teams.
  • Experience writing standard operating procedures.
  • Strong written and verbal communication skills.
  • Proven experience in generating routings and bill of materials.

Preferred Qualifications:

  • MBA degree and 5+ years of equivalent work experience related to manufacturing operations or scheduling experience.
  • Experience in GMP environment, therapeutic industry, cloud based ERP systems.

Competencies:

  • Building strategic working relationships.
  • Contributing to team success.
  • Negotiation.
  • Planning and organizing.
  • Quality orientation.
  • Strategic decision making.
If you would like to apply for this position, please click the button below.
Attach your resume and cover letter, and include job reference code 2014-149 in the subject line.

Production Associate, mRNA Synthesis (1st and 2nd Shift)

Position Summary:

The production group is looking for candidates with basic knowledge and experience with molecular biology techniques and adherence to safety and processes.

Responsibilities:

  • Effectively work with Production Team to optimize, clarify and document procedures for effectiveness, control, traceability, clarity and efficiency while considering impact to cost, quality and quantity.
  • Perform production of modified mRNA for in vitro and in vivo experiments, at both small and large scale, using molecular biology techniques, basic and complex scientific equipment and analytical tools.
  • Follow and establish protocols, improvements to such, allowing for clear and accurate documentation of data, results, and any deviations.
  • Work in a team environment, in a safe and controlled manner, actively participating in frequent production update meetings and staff meetings.
  • Manage material inventory for self and team from basic laboratory needs as well as direct production materials.

Minimum Qualifications:

  • BS degree in scientific discipline.
  • Molecular biology laboratory experience, including but not limited to: nucleic acid purification, PCR, gel electrophoresis, column purification, basic laboratory equipment and procedures.

Preferred Qualifications:

  • Knowledge of GLPs and 5S principles.
  • 1-3 years professional/industrial experience in a life sciences or custom gene synthesis company preferred.
  • Experience with controlled business system (inventory control, document management reagent/drug production processes).

Competencies:

  • Effective communication (written and oral).
  • Operates independently.
  • Teamwork / collaboration (ability to work as part of a cross functional team, comfortable with presenting and speaking in a variety of setting and with coworkers at a variety of levels).
  • Results orientation (outcome-oriented).
  • Detail orientation.
  • Multitasking.
If you would like to apply for the first shift of this position, please click the button below. Attach your resume and cover letter, and include job reference code 2014-146 in the subject line.
If you would like to apply for the second shift of this position, please click the button below. Attach your resume and cover letter, and include job reference code 2014-153 in the subject line.

Production Associate, mRNA Synthesis Purification (2nd Shift)

Position Summary:

The production group is looking for an experienced associate-level individual with knowledge and experience with preparative/purification chromatography following GLPs with respect to safety, materials, processes, product, data and records.

Responsibilities:

  • Work intimately with Process Development Team to optimize, clarify and document purification procedures for effectiveness, control, traceability, clarity and efficiency while considering impact to cost, quality and quantity.
  • Assist in the development and implementation of QA systems and controlled procedures while owning those pertaining to production processes.
  • Perform production of modified mRNA for in vitro and in vivo experiments, at both small and large scale, using preparative chromatography procedures to purify mRNA.
  • Follow and establish protocols, improvements to such, allowing for clear and accurate documentation of data, results, and any deviations.
  • Work in a team environment, in a safe and controlled manner, actively participating in frequent production update meetings and staff meetings.

Minimum Qualifications:

  • BS degree in biology, biochemistry or molecular biology.
  • Molecular biology experience, including but not limited to: nucleic acid purification, PCR, gel electrophoresis, column purification, basic laboratory equipment and procedures.
  • Experience with preparative chromatography.

Preferred Qualifications:

  • Five year professional/industrial GMP experience in a biotech, diagnostic, therapeutic or pharma company preferred.
  • Process/assay development experience will be useful for data interpretation, presentation and suggesting/implementing controlled improvements.

Competencies:

  • Excellent documentation and communication skills.
  • Ability to work independently as well as work as part of a cross functional team.
  • Comfortable with presenting and speaking in a variety of settings and with coworkers at a variety of levels.
  • Outcome-oriented and attentive to details with strong analytical and communication skills.
If you would like to apply for this position, please click the button below.
Attach your resume and cover letter, and include job reference code 2014-152 in the subject line.

