Associate Principal Scientist, Analytical R&D
Merck
13 days ago
On-site
West Point, PA
Clinical Research and Development
Associate Principal Scientist (Live Virus Vaccines, LVV)
Responsibilities:
- Partner with Analytical Product Leaders (APLs) to develop and implement commercialization analytical strategy across testing nodes; support transition from clinical to commercial stages.
- Drive method alignment and support consistent execution excellence across multiple testing laboratories.
- Develop and maintain assay monitoring/trending and support method procedure life-cycle management, including automation/modernization.
- Participate in significant investigations across the viral vaccines franchise.
- Serve as Subject Matter Expert (SME) for QC analysts/supervisors; assess impact of proposed changes and deviations.
- In partnership with AWG and network QC labs, define and implement assay modernization investments; support harmonized network solutions and assay digitization/harmonized data capture.
- In partnership with the BCR hub, develop short/mid-term sustainability strategy for BCR inventory and antisera generation; connect BCR and assay performance.
- Provide SME support for APLC gap assessments to improve robustness; present/discuss method performance data at analytical working group meetings.
- Collaborate with internal/external partners (including international governments, CMO/CRO) to ensure uninterrupted supply; escalate key assay challenges to management.
- Support RTQs, PAI readiness, and audit observations.
Minimum Education/Experience:
- BS/BA (sciences) + 6 years analytical testing, development, transfer, and/or validation; OR MS/MA (sciences) + 4 years; OR PhD (sciences) + 2 years.
Required Skills/Experience:
- Analytics experience for commercial vaccine and/or microbiological products.
- Large molecule GMP testing (stability and release testing), analytical comparability, cross-functional leadership.
- Strong technical expertise in large molecule analytical lab operations, equipment, and techniques; effective communication/teamwork.
Preferred Skills/Experience:
- Continuous improvement or Project Management training; technical writing/review for regulatory filings and inspections.
- Large molecule analytical transfers; commercial analytical method changes; assay monitoring/trending.
Responsibilities:
- Partner with Analytical Product Leaders (APLs) to develop and implement commercialization analytical strategy across testing nodes; support transition from clinical to commercial stages.
- Drive method alignment and support consistent execution excellence across multiple testing laboratories.
- Develop and maintain assay monitoring/trending and support method procedure life-cycle management, including automation/modernization.
- Participate in significant investigations across the viral vaccines franchise.
- Serve as Subject Matter Expert (SME) for QC analysts/supervisors; assess impact of proposed changes and deviations.
- In partnership with AWG and network QC labs, define and implement assay modernization investments; support harmonized network solutions and assay digitization/harmonized data capture.
- In partnership with the BCR hub, develop short/mid-term sustainability strategy for BCR inventory and antisera generation; connect BCR and assay performance.
- Provide SME support for APLC gap assessments to improve robustness; present/discuss method performance data at analytical working group meetings.
- Collaborate with internal/external partners (including international governments, CMO/CRO) to ensure uninterrupted supply; escalate key assay challenges to management.
- Support RTQs, PAI readiness, and audit observations.
Minimum Education/Experience:
- BS/BA (sciences) + 6 years analytical testing, development, transfer, and/or validation; OR MS/MA (sciences) + 4 years; OR PhD (sciences) + 2 years.
Required Skills/Experience:
- Analytics experience for commercial vaccine and/or microbiological products.
- Large molecule GMP testing (stability and release testing), analytical comparability, cross-functional leadership.
- Strong technical expertise in large molecule analytical lab operations, equipment, and techniques; effective communication/teamwork.
Preferred Skills/Experience:
- Continuous improvement or Project Management training; technical writing/review for regulatory filings and inspections.
- Large molecule analytical transfers; commercial analytical method changes; assay monitoring/trending.