Cambridge, MA30+ days ago
Lead a team of 2-4 individuals supporting Phase I manufacturing of a PSC-derived pancreatic islet cell therapy product • Partner with CDMO technical team to achieve manufacturing readiness and address technical challenges • Oversee people-in-plant, manufacturing operator training, technical documentation, and process execution • Author CMC sections for regulatory filings (IND module 3) and other technical documents • Collaborate with Quality to close deviations, analyze manufacturing trends, and recommend process improvements • Lead investigations and troubleshoot process execution challenges including root cause analysis • Perform comparability studies in collaboration with Research and PD teams to assess technology transfer success • Engage in crucial conversations by providing and receiving feedback supporting the growth and development of team members • Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines • Drive curiosity, scientific rigor and excellent problem-solving skills across a fast-paced performance driven environment. • >5 year experience supporting early phase cell therapy manufacturing including technology transfers • Well versed with cGMP requirements and working in a regulated environment, including experience as person-in-plan and/or GMP operator • Knowledge of PSC culture and differentiation biology to pancreatic islets • Experience managing a team of >3 direct reports • Detail-oriented with good problem-solving, technical writing and verbal communication skills • Ability to effectively work in multidisciplinary teams, meet deadlines, and prioritize multiple projects • Aptitude for working in a self-driven, performance/results-oriented, fast-paced matrix environment.