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The Role:
Moderna is seeking a senior leader at Director level, to lead the Bioassay group for Analytical Development within Technology Development based at their Norwood, MA site. The individual will lead team functions for development and performance of cellular and biochemical bioassays as well as CMC in vivo studies to support advancement of Moderna’s mRNA early, late development programs and commercial products. This leadership position will collaborate with other groups within Analytical Development and Technology Development including Process Development, Analytical Science & Technology, Quality Control and Platform Research groups for the development and execution of potency testing strategies for Moderna’s mRNA clinical development candidates. Guiding and leading activities from early assay development, through optimization and qualification, and transfer to Quality Control for GMP testing.
Here’s What You’ll Do:
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Lead and build Moderna’s Analytical Development Bioassay Team with the Analytical leadership team to meet the expanding needs for bioassays supporting potency evaluation of the pipeline and towards commercialization.
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Develop science-driven, phase appropriate, and risk-based analytical bioassay strategies to support development projects from initiation of clinical development through to commercial manufacture.
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Work with Analytical leadership to establish potency testing strategies that meet global regulations for analytical potency testing and characterization of mRNA vaccines and therapeutics.
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Participate effectively in internal development programs and external collaborations.
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Mentor and develop analytical bioassay staff to function effectively in cross-functional teams and collaborations.
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Lead/participate in CRO selection and relationship managing for externalized activities, as needed.
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Interact effectively and transparently with functional heads and stakeholders within Moderna, (TDLT, Quality, Toxicology, DMPK, Clinical Pharmacology, Regulatory CMC, Clinical and Commercial Manufacturing, Project Leadership, Business Development, Alliance Management, etc.).
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Hold reviewer/approver/author responsibility for appropriate CMC sections of regulatory submissions.
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Provide input into personnel decisions including performance appraisals, promotions, hiring, mentoring, and other personnel related activities across Analytical Development.
Here’s What You’ll Bring to the Table:
Minimum Qualifications:
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PhD in Biological Sciences with over 8 years of experience or MSc in Biological Sciences with over 12 years of experience in the development of bioassays.
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Experience developing and optimizing cell-based assays with demonstrated breadth of understanding around factors influencing their performance.
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Experience with ligand-binding assay development and performance (ELISA, MSD, FACS, Luminex, other)
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Experience in method development, method qualification and validation, and method transfer to a Quality Control group or CRO for GMP sample testing.
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Demonstrated understanding of Regulatory guidance for bioassays and potency testing
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Experience with Regulatory filings and/or agency interactions (IND, BLA, MAA and RTQ).
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Demonstrated leadership and management of high-performing teams.
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Excellent interpersonal and organizational skills, strong attention to detail, and demonstrated ability to collaborate effectively on cross-functional teams and within a dynamic environment.
Preferred Qualifications:
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Experience with bioassay development and defining potency testing strategy for biotherapeutics.
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Experience with mRNA or other gene therapy modalities
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Experience in an industrial setting or GxP environment
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Experience with in vivo testing, particularly for the evaluation of biotherapeutics.
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Experience establishing and managing interactions with CROs.
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
- Highly competitive and inclusive medical, dental and vision coverage options
- Flexible Spending Accounts for medical expenses and dependent care expenses
- Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
- Family care benefits, including subsidized back-up care options and on-demand tutoring
- Free premium access to fitness, nutrition, and mindfulness classes
- Exclusive preferred pricing on Peloton fitness equipment
- Adoption and family-planning benefits
- Dedicated care coordination support for our LGBTQ+ community
- Generous paid time off, including:
• Vacation, sick time and holidays
• Volunteer time to participate within your community
• Discretionary year-end shutdown
• Paid sabbatical after 5 years; every 3 years thereafter - Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
- 401k match and Financial Planning tools
- Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
- Complimentary concierge service including home services research, travel booking, and entertainment requests
- Free parking or subsidized commuter passes
- Location-specific perks and extras!
About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit (url removed).
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at (url removed). (EEO/AAP Employer)
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