Associate Principal Scientist, Analytical R&D
Job in
Wilmington, New Hanover County, North Carolina, 28412, USA
Listed on 2026-07-13
Listing for:
Jobtailor
Full Time
position Listed on 2026-07-13
Job specializations:
-
Science
Research Scientist, Data Scientist, Clinical Research, Pharmaceutical Science/ Research
Job Description & How to Apply Below
- Work with APLs to develop and implement the commercialization analytical strategy across testing nodes.
- Participate in significant investigations across the viral vaccines franchise.
- Provide Subject Method Expertise to QC analysts and supervisors, assess impact of proposed changes and deviations.
- In partnership with the AWG and network QC labs, support definition of the opportunities for improvement/investment in equipment and technology required to drive assay modernization and implement harmonized network solutions.
- This includes working with our Digital manufacturing Division and LMAS team for assay digitization with harmonized data capture.
- In partnership with the BCR hub, develop short and mid-term strategy for sustainability in BCR inventory and antisera generation needed to support all testing laboratories in the network and connect BCR performance with assay performance as noted above.
- Provide SME support to APLC gap assessments of key methods to drive improved and sustainable robustness.
- Ensure method performance data are presented, discussed and actions developed at analytical working group meetings as appropriate.
- Collaborate across the internal network, external partners, international governments and/or contract manufacturing and research organizations (CMO/CRO) to ensure uninterrupted supply.
- Escalate key assay challenges to management in a timely and concise manner.
- Support RTQs, PAI readiness and audit observations.
- Bachelor’s Degree (BA/BS) with a concentration in sciences with six (6) years of experience working in the field of analytical testing, development, transfer, and/or validation; OR Master’s Degree (MA/MS) with a concentration in sciences with four (4) years of experience working in the field of analytical testing, development, transfer, and/or validation; OR PhD with a concentration in sciences with two (2) years of experience working in the field of analytical testing, development, transfer, and/or validation.
- Demonstrated experience with analytics for commercial vaccine and/or microbiological products.
- Effective communication and teamwork.
- Experience with large molecule GMP testing, including drug substance and drug product stability and release testing.
- Experience with analytical comparability.
- Experience leading a cross-functional team.
- Strong technical expertise in general large molecule analytical laboratory operations, equipment, and techniques.
Position Requirements
10+ Years
work experience
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