Senior Specialist, Raw Material Analytical Characterization

What you'll do

• Develop characterization programs for raw materials like cell culture media, feeds, amino acids, and excipients.
• Identify and assess Critical Material Attributes (CMAs) to determine their impact on process performance and product quality.
• Investigate sources of raw material variation and evaluate the impact on cell growth, productivity, and potency.
• Develop analytical methods using advanced techniques like HPLC, LC-MS, and GC-MS to quantify impurities and contaminants.
• Implement risk-based strategies to prioritize materials based on process impact, supplier performance, and supply chain complexity.
• Collaborate with suppliers to improve raw material quality, consistency, transparency, and overall supply reliability.
• Support regulatory filings and inspections by providing scientific assessments and analytical data packages.
• Ensure all analytical methodologies align with GMP requirements and current pharmacopeial standards.

What we're looking for

• Bachelor’s degree with 6+ years of experience, Master’s with 4+ years, or Ph.D. with no industry experience in a relevant scientific field.
• Expertise in analytical chemistry, materials characterization, or biophysical characterization is required.
• Experience developing and applying analytical methods to characterize complex materials and sources of variability is required.
• Knowledge of raw material variability and its impact on bioprocess performance and product quality is required.
• Strong scientific problem-solving, data interpretation, investigation skills, and cross-functional leadership are required.
• Experience with biologics manufacturing, cell culture, fermentation, purification, or aseptic processing (preferred).
• Expertise in chromatographic and mass spectrometry techniques including HPLC, UPLC, LC-MS, and GC-MS (preferred).
• Experience with advanced characterization like cell-based assays, particle characterization, or thermal analysis (preferred).