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Principal Research Associate, Drug Product Development
Company | Moderna |
Address | Norwood, MA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Biotechnology Research |
Expires | 2023-09-11 |
Posted at | 10 months ago |
The Role:
- Participate in Drug Product teams responsible for Drug Product formulation and process development for pipeline and lifecycle management projects
- Maintain meticulous records through ELN and report authoring to ensure documentation compliance in support of cGMP activities
- Design, execute, and document studies to characterize and/or scale-up various fill/finish unit operations (freeze/thaw, mixing, filtration, filling, visual inspection, etc.)
- Develop approaches and execute studies to evaluate the compatibility of Drug Product with processing materials, container closure components, and sterilization processes.
- Support authoring and review of regulatory submissions
- Enable development of container closure options for Moderna clinical and commercial products by establishing test protocols and procedures as well as partnerships with external partners as required.
- Lead multiple activities in parallel to drive projects to completion, meeting timelines and key deliverables
- Experience in clinical or commercial Drug Product (or related) GMP technology transfer and validation would be a plus.
- Exceptional laboratory skills and demonstrated knowledge in fill/finish unit operation characterization and scale up
- Knowledge of GMP and GLP compliance
- Ability to perform data analysis using advanced statistical, including design of experiments (DoE) approaches leveraging statistical analysis software
- Masters or Bachelor’s or Master’s Degree in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Biochemistry, or related discipline with a minimum of 5 (Bachelor’s) or 2 (Master’s) years industry experience in biopharmaceutical development
- Hands-on experience with aseptic liquid filling of vials, pre-filled syringes, and/or cartridges. Familiar with current varieties and suppliers of parenteral container closure systems.
- Exclusive preferred pricing on Peloton fitness equipment
- Volunteer time to participate within your community
- Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
- Family care benefits, including subsidized back-up care options and on-demand tutoring
- Dedicated care coordination support for our LGBTQ+ community
- Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
- Free parking or subsidized commuter passes
- Highly competitive and inclusive medical, dental and vision coverage options
- Free premium access to fitness, nutrition, and mindfulness classes
- Adoption and family-planning benefits
- Location-specific perks and extras!
- Paid sabbatical after 5 years; every 3 years thereafter
- Generous paid time off, including:
- Complimentary concierge service including home services research, travel booking, and entertainment requests
- Discretionary year-end shutdown
- Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
- Vacation, sick time and holidays
- Flexible Spending Accounts for medical expenses and dependent care expenses
- 401k match and Financial Planning tools
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