Research Associate, Drug Product Development

Position Summary:

The primary responsibilities for the Research Associate, Drug Product Development will be to support the Process Development team to develop, characterize, and optimize messenger RNA therapeutics. Knowledge of nucleic acid formulation, delivery, analytical characterization, and development is preferred. The Research Associate will design and conduct experiments to develop mRNA formulations, critically evaluate production process steps, and analyze, interpret, and document experimental results. The Research Associate will work closely with scientists in Process Development to develop mRNA formulations at lab scale and scale-up the process for manufacturing. The position will support cross-functional teams in Research and Development, Production, Quality, and Analytical Development, and the candidate must be able to work in a multi-disciplinary environment.

Responsibilities:

  • Design and conduct experiments to optimize mRNA formulations.
  • Critically evaluate the formulation process and conduct experiments to demonstrate robustness.
  • Support scale-up of drug product manufacturing.
  • Analytical characterization of mRNA and formulations.
  • Analyze, interpret, and document experimental data.
  • Support Process and Analytical Development teams.

Minimum Qualifications:

  • 2 years experience in preformulation and/or formulation development.
  • BS in Chemical Engineering, Chemistry, Biochemical Engineering, Biochemistry or closely related field.

Preferred Qualifications:

  • BS with 2-5 years or MS with 2+ years of industry experience in Oligonucleotide, Pharmaceutical, or Biotechnology development.
  • Experience with nucleic acid formulations.
  • Experience with analytical characterization techniques including, reverse-phase HPLC, SEC, ion exchange HPLC, capillary electrophoresis, differential scanning calorimetry, ultraviolet absorbance spectroscopy, qPCR.
  • Knowledge of nucleic acid chemistry and biology.
  • Knowledge of GMP and GLP regulations.

Competencies:

  • Effective verbal and written communication skills.
  • Detail oriented.
  • Ability to manage multiple projects.
  • Driven to complete assignments.
  • Able to work in a cross-functional, matrix, environment.
If you would like to apply for this position, please click the button below.
Attach your resume and cover letter, and include job reference code 2013-124 in the subject line.

Sr / Principal Research Associate, Process Sciences

Position Summary:

We seek highly skilled and motivated biologists/molecular biologists/biochemists to perform critical research to support advancement of Moderna’s mRNA technology platform. There are two open positions; ideal candidates will have lab experience manipulating DNA and RNA, a creative approach to problem solving and a natural curiosity. These are hands-on roles that offer high visibility and the potential to grow through demonstration of success.

Responsibilities:

  • Design and execute studies using design-of-experiment and other systematic approaches to define process performance with the goal to improve processes.
  • Qualify process improvements and transfer improved processes to production.
  • Support process automation.
  • Troubleshoot issues in production.
  • Closely collaborate with other members within the research and production groups and broadly with departments throughout the company.
  • Record and communicate findings to team and company.

Minimum Qualifications:

  • BS/MS with at least 5 years of industry experience.
  • A strong understanding of molecular biology and mRNA sciences.
  • Demonstrated expertise in molecular biology and associated techniques, preferably with RNA.
  • Experience with analytical techniques such as HPLC, capillary electrophoresis, UV spectrophotometry and ELISA.
  • Excellent interpersonal and collaborative skills, and the ability to work independently and effectively in a highly dynamic environment.

Preferred Qualifications:

  • Experience with nucleic acid therapeutics.
  • Experience in designing and developing novel in vitro assays for specific projects.
  • Advanced techniques in RNA production and manipulation.
  • Understanding of statistical approaches to process development.
  • Ability to multi-task to meet technology development and research goals.

Competencies:

  • Ability to innovate.
  • Problem solving.
  • Excellent documentation and communication skills.
  • Ability to work independently as well as work as part of a cross functional team, comfortable with presenting and speaking in a variety of settings and with coworkers at a variety of levels.
  • Outcome-oriented and attentive to details with strong analytical and communication skills.
  • Ability to adapt to frequent change.
  • Attention to detail.
  • Proactive, forward thinking.
  • Very curious individual with a high energy level.
If you would like to apply for this position, please click the button below.
Attach your resume and cover letter, and include job reference code 2013-127 in the subject line.

