Lead Raw Material Analytics for Biologics

Merck & Co.; West Point (PA); On-site; USD 117,000 - 184,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Medical insurance

Retirement benefits (401(k))

Job summary

Merck & Co. in the United States is seeking a scientist to lead analytical characterization and oversight of raw materials used in biologics manufacturing. You will identify CMAs, evaluate variability, and develop risk-based strategies for media, feeds, and other inputs.

Collaborating with Manufacturing, Quality, Regulatory, and suppliers, you will implement tests, ensure GMP alignment, and support regulatory submissions while advancing supply continuity.

Qualifications

• Bachelor's, Master's, or Ph.D. in Analytical Chemistry, Chemistry, Biochemistry, Chemical Engineering, Materials Science, Pharmaceutical Sciences, Biological Sciences, or related field.
• 6+ years with Bachelor's, 4+ years with Master's; Ph.D. with no industry experience acceptable.
• Experience in biopharmaceuticals, analytical sciences, materials characterization, or quality operations.

Responsibilities

• Lead raw material characterization programs for biologics inputs including media, feeds, amino acids, vitamins, and excipients.
• Identify CMAs and assess their impact on process performance and CQAs.
• Develop strategies to evaluate composition, purity, impurities, stability, and lot-to-lot variability.
• Collaborate with Manufacturing, Procurement, Quality, Regulatory, and external suppliers.
• Support qualification of new materials, suppliers, and alternate sourcing.

Skills

Analytical chemistry

Materials characterization

Bioprocessing

Analytical methods development

Data interpretation

Cross-functional collaboration

Project leadership

Education

Analytical Chemistry / Chemistry / Biochemistry / Chemical Engineering

Tools

HPLC/LC-MS

LC‑MS/MS

GC‑MS / ICP‑MS

Job description

Merck & Co. in the United States is seeking a scientist to lead analytical characterization and oversight of raw materials used in biologics manufacturing. You will identify CMAs, evaluate variability, and develop risk-based strategies for media, feeds, and other inputs.

Collaborating with Manufacturing, Quality, Regulatory, and suppliers, you will implement tests, ensure GMP alignment, and support regulatory submissions while advancing supply continuity.