Senior Scientist, Quality Control, Microbiology

📋 Description • Serve as the definitive microbiology authority for Orca Bio’s GMP cell-therapy facility, ensuring every batch of our high-precision investigational products meets the sterility and safety standards that give blood-cancer patients a second chance at life. • Own the design, validation, and continuous improvement of viable and non-viable environmental-monitoring (EM) programs for ISO-classified cleanrooms, production equipment, and personnel; align all protocols with USP <1116>, EU GMP Annex 1, FDA/EMA guidance, and internal risk assessments. • Lead method-development and qualification studies for rapid microbial detection, endotoxin, bioburden, sterility, and mycoplasma assays; author robust validation protocols, technical reports, and SOPs that withstand regulatory scrutiny and scale seamlessly from Phase II to commercial launch. • Interpret complex EM and utility data sets, apply statistical process-control tools, and present clear, risk-based recommendations to senior leadership; drive CAPA effectiveness and proactively prevent excursions that could delay patient dosing. • Act as the primary microbiology subject-matter expert during FDA, EMA, and partner audits; respond to agency questions in real time, defend data-integrity practices, and transform observations into sustainable compliance enhancements. • Investigate all microbiological deviations, out-of-specification results, and environmental excursions using root-cause methodologies such as fishbone diagrams, 5-Whys, and fault-tree analysis; author thorough investigation reports and mentor junior staff in sound scientific writing. • Partner cross-functionally with Manufacturing, QA, Facilities, MSAT, and Process Development to embed contamination-control strategies into facility design, equipment qualification, and batch records; influence upstream decisions that reduce microbial risk downstream. • Establish and maintain a risk-based contamination-control program that includes cleaning validation, disinfectant efficacy, personnel monitoring, and raw-material assessments; ensure strategies evolve with emerging regulatory expectations and novel therapy modalities. • Provide hands-on training, coaching, and technical guidance to QC Microbiology analysts and manufacturing operators; build a culture where every team member understands the “why” behind aseptic technique and environmental stewardship. • Champion continuous-improvement initiatives—lean lab workflows, paperless data systems, automation opportunities—that shorten testing turnaround times and free scientists to focus on higher-value investigations. • Contribute to regulatory filings (IND, IMPD, BLA) by authoring CMC sections, risk assessments, and comparability protocols that articulate microbiological control strategies and product safety. • Maintain full data-integrity compliance with ALCOA+ principles; perform periodic data reviews, laboratory audits, and training refreshers to ensure inspection readiness at all times. • Support tech-transfer of new products into the Sacramento facility by defining microbiological control points, acceptance criteria, and sampling plans that align with process capabilities and patient safety. • Participate in cross-site networks to harmonize microbiology practices, share lessons learned, and implement global standards that position Orca Bio as a leader in cell-therapy manufacturing. • Model Orca Bio’s core values—passion, courage, and integrity—by asking “why not?” and challenging the status quo in pursuit of breakthrough therapies that restore patients’ lives.