Senior Specialist, Raw Material Analytical Characterization

Merck · West Point, PA

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CMCFull-time$117k–$184kCompany career page

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Role summary

Merck seeks a Senior Specialist to lead analytical characterization and risk assessment of raw materials for biologics manufacturing. The role focuses on identifying critical material attributes, evaluating supplier variability, and developing control strategies to ensure process robustness and product quality through cross-functional collaboration.

What they're looking for

Bachelor's degree with 6+ years relevant experience, or Master's with 4+ years, or Ph.D.
Expertise in analytical chemistry, materials characterization, or biophysical characterization methods.
Experience developing and applying analytical methods to characterize complex materials.
Understanding of raw material variability impact on bioprocess performance and product quality.
Strong scientific problem-solving, data interpretation, and investigation skills.
Proven ability to lead scientific projects and work across cross-functional teams.
Knowledge of compendial methods and pharmacopeial standards (USP, EP, JP, BP).

What you'll be doing

Develop characterization programs for raw materials including media, feeds, amino acids, vitamins, and excipients.
Identify and assess Critical Material Attributes and their impact on process performance and product quality.
Develop analytical methods and apply advanced techniques to identify impurities and supplier differences.
Partner with Manufacturing, Quality, Process Development, and suppliers to assess and mitigate material risks.
Support regulatory filings, inspections, and quality investigations with scientific data packages.

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