Senior Raw Materials Analytics & Characterization

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

Benefits offered by this job

Medical, dental, vision insurance

401(k) plan with company match

Paid holidays and vacation

Job summary

Merck in the United States (Pennsylvania) seeks a scientist to lead analytical characterization and oversight of raw materials for biologics manufacturing. You will define CMAs, assess risk, engage suppliers, and ensure robust processes, product quality, and supply continuity.

You will develop analytical methods, apply orthogonal approaches, and collaborate across Manufacturing, Quality, Procurement, and Regulatory Affairs. GMP, USP/EP/QB standards apply; domestic relocation may be available.

Qualifications

• Bachelor’s degree with 6+ years of relevant experience; OR Master’s with 4+ years; OR Ph.D. with no industry experience.
• Experience in biopharmaceutical/biotechnology analytical sciences or materials characterization.
• Knowledge of GMP, regulatory expectations, and quality systems.

Responsibilities

• Lead raw material characterization programs for biologics manufacturing.
• Identify CMAs and assess impact on process performance and CQAs.
• Develop strategies to evaluate composition, purity, impurity profiles, stability, and lot variability.
• Collaborate with cross-functional teams to mitigate material-related risks.
• Support supplier qualification, technology transfers, and regulatory submissions.

Skills

Analytical chemistry

Data analysis

Cross-functional PM

Regulatory compliance

Technical transfer

Problem solving

Education

Bachelor’s in Analytical Chemistry/related

Master’s in Analytical Chemistry/related

Ph.D. in scientific field

Tools

HPLC

LC-MS

LC-MS/MS

GC-MS

ICP-MS

Job description

Merck in the United States (Pennsylvania) seeks a scientist to lead analytical characterization and oversight of raw materials for biologics manufacturing. You will define CMAs, assess risk, engage suppliers, and ensure robust processes, product quality, and supply continuity.

You will develop analytical methods, apply orthogonal approaches, and collaborate across Manufacturing, Quality, Procurement, and Regulatory Affairs. GMP, USP/EP/QB standards apply; domestic relocation may be available.