Research / Sr Research Associate, Process Development (Drug Substance / Purification)

Position Summary:

The primary responsibilities for the Research / Sr Research Associate, Process Development (Drug Substance / Purification) will be to support the Process Development team to develop and scale-up messenger RNA therapeutics. The Research Associate will develop, scale-up, and optimize processes for mRNA production and purification. In addition, this role will support reaction optimization for mRNA production. With these objectives in mind, each process step must be broken down, analyzed, and critical steps evaluated to enable process improvement and robustness. The position will partner closely with Process Sciences and Production teams, and the candidate must be able to work in a multi-disciplinary environment.

Responsibilities:

  • Develop robust processes for purification of mRNA
  • Develop and evaluate scale-up and scale-down process models
  • Design and conduct experiments to enable process improvements
  • Support process transfers to external collaborators
  • Support cross-functional projects with Process Sciences and Analytical Development teams

Minimum Qualifications:

  • 2 years relevant industry experience
  • BS in Chemical Engineering, Chemistry, Biochemical Engineering, Biochemistry or closely related field

Preferred Qualifications:

  • BS with 2-5 years or MS with 2+ years relevant experience in process development of biomacromolecules (RNA, DNA, proteins)
  • Hands on experience with purification techniques including UF/DF, ion exchange chromatography, affinity chromatography
  • Experience with process scale-up / scale-down
  • Experience with enzymatic reactions is a plus
  • Knowledge of statistical design of experiments (DoE) and analysis
  • Knowledge of nucleic acid chemistry and biology is a plus
  • Knowledge of GMP and GLP regulations

Competencies:

  • Problem solver
  • Effective communication skills
  • Deliver results in a fast-paced environment
  • Collaborative teamwork
If you would like to apply for this position, please click the button below.
Attach your resume and cover letter, and include job reference code 2013-123 in the subject line.

Research Associate, Analytical Development

Position Summary:

The primary responsibilities of the Research Associate, Analytical Development will be to support development of analytical methods for messenger RNA therapeutics and testing support for process development. The Research Associate will develop methods for raw materials, in-process tests, characterization of impurities, and product testing. In addition, the position will support external collaborators and assist with method transfers to / from collaborators as needed. This position will support cross-functional teams in Research and Development, Production, and Quality.

Responsibilities:

  • Support development of analytical methods for raw materials and product release and stability testing
  • Transfer methods to / from external collaborators
  • Support Process Sciences and Process Development teams with testing and product / impurity characterization
  • Provide summary presentations and detailed reports to internal and external stake holders

Minimum Qualifications:

  • BS with 5 years or MS with 3 years relevant industry experience
  • BS/MS in Analytical Chemistry, Biochemistry, Chemical Engineering, or closely related field
  • Analytical method development for HPLC modes (e.g. ion exchange, reverse phase, size exclusion), electrophoretic methods (including bioanalyzer), immunoassays

Preferred Qualifications:

  • Hands on industry experience with analytical development for RNA and DNA therapeutics
  • Knowledge of DNA and RNA sequencing technologies, qPCR methods,
  • Knowledge of nucleic acid chemistry and biology
  • Knowledge of GMP and GLP regulations

Competencies:

  • Effective team player
  • Clear verbal and written communication skills
  • Drive and initiative to deliver on goals in a fast paced environment
  • Efficiency in execution
If you would like to apply for this position, please click the button below.
Attach your resume and cover letter, and include job reference code 2013-126 in the subject line.

Director / Associate Director, CMC Project Management

Position Summary:

The Director / Associate Director, CMC Project Management will work closely with technical and functional area members, vendors, and contract laboratories to develop CMC plan, coordinate and track the progress of CMC plan as established by defined milestones and objectives.

Responsibilities:

  • Work with team leaders to set agendas, plan team strategies, develop CMC plan, coordinate activities and decision making.
  • Coordinate meeting logistics including scheduling the meetings, sending out the agendas, writing and distributing minutes, tracking goals and action items, collecting meeting materials from line functions and distributing them to the team before the meeting.
  • Manage team documentation. Coordinate the collection of CMC material needs, including all cross functional sampling/testing needs for clinical supplies.
  • Identify solutions for project management continuous improvement opportunities across CMC teams and manage execution of the agreed upon strategies.
  • Communicate effectively to stakeholders. Represent the CMC Team when communicating externally.
  • Creates and maintains detailed CMC project plan to ensure clarity of deliverables and timing.
  • Facilitates coordination of deliverables for assigned CMC projects.
  • Tracks project tasks and efforts associated with process development, analytical development, pharmaceutical development, manufacturing, quality, supply chain, and regulatory-CMC.
  • Facilitates assessment of critical path issues and areas of risk, develop risk mitigation plans, and assemble supporting data or 
information to assist in decision making by the project team.
  • Assesses CMC project issues and develops solutions to increase productivity and quality milestones and objectives.
  • Provides support to Management in assessing resource needs to achieve timelines and quality milestones.
  • Works with the team leader to identify and resolve any team and individual performance issues.
  • Identifies and implements best practices in order to facilitate standardization and coordination across disciplines, functions and/or programs.
  • Develops tools and mechanisms for monitoring progress and problem solving with CMC project and functional area managers.
  • Publishes clear and concise meeting agendas, notes and action items.
  • Provides feedback to management of project progress / scope changes / new business opportunities.
  • Cultivates effective communication, cooperation and trust within team members and stakeholders.
  • Develops and maintains a document archiving system for the purpose of efficient communication between stakeholders.

