Senior Specialist, Raw Material Analytical Characterization

Job Description

The Biologics Raw Materials team within Biologics Drug Substance & Commercialization (BDSC) is seeking a highly motivated scientist to lead analytical characterization and technical oversight of raw materials used in biologics manufacturing. This role will focus on understanding and controlling raw material variability through analytical characterization, risk assessment, and supplier engagement to ensure robust manufacturing processes, product quality, and supply continuity.

The successful candidate will apply expertise in analytical chemistry, materials characterization, and bioprocessing to identify critical material attributes (CMAs), evaluate supplier and lot-to-lot variability, and develop risk‑based strategies for raw materials used in cell culture media, feeds, and other critical manufacturing inputs. The role requires close collaboration with Manufacturing, Quality, Procurement, Supply Chain, Regulatory Affairs, Process Development, and external suppliers.

• Develop raw material characterization program for raw materials used in biologics manufacturing, including cell culture media, feeds, amino acids, vitamins, trace elements, salts, and excipients.
• Identify and assess Critical Material Attributes (CMAs) and their impact on process performance, product quality, and Critical Quality Attributes (CQAs).
• Develop characterization strategies to evaluate composition, purity, impurity profiles, stability, and lot-to-lot variability.
• Investigate sources of raw material variation and work with process teams to better understand potential impact on cell growth, productivity, glycosylation, aggregation, potency, and product quality.
• Apply risk‑based approaches to prioritize materials based on process impact, product quality risk, supplier performance, traceability, and supply chain complexity.
• Support qualification of new materials, suppliers, and alternate sourcing strategies.
• Strong knowledge of compendial methods and pharmacopeial standards (USP, EP, JP, BP), including their application to raw material testing and characterization. Demonstrated ability to evaluate, harmonize, and standardize test methods across compendial, supplier, and internal laboratories.

• Develop analytical methods used for raw material characterization.
• Apply advanced analytical techniques to identify and quantify impurities, trace contaminants, degradation products, and supplier‑to‑supplier differences.
• Utilize orthogonal analytical approaches to generate comprehensive material characterization packages.
• Evaluate and implement innovative analytical technologies that improve understanding of raw material variability.

• Partner with Manufacturing, Process Development, Quality, Procurement, Supply Chain, Regulatory Affairs, and external suppliers to assess and mitigate material‑related risks.
• Support technology transfers, quality investigations, supplier assessments, and regulatory submissions.
• Communicate analytical findings, technical risks, and recommendations to scientific and business stakeholders.
• Collaborate with suppliers to improve raw material quality, consistency, transparency, and supply reliability.

• Support regulatory filings, inspections, and agency responses through scientific assessments and analytical data packages.
• Ensure analytical methodologies align with GMP requirements and current regulatory expectations.
• Contribute to raw material control strategies consistent with ICH Q8, Quality by Design (QbD), and risk‑based manufacturing principles.

• Bachelor's, Master's, or Ph.D. in Analytical Chemistry, Chemistry,…