We are seeking a highly motivated Process Development Scientist with strong expertise in protein purification and biochemical analysis to join our Technical Operations team. This role will support the development and manufacture of HPV Gardasil and other biologics through upstream and downstream processing, analytical characterization, and process optimization. The ideal candidate will work both independently and as part of a multidisciplinary team to support lab- and pilot-scale operations using a variety of fermentation and purification techniques. Pay Range - $36 - $43 an hr. Key Responsibilities: Design, execute, and troubleshoot lab- and pilot-scale fermentation and purification experiments for proteins, VLPs (virus-like particles), and other biologics. Characterize proteins, VLPs, and related components using a range of biochemical and analytical methods. Operate and optimize AKTA chromatography systems and tangential flow filtration (TFF) units for downstream processing. Author technical documentation, including laboratory notebooks, protocols, reports, and SOPs. Support process characterization studies, manufacturing investigations, and technology transfer activities. Maintain accurate lab records and ensure compliance with GMP, GLP, and internal quality standards. Collaborate cross-functionally with QA, Manufacturing, and Engineering to ensure process continuity. Employ excellent data interpretation and technical problem-solving skills to deliver high-quality scientific output. Contribute to continuous improvement initiatives (e.g., Six Sigma, 5S principles). Uphold good laboratory practices and sample handling procedures. Contribute to a diverse and inclusive team environment, and meet tight project timelines and priorities. Required Qualifications: Education: Bachelor's degree in Biochemistry, Chemistry, Biology, Life Sciences, or Engineering with 4+ years of relevant experience Master's degree with 2+ years of relevant experience Ph.D. with direct relevant experience Experience and Skills: Hands-on experience with protein purification from bacterial, yeast, or mammalian systems at lab or commercial scale. Proficiency in AKTA chromatography systems and Unicorn software. Solid foundation in protein biochemistry, wet chemistry, and analytical characterization. Skilled in buffer prep, filtration, dilution, stoichiometry, and general wet-lab techniques. Proficient in technical writing, lab notebooks, and data management systems. Strong teamwork, collaboration, and communication skills. Preferred Qualifications: Experience with: Column chromatography, ultrafiltration/microfiltration (TFF) Yeast fermentation and metabolism Fermentation or cell culture using shake flasks or bioreactors Material characterization, working with enzymes and peptides GMP/GLP environments, facility and laboratory operations Process development, method development, and transfer Industry experience in biotech or pharmaceutical settings Technical issue troubleshooting (equipment, experimental, data) Familiarity with Six Sigma, 5S, and lean manufacturing principles PDN-9f25e099-d7e7-4c52-b203-e9a0340d1880
Job ID: 481375816
Originally Posted on: 6/15/2025
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