Minimum Qualifications:

  • Degree in a scientific discipline with a minimum of 10 years’ experience in a pharmaceutical or biotechnology environment which includes at least 2 years managing projects in CMC areas for biologics.
  • Demonstrated understanding of the drug development process from research through a commercial product including an understanding of the interdependencies of functional groups.
  • CMC project management experience, PMP certification, advanced degree or MBA a plus.
  • Proficient in relevant software: MS Project, Excel, PowerPoint, Word, etc. in addition to general knowledge with shared work environments. Experience with Visio and Milestones a plus.

Preferred Qualifications:

  • Preferred candidate will have experience in GMP production, process development, scale-up engineering, analytical method development, formulation, and characterization.
  • Demonstrated experience managing interdisciplinary development teams; exceptional skills at facilitating teams and building consensus with membership comprised of diverse levels and areas of the company.
  • Works well independently using strong organizational, project and time management skills.
  • Effective verbal communication skills and excellent written skills. Experience writing scientific, quality and/or regulatory documents highly desirable.

Competencies:

  • Building strategic working relationships.
  • Building trust.
  • Communication.
  • Negotiation.
  • Delegating responsibility.
If you would like to apply for this position, please click the button below.
Attach your resume and cover letter, and include job reference code 2013-134 in the subject line.

Director / Sr Director, Regulatory Affairs, General

Position Summary:

Reporting to the Chief Medical Officer and Head, Regulatory Affairs, this person will actively contribute to the development and implementation of a Regulatory Development strategy for Moderna’s full-length mRNA therapeutic products portfolio and product platform. In addition, the Director/Sr Director, Regulatory Affairs, General, will advise management on Regulatory risk and lead interactions with Regulatory agencies on general and non-GMP CP issues on behalf of Moderna.

Responsibilities:

  • Provide leadership in Moderna’s Regulatory function. Advise Management on Regulatory risk and support project groups in Research and Development with product and development phase-specific advice and risk assessment.
  • Assist with the preparation, review and submission of regulatory documents to relevant regulatory authorities. Identify regulatory experts and consultants and coordinating their interaction with the Company.
  • In collaboration with other members of the Research and Development management team, contribute to the design of preclinical Pharmacology and Safety/Toxicology programs to ensure that they are appropriate and compliant with Regulatory Guidelines and industry practice.
  • Maintain well-organized and appropriate regulatory files, and provide a monthly Regulatory Intelligence report to ensure the Company is informed of evolving guidelines, rulings and practice in the major regulatory regions.
  • Work with the Head of Regulatory Affairs to define Regulatory strategy for Moderna’s product platform and portfolio.
  • Contribute Regulatory input to relevant project teams in Research and Development.
  • Prepare, review and approve, as required, Regulatory documents for submission.
  • Provide project plans and timelines for regulatory submission activities.
  • Coordinate with Research and Development teams to ensure successful Regulatory submission.
  • Lead communication with FDA and international agencies.

Minimum Qualifications:

  • Minimum 15 years industry experience
  • Minimum 5 years in a senior Regulatory Leadership role
  • Must have a BS in a scientific discipline
  • Track record of successful global filings
  • Able to provide regulatory leadership on a cross-functional team and work effectively in a matrix environment
  • Capable of strategic thinking and proposing innovative solutions to regulatory problems
  • Advanced knowledge and experience in interpretation of regulations, guidelines and precedents related to drug development
  • Success working on multiple programs
  • Demonstrates excellent communication skills with ability to impact and influence the decisions of a team
  • Communicate effectively in verbal presentations and in writing regulatory strategy plans and submission documents and act as a liaison/representative both internally and externally
  • Ability to inspire and motivate others to pursue professional excellence

Preferred Qualifications:

  • PharmD or PhD in a relevant scientific field

Competencies:

  • Personal Leadership Skills balanced with Team Orientation
  • Outstanding Communication Skills (oral & written)
  • Goal Orientation
  • Personal Commitment to Improving the Lives of Patients in Need
  • Common Sense
If you would like to apply for this position, please click the button below.
Attach your resume and cover letter, and include job reference code 2013-121 in the subject line.

Director / Sr Director, Regulatory Affairs, CMC

Position Summary:

Reporting to the Chief Medical Officer and Head, Regulatory Affairs, with a dotted line to the Head of Manufacturing and Quality, this person will actively contribute to the development and implementation of a Regulatory CMC strategy for Moderna’s full-length mRNA therapeutic products portfolio and product platform. In addition, the Director/Sr Director, Regulatory Affairs, CMC, will advise management on Regulatory risk and lead interactions with Regulatory agencies on Manufacturing and Quality issues on behalf of Moderna.

Responsibilities:

  • Provide CMC leadership in Moderna’s Regulatory function
  • Work with the Management team to define CMC Regulatory strategy for Moderna’s product platform and portfolio
  • Obtain support for CMC Regulatory strategy and collaborate with the Head of Manufacturing and Quality on its implementation
  • Contribute CMC Regulatory input to relevant project teams
  • Prepare, review and approve, as required, CMC Regulatory documents for submission to regulatory authorities (US & international)
  • In collaboration with Manufacturing and Quality, provide input on the structure and preparation of critical CMC documents such as Manufacturing contracts and Quality Agreements, and contribute to the review and approval of Batch Records and Product QA Release
  • Provide project plans and timelines for CMC Regulatory submission activities
  • Coordinate with Manufacturing and Quality to ensure successful Regulatory submissions
  • Lead communication with FDA and international agencies on CMC issues
  • Identify regulatory CMC experts and consultants and coordinating their interaction with the Company
  • Maintain well-organized and appropriate regulatory files, and provide a monthly CMC Regulatory Intelligence report to ensure the Company is informed of evolving guidelines, rulings and practice in the major regulatory regions

Minimum Qualifications:

  • Minimum 15 years industry experience
  • Minimum 5 years in a senior Regulatory Leadership role
  • Must have a BS in a scientific discipline
  • Track record of successful global CMC filings
  • Able to provide Regulatory leadership on a cross-functional team and work effectively in a matrix organization
  • Capable of strategic thinking and proposing innovative solutions to Regulatory problems
  • Advanced knowledge and experience in interpretation of regulations, guidelines and precedents related to drug development
  • Success working on multiple programs
  • Demonstrates excellent communication skills with ability to impact and influence the decisions of a team
  • Communicate effectively in verbal presentations and in writing regulatory strategy plans and submission documents and act as a liaison/representative both internally and externally
  • Ability to inspire and motivate others to pursue professional excellence

Preferred Qualifications:

  • PharmD or PhD in a relevant scientific field

Competencies:

  • Personal Leadership Skills balanced with Team Orientation
  • Outstanding Communication Skills (oral & written)
  • Goal Orientation
  • Personal Commitment to Improving the Lives of Patients in Need
  • Common Sense
If you would like to apply for this position, please click the button below.
Attach your resume and cover letter, and include job reference code 2013-120 in the subject line.

Standing Out

Moderna is pioneering messenger RNA Therapeutics™, an entirely new in vivo drug modality. We have a robust intellectual property estate including more than 250 patent applications with more than 12,000 claims. We have attracted first-rate leadership and staff and received unprecedented funding of more than $400 million to achieve our ambitious vision. No one else is doing what we do, how we do it.

Outstanding Benefits

In addition to exceptional career opportunities and the fulfillment of improving patient care, Moderna also offers comprehensive benefits including:

  • Exemplary medical/dental/vision insurance and employer funded health care reimbursement account
  • Competitive matching 401K and long-term incentive program
  • Three weeks vacation (to start) and company paid holidays
  • Short/long term disability and life insurance
  • Flexible spending accounts
  • Generous employee referral program
  • Company-provided iPad and iPhone
  • Daily catered lunch
  • Free parking, monthly T pass or subsidized commuter rail pass
  • And more!