Director of Operations

Director, GMP Laboratory OperationsGeneral SummaryThe Director owns day-to-day operation of a GMP service laboratory and is accountable for its compliance. This person turns client orders into on-time, validated, audit-ready results. The role combines hands-on expertise in microfluidics and human cell culture with the quality, data, and regulatory discipline biopharma clients expect from a GMP testing provider whose data will appear in their regulatory filings. The Director also delivers excellent customer service by gathering client feedback and resolving issues promptly.Major Duties and ResponsibilitiesRegulatory compliance: Own GMP compliance for the laboratory. Work with the quality unit to build and maintain the quality system: SOPs, training records, equipment qualification (IQ/OQ/PQ), deviations, OOS investigations, CAPA, and change control. Host client audits and regulatory inspections.Service delivery: Run the lab end to end, from sample receipt and chain of custody through testing, data review, and release of results, within agreed turnaround times.Client interface: Act as the senior technical contact for clients. Lead study kickoffs, present results, resolve questions and complaints, and agree technical scope with Business Development.Report writing: Write and approve validation master plans, validation reports, study reports, and regulatory-ready data packages. Sign off on every client report before release.LIMS and data management: Select, configure, validate, and administer the LIMS, including the client results workflow and the pipeline for large imaging and video files. Make sure results are entered, reviewed, approved, and released under 21 CFR Part 11 controls.Validation: Own assay qualification and validation for all lab readouts, including video potency, off-target binding, activation and exhaustion markers, CRS risk markers, adhesion markers, immunogenicity, cytokine multiplex, metabolites, and NGS. Follow ICH Q2(R2) and FDA potency guidance for CGT products.Regulatory filings: Write and review technical sections for client IND and BLA filings, and support client meetings with FDA when the lab’s data is under discussion.Capacity and confidentiality: Forecast and schedule the organ-on-chip devices, instruments, and staff needed for concurrent studies. Protect client IP through CDAs, segregated data access, and blinded sample handling.People leadership: Train and develop the scientific team, set goals, run performance reviews, and build a safe BSL-2, compliance-first culture.Business partnership: Support Business Development on SOWs, quality agreements, study design, and cost inputs. Own the lab operating budget.Other duties as assigned.EducationPhD in bioengineering, biomedical engineering, cell biology, immunology, or a related field. A combination of education, training, and directly related experience may be considered as an equivalent.LicensesValid U.S. driver’s license.Required Experience8+ years of post-PhD experience, or 12+ years with a Master’s degree.4+ years managing scientists.Hands-on work in microfluidics or organ-on-chip systems with human primary cells (e.g., T cells, PBMCs, endothelial or epithelial cells).Leadership in a GMP laboratory, including hosting audits or inspections.Assay qualification and validation, including written plans and reports you authored.Implementing or administering a LIMS or ELN and managing regulated data.Contributing to regulatory filings (IND, BLA, or equivalent), such as CMC or nonclinical sections.Candidates should bring examples of: (1) a microfluidic human cell assay built or run at scale; (2) a validation plan or report they wrote; (3) a LIMS or data system they implemented; (4) a GMP audit or inspection they hosted or supported; and (5) a regulatory filing they contributed to, with their role described. Confidential details may be redacted.Preferred ExperienceLeading a fee-for-service, CRO, or core lab with external clients and turnaround commitments.Potency assays for CAR-T/CAR-NK, TCR-T, NK cells, EVs/exosomes, small molecules, peptides, or gene therapy.Live-cell imaging and image analysis pipelines, flow cytometry, and multiplex cytokine platforms.Engaging with FDA on New Approach Methodologies (NAMs) or MPS data.Working knowledge of 21 CFR Parts 210/211 and Part 11 and of data integrity expectations; GLP (21 CFR Part 58) is a plus.SkillsClear, confident communication with clients and strong technical writing.