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Principal Research Associate, Analytical Science & Technology
Company | Moderna |
Address | Norwood, MA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Biotechnology Research |
Expires | 2023-11-18 |
Posted at | 9 months ago |
The Role:
- Support responses to compliance audits.
- Support efforts for method troubleshooting, remediation, change and optimization efforts in conjunction with Quality Control and Analytical Development.
- Author Qualification Master Plans.
- Monitor and communicate method lifecycle (acquisition, transfer, qualification / validation, implementation) timelines using project management tools.
- Provide CMC Filing Support, including INDs, BLAs, etc.
- Coordinate AS&T lab method readiness activities and project timelines.
- Act as the liaison between Analytical Development and AS&T Functions.
- Coordinate training between development and AS&T teams.
- Coordinate SME to SME discussion and collaboration with internal and external teams.
- Maintain a safe laboratory working environment
- Lead the Program Management for internal Analytical method transfers and qualification activities into AS&T and out to QC labs.
- Project management of external analytical method transfers and co-qualifications at external CMOs and CTLs.
- Lead cross-functional meetings between AS&T and support groups.
- As part of the Analytical Science & Technology team, your primary responsibilities will be as follows:
- Other responsibilities as needed.
- Demonstrated knowledge of method transfer activities.
- Excellent troubleshooting and ability to communicate issues in a scientifically sound and understandable way
- Ability to efficiently and independently prioritize, manage and complete multiple projects and tasks in a fast-paced environment
- Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations
- Excellent communication skills (verbal and written)
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment
- Minimum Education requires: Bachelor’s degree in Sciences and 5-8 years of industry experience in a cGMP laboratory setting focused on analytical chemistry.
- Minimum education required: Bachelor’s degree in a relevant scientific discipline
- Complimentary concierge service including home services research, travel booking, and entertainment requests
- 401k match and Financial Planning tools
- Location-specific perks and extras!
- Discretionary year-end shutdown
- Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
- Highly competitive and inclusive medical, dental and vision coverage options
- Flexible Spending Accounts for medical expenses and dependent care expenses
- Dedicated care coordination support for our LGBTQ+ community
- Family care benefits, including subsidized back-up care options and on-demand tutoring
- Exclusive preferred pricing on Peloton fitness equipment
- Free premium access to fitness, nutrition, and mindfulness classes
- Paid sabbatical after 5 years; every 3 years thereafter
- Free parking or subsidized commuter passes
- Generous paid time off, including:
- Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
- Adoption and family-planning benefits
- Volunteer time to participate within your community
- Vacation, sick time and holidays
- Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
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