Sr. Scientist, Analytical R&D
Merck
July 01, 2026
Remote friendly (De Forest, WI)
United States
Operations
Essential Functions:
- Direct and manage analytical activities in the external commercial manufacturing/testing network for large molecules (vaccines/biologics) and cross-modality compounds.
- Develop and implement site analytical strategies; drive continuous improvement of analytical methods and techniques; ensure on-time batch release via contract lab(s).
- Oversee critical analytics documentation, approve analytics-related documents, and participate in method lifecycle tasks as a site representative.
Responsibilities:
- Provide analytical technical oversight with external providers and internal stakeholders; significant on-site presence for critical analytical testing.
- Build relationships with external/internal teams; support tier and joint steering committee meetings.
- Collaborate with commercial manufacturing teams for facility start-up/sustainment.
- Drive continuous improvement (tools, assay data trending, corrective actions, best practices).
- Identify and resolve analytical issues/deviations/OOS results through investigation/troubleshooting.
- Lead/support complex investigations; build and manage project plans/timelines.
- Ensure sites are inspection-ready (analytical perspective) for FDA/EMA/PMDA.
- Author/review technical documents for PPQ, licensure, and regulatory technical questions.
Qualifications & Skills:
- BS + 6 yrs (or MS + 4 yrs, or PhD + 2 yrs) in relevant sciences with analytical testing/development/transfer/validation.
- 4+ yrs in GXP lab environment for large molecules analytics or cross-modality compounds.
- Experience with analytical product life cycle (development/validation/transfer) using ELISA, HPLC, CE; biologics methods (bioassays, chromatography).
- Biopharmaceutical manufacturing experience (tech ops/QC), ICH/USP/Ph. Eur./JP regulatory knowledge.
- Strong communication, organizational, and project management skills.
Preferred:
- Deviation/change control knowledge; analytical data troubleshooting; method transfer/validation; experience with CMOs/CTLs; LIMS; automation/digital systems.
Compensation & Benefits (if applicable):
- Salary range: $117,000.00–$184,200.00; eligible for annual bonus/long-term incentive (if applicable).
- Comprehensive benefits including medical/dental/vision, retirement (401(k)), paid holidays/vacation.
Application Instructions:
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline is stated on the posting.
- Direct and manage analytical activities in the external commercial manufacturing/testing network for large molecules (vaccines/biologics) and cross-modality compounds.
- Develop and implement site analytical strategies; drive continuous improvement of analytical methods and techniques; ensure on-time batch release via contract lab(s).
- Oversee critical analytics documentation, approve analytics-related documents, and participate in method lifecycle tasks as a site representative.
Responsibilities:
- Provide analytical technical oversight with external providers and internal stakeholders; significant on-site presence for critical analytical testing.
- Build relationships with external/internal teams; support tier and joint steering committee meetings.
- Collaborate with commercial manufacturing teams for facility start-up/sustainment.
- Drive continuous improvement (tools, assay data trending, corrective actions, best practices).
- Identify and resolve analytical issues/deviations/OOS results through investigation/troubleshooting.
- Lead/support complex investigations; build and manage project plans/timelines.
- Ensure sites are inspection-ready (analytical perspective) for FDA/EMA/PMDA.
- Author/review technical documents for PPQ, licensure, and regulatory technical questions.
Qualifications & Skills:
- BS + 6 yrs (or MS + 4 yrs, or PhD + 2 yrs) in relevant sciences with analytical testing/development/transfer/validation.
- 4+ yrs in GXP lab environment for large molecules analytics or cross-modality compounds.
- Experience with analytical product life cycle (development/validation/transfer) using ELISA, HPLC, CE; biologics methods (bioassays, chromatography).
- Biopharmaceutical manufacturing experience (tech ops/QC), ICH/USP/Ph. Eur./JP regulatory knowledge.
- Strong communication, organizational, and project management skills.
Preferred:
- Deviation/change control knowledge; analytical data troubleshooting; method transfer/validation; experience with CMOs/CTLs; LIMS; automation/digital systems.
Compensation & Benefits (if applicable):
- Salary range: $117,000.00–$184,200.00; eligible for annual bonus/long-term incentive (if applicable).
- Comprehensive benefits including medical/dental/vision, retirement (401(k)), paid holidays/vacation.
Application Instructions:
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub). Application deadline is stated on the posting.