Sr. Engineer, Process Development

Role: Senior Process Engineer focused on chemical process development, scale-up, and technology transfer for biopharmaceutical manufacturing. Responsibilities include executing lab and pilot experiments, designing and optimizing synthetic and hybrid processes, evaluating novel chemistries, developing process models, and authoring technical and regulatory documentation. The role entails supporting commercialization activities, risk assessments, process validation, and troubleshooting manufacturing issues, ensuring compliance with cGMP standards. Collaboration involves cross-functional teams including process development, analytical chemistry, and manufacturing support, with up to 20% domestic and international travel. Qualifications: Doctorate or Master's with 2+ years, Bachelor's with 4+ years, or equivalent experience in chemical engineering or related fields. Preferred expertise in bioprocessing unit operations relevant to ADCs or oligonucleotides, process modeling platforms, analytical techniques (HPLC, MS, NMR), and regulatory documentation (CMC modules). Experience supporting regulated environments, process scale-up, and process validation is advantageous. The position is based in Cambridge, MA or Thousand Oaks, CA, with hybrid work arrangements.