Senior Specialist, Raw Material Analytical Characterization

Job Description Position Summary 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. Key Responsibilities Raw Material Characterization & Risk Assessment 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. Analytical Characterization 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. Cross-Functional & External Collaboration 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. Regulatory & Compliance Support 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. Education and Experience Bachelor’s, Master’s, or Ph.D. in Analytical Chemistry, Chemistry, Biochemistry, Chemical Engineering, Materials Science, Pharmaceutical Sciences, Biological Sciences, or a related scientific discipline. Bachelor’s degree with 6+ years of relevant experience; OR Master’s degree with 4+ years of relevant experience; OR Ph.D. with no industry experience. Relevant experience may include biopharmaceutical, biotechnology, analytical sciences, materials characterization, process development, manufacturing support, or quality operations. Required Skills Expertise in analytical chemistry, materials characterization, or biophysical characterization. Experience developing and applying analytical methods to characterize complex materials and sources of variability. Understanding of raw material variability and its impact on bioprocess performance and product quality. Strong scientific problem-solving, data interpretation, and investigation skills. Proven ability to lead scientific projects and collaborate across cross-functional teams. Preferred Skills Experience with biologics manufacturing, cell culture, fermentation, purification, or aseptic processing. Understanding of chemically defined media and feed systems and their impact on cell performance and product quality. Experience characterizing impurities and trace-level contaminants affecting process performance or product quality. Expertise in chromatographic and mass spectrometry techniques, including HPLC, UPLC, UHPLC, LC-MS, LC-MS/MS, GC-MS, ICP-MS, and related methodologies . Experience with cell-based assays, amino acid/vitamin analysis, particle characterization, microscopy, thermal analysis, or other advanced characterization techniques. Experience using analytical data to support supplier qualification, raw material risk assessments, and supply chain optimization. Familiarity with PAT, automation, digital tools, and data analytics. Experience working with suppliers and external laboratories to improve raw material quality and consistency. Key Competencies Adaptability, Adaptability, Analytical Thinking, Bioprocess Understanding, Bioreactors, Cell Cultures, cGMP Regulations, Chemical Engineering, Chromatographic Techniques, Clinical Judgment, Cross-Functional Collaboration, Materials Characterization, Risk Analysis, Risk Assessments, Risk Control Assessment, Stakeholder Communications, Stakeholder Engagement Required Skills: Analytical Chemistry, Analytical Tools, Biologics, Characterization Techniques, Cross-Functional Project Management, Data Analysis Tools, Liquid Chromatography (LC), Liquid Chromatography-Mass Spectrometry (LC-MS), Pharmaceutical Sciences, Raw Material Analysis, Raw Material Sourcing, Regulatory Compliance, Technical Transfer, Technology Transfer Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommoda