Laboratory Investigation Specialist, Cell and Gene Therapy GMP Operations
The Laboratory Investigation Specialist for Cell and Gene Therapy GMP Operations will be responsible for ensuring that non-conformances identified within CBM Testing laboratories are promptly and appropriately investigated with respect to the determination of root cause, impact assessment and CAPAs. Responsible for leading the coordination of OOT, OOS, deviations and investigations related to assays and processes related to the testing of cell and gene therapy products and training staff, when needed, on root cause analysis tools and technical writing.
- Author, track monitor, facilitate closure, and QA review of investigations, out of specification (OOS) and out of trend (OOT) reports for compliance to FDA regulations and other guides/guidelines.
- Using root cause determination techniques, perform Non-Conformance, Deviation, OOS, and OOT investigations to determine the root cause and effective corrective / preventive action (CAPA) implementation to prevent recurrence of the event.
- Interact with clients in the performance of investigation duties.
- Experience performing, reviewing and issues associated with biological laboratory testing (i.e. Flow cytometry, ELISA, PCR, HPLC, Cell based assays, Virus testing, etc).
- Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines.
- Provide cGMP guidance to functional groups such that all non-conformances are closed within defined timeframes and product release dates.
- Build and foster relationships across the technical operations groups, Analytical Development Departments, contributing to projects and peer review when required
- Fostering a culture of scientific rigor and continuous improvement in line with the Innovation Performance and Trust strategy at The Center for Breakthrough Medicines
- Ensure compliance with The Center for Breakthrough Medicines values and policies
- Evaluate risks and opportunities with Sr. Management and drive strategic outcomes for the business.
- Ensure quality and assists Quality Assurance in maintaining all technical and regulatory requirements.
- Where required, and in partnership with QA/Regulatory Affairs, meet with relevant Regulatory Bodies to resolve any compliance issues or help with any new business requirements that potentially impact the accreditation or compliance status.
- Perform all other related duties as assigned by the Head of Testing Operations.
- Bachelor’s degree with major in Biological Sciences or similar major and 6 years of laboratory and root cause analysis experience related to laboratory investigations.
- Master’s degree with major in Biological Sciences or similar major and 3 years of laboratory and root cause analysis experience related to laboratory