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Director, Analytical Development Jobs
Company | Moderna |
Address | Norwood, MA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Biotechnology Research |
Expires | 2023-09-03 |
Posted at | 8 months ago |
The Role:
- Develop science-driven, phase appropriate, and risk-based analytical bioassay strategies to support development projects from initiation of clinical development through to commercial manufacture.
- Lead/participate in CRO selection and relationship managing for externalized activities, as needed.
- Provide input into personnel decisions including performance appraisals, promotions, hiring, mentoring, and other personnel related activities across Analytical Development.
- 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.
- Participate effectively in internal development programs and external collaborations.
- 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.).
- Hold reviewer/approver/author responsibility for appropriate CMC sections of regulatory submissions.
- Mentor and develop analytical bioassay staff to function effectively in cross-functional teams and collaborations.
- Work with Analytical leadership to establish potency testing strategies that meet global regulations for analytical potency testing and characterization of mRNA vaccines and therapeutics.
- Experience developing and optimizing cell-based assays with demonstrated breadth of understanding around factors influencing their performance.
- Excellent interpersonal and organizational skills, strong attention to detail, and demonstrated ability to collaborate effectively on cross-functional teams and within a dynamic environment.
- Demonstrated leadership and management of high-performing teams.
- Demonstrated understanding of Regulatory guidance for bioassays and potency testing
- Experience in method development, method qualification and validation, and method transfer to a Quality Control group or CRO for GMP sample testing.
- 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.
- Experience with ligand-binding assay development and performance (ELISA, MSD, FACS, Luminex, other)
- Experience with Regulatory filings and/or agency interactions (IND, BLA, MAA and RTQ).
- Experience with bioassay development and defining potency testing strategy for biotherapeutics.
- Experience in an industrial setting or GxP environment
- Experience establishing and managing interactions with CROs.
- Experience with in vivo testing, particularly for the evaluation of biotherapeutics.
- Experience with mRNA or other gene therapy modalities
- Free parking or subsidized commuter passes
- Free premium access to fitness, nutrition, and mindfulness classes
- Flexible Spending Accounts for medical expenses and dependent care expenses
- Adoption and family-planning benefits
- Discretionary year-end shutdown
- Complimentary concierge service including home services research, travel booking, and entertainment requests
- Location-specific perks and extras!
- Highly competitive and inclusive medical, dental and vision coverage options
- Generous paid time off, including:
- Family care benefits, including subsidized back-up care options and on-demand tutoring
- Dedicated care coordination support for our LGBTQ+ community
- Volunteer time to participate within your community
- Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
- Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
- 401k match and Financial Planning tools
- 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
- Vacation, sick time and holidays
- Exclusive preferred pricing on Peloton fitness equipment
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