Senior Scientist - Biologics Analytics and GMP Operations

Merck; North Wales (Montgomery County); On-site; USD 117,000 - 184,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement benefits

Paid holidays

Vacation

Sick days

Job summary

Merck in North Wales, PA, is seeking a Senior Scientist to join Biologics Analytical Research & Development GMP Operations. You will apply separation-based analyses (HPLC, UPLC, CE, iCIEF) to support method optimization, validation, transfers, and lifecycle management for biologics.

Cross-functional collaboration with QA, regulatory, and operations is essential. The role emphasizes GMP discipline, data integrity, and readiness for clinical material testing and commercialization.

Qualifications

• Ph.D. or higher with relevant GMP experience.
• Proven experience in separation-based analytical methods.
• Strong regulatory and cross-functional collaboration skills.

Responsibilities

• Validate, implement, transfer, and maintain analytical methods for clinical material testing and commercialization readiness.
• Lead validation and testing activities across programs with external stakeholders.
• Serve as SME across biologics programs and analytical platforms.
• Interpret data, assess trends, and support investigations and CAPAs.
• Oversee GMP release, stability, and in-process testing for biologics.
• Provide recommendations to address technical challenges and support decisions.
• Support biologics registrations, launches, and troubleshooting.
• Manage project timelines and deliverables to milestones.
• Support audits, inspections, and CAPA activities with disciplined documentation.
• Ensure activities comply with cGMP and data integrity requirements.
• Support IQ/OQ/PQ instrument qualification.
• Contribute to regulatory submissions and strategic initiatives.
• Adapt to evolving priorities with flexible scientific contributions.

Skills

GMP experience

Analytical methods

HPLC

UPLC

CE

iCIEF

LIMS

Empower

Education

Ph.D. in Biology/Chemistry/Biochemistry/Pharmaceutical Sciences

M.S. in related field

B.S. in related field

Tools

Electronic notebooks

Job description

Merck in North Wales, PA, is seeking a Senior Scientist to join Biologics Analytical Research & Development GMP Operations. You will apply separation-based analyses (HPLC, UPLC, CE, iCIEF) to support method optimization, validation, transfers, and lifecycle management for biologics.

Cross-functional collaboration with QA, regulatory, and operations is essential. The role emphasizes GMP discipline, data integrity, and readiness for clinical material testing and commercialization.