Sr. Scientist, Analytical R&D
Merck
July 01, 2026
Remote friendly (West Point, PA)
United States
Operations
Essential Function(s)
- Direct and manage analytical activities within the commercial external manufacturing and testing network.
- Develop and implement site-related analytical strategies; drive continuous improvement of analytical methods and techniques.
- Drive successful analytical execution by contract testing labs to support on-time batch release.
- Review/approve critical analytics documents; act as site representative for method life-cycle tasks.
Responsibilities
- Provide analytical technical oversight with external providers and internal cross-functional stakeholders for large molecule (biologics and/or vaccines) testing.
- Maintain significant on-site presence at external testing providers to oversee critical analytical activities.
- Build and maintain relationships with external entities and internal operations/technology/analytical/procurement; conduct tier/JSC meetings as applicable.
- Support commercial manufacturing facility start-up and sustainability.
- Interface with Global Analytical Working Groups and Global Method Owners/SMEs.
- Drive continuous improvement (assay data trending, corrective actions, proactive tools, best practices).
- Identify and resolve analytical issues, deviations, and out-of-specification results from external labs; lead/support investigations.
- Build and manage project plans, timelines, and schedules.
- Prepare external testing sites for inspections (e.g., FDA, EMA, PMDA) from an analytical perspective.
- Author and/or review technical documents supporting PPQ, licensure, and regulatory technical questions.
Qualifications (Education/Experience)
- BS/BA (bio/chem/biochem or related) + 6 years; or MS/MA + 4 years; or PhD + 2 years in analytical testing/development/transfer/validation.
Required Skills
- 4+ years in a GXP lab environment in large molecule analytics (vaccines/biologics) or cross-modality compounds.
- Analytical product life cycle experience (development, validation, and/or transfer) across platforms (e.g., ELISA, HPLC, CE).
- Biologics analytics understanding (bioassays, chromatography) and biochemistry methods.
- Biopharmaceutical manufacturing experience (commercialization, technical operations, and/or QC).
- Knowledge of in-process controls, DS/DP release, stability, extended characterization testing.
- Regulatory knowledge (ICH, USP, Ph. Eur., JP).
- Strong project management and oral/written communication.
Preferred Skills
- Deviation management/change control; troubleshoot/analyze analytical data.
- Method transfer/validation and lifecycle across franchises; experience with CMOs/CTLs.
- LIMS and automation/digital systems (e.g., Veeva Vault, MEDs, IPI, Spotfire).
Benefits
- Eligible for annual bonus and long-term incentive (if applicable).
- Comprehensive benefits include medical/dental/vision, retirement (401(k)), paid holidays/vacation, and sick/compassionate days.
Application
- Apply via https://jobs.merck.com/us/en (Workday Jobs Hub for current employees). Application deadline is stated on the posting.
- Direct and manage analytical activities within the commercial external manufacturing and testing network.
- Develop and implement site-related analytical strategies; drive continuous improvement of analytical methods and techniques.
- Drive successful analytical execution by contract testing labs to support on-time batch release.
- Review/approve critical analytics documents; act as site representative for method life-cycle tasks.
Responsibilities
- Provide analytical technical oversight with external providers and internal cross-functional stakeholders for large molecule (biologics and/or vaccines) testing.
- Maintain significant on-site presence at external testing providers to oversee critical analytical activities.
- Build and maintain relationships with external entities and internal operations/technology/analytical/procurement; conduct tier/JSC meetings as applicable.
- Support commercial manufacturing facility start-up and sustainability.
- Interface with Global Analytical Working Groups and Global Method Owners/SMEs.
- Drive continuous improvement (assay data trending, corrective actions, proactive tools, best practices).
- Identify and resolve analytical issues, deviations, and out-of-specification results from external labs; lead/support investigations.
- Build and manage project plans, timelines, and schedules.
- Prepare external testing sites for inspections (e.g., FDA, EMA, PMDA) from an analytical perspective.
- Author and/or review technical documents supporting PPQ, licensure, and regulatory technical questions.
Qualifications (Education/Experience)
- BS/BA (bio/chem/biochem or related) + 6 years; or MS/MA + 4 years; or PhD + 2 years in analytical testing/development/transfer/validation.
Required Skills
- 4+ years in a GXP lab environment in large molecule analytics (vaccines/biologics) or cross-modality compounds.
- Analytical product life cycle experience (development, validation, and/or transfer) across platforms (e.g., ELISA, HPLC, CE).
- Biologics analytics understanding (bioassays, chromatography) and biochemistry methods.
- Biopharmaceutical manufacturing experience (commercialization, technical operations, and/or QC).
- Knowledge of in-process controls, DS/DP release, stability, extended characterization testing.
- Regulatory knowledge (ICH, USP, Ph. Eur., JP).
- Strong project management and oral/written communication.
Preferred Skills
- Deviation management/change control; troubleshoot/analyze analytical data.
- Method transfer/validation and lifecycle across franchises; experience with CMOs/CTLs.
- LIMS and automation/digital systems (e.g., Veeva Vault, MEDs, IPI, Spotfire).
Benefits
- Eligible for annual bonus and long-term incentive (if applicable).
- Comprehensive benefits include medical/dental/vision, retirement (401(k)), paid holidays/vacation, and sick/compassionate days.
Application
- Apply via https://jobs.merck.com/us/en (Workday Jobs Hub for current employees). Application deadline is stated on the posting.