Associate Principal Scientist, Analytical R&D
Merck
12 days ago
On-site
Durham, NC
Operations
Associate Principal Scientist (Live Virus Vaccines, LVV)
Responsibilities:
- Work with Analytical Product Leaders (APLs) to develop and implement commercialization analytical strategy across testing nodes.
- Participate in significant investigations across the viral vaccines franchise.
- Provide subject method expertise to QC analysts/supervisors; assess impact of proposed changes and deviations.
- Support assay modernization and harmonized network solutions across QC labs; partner with Digital manufacturing/LMAS for assay digitization and harmonized data capture.
- Partner with the BCR hub to develop short- and mid-term strategy for BCR sustainability and antisera generation; connect BCR performance with assay performance.
- Provide SME support to APLC gap assessments to drive robust, sustainable methods.
- Present and discuss method performance data and develop actions 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 in a timely, concise manner.
- Support RTQs, PAI readiness, and audit observations.
Minimum Education/Experience:
- BS/BA in sciences + 6 years analytical testing/development/transfer/validation; OR MS/MA + 4 years; OR PhD + 2 years.
Required Skills/Experience:
- Demonstrated analytics experience for commercial vaccine and/or microbiological products.
- Communication/teamwork; leading cross-functional teams.
- Large molecule GMP testing experience (stability and release testing).
- Analytical comparability; strong technical expertise in large-molecule analytical lab operations.
Preferred Skills:
- Continuous improvement or project management training.
- Technical document/regulatory writing and reviews (IND/MAA/BLA/PAS/CBE) and inspections.
- Analytical transfers; commercial method changes; assay monitoring/trending.
Required Skills (examples listed):
- Analytical method development, assay development, cell-based assays, chromatographic techniques, LC-MS/HRMS, PAT, protein analysis, cross-functional teamwork, external collaboration.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline is per posting; Job posting end date: 06/6/2026. Requisition ID: R397523.
Responsibilities:
- Work with Analytical Product Leaders (APLs) to develop and implement commercialization analytical strategy across testing nodes.
- Participate in significant investigations across the viral vaccines franchise.
- Provide subject method expertise to QC analysts/supervisors; assess impact of proposed changes and deviations.
- Support assay modernization and harmonized network solutions across QC labs; partner with Digital manufacturing/LMAS for assay digitization and harmonized data capture.
- Partner with the BCR hub to develop short- and mid-term strategy for BCR sustainability and antisera generation; connect BCR performance with assay performance.
- Provide SME support to APLC gap assessments to drive robust, sustainable methods.
- Present and discuss method performance data and develop actions 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 in a timely, concise manner.
- Support RTQs, PAI readiness, and audit observations.
Minimum Education/Experience:
- BS/BA in sciences + 6 years analytical testing/development/transfer/validation; OR MS/MA + 4 years; OR PhD + 2 years.
Required Skills/Experience:
- Demonstrated analytics experience for commercial vaccine and/or microbiological products.
- Communication/teamwork; leading cross-functional teams.
- Large molecule GMP testing experience (stability and release testing).
- Analytical comparability; strong technical expertise in large-molecule analytical lab operations.
Preferred Skills:
- Continuous improvement or project management training.
- Technical document/regulatory writing and reviews (IND/MAA/BLA/PAS/CBE) and inspections.
- Analytical transfers; commercial method changes; assay monitoring/trending.
Required Skills (examples listed):
- Analytical method development, assay development, cell-based assays, chromatographic techniques, LC-MS/HRMS, PAT, protein analysis, cross-functional teamwork, external collaboration.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline is per posting; Job posting end date: 06/6/2026. Requisition ID: R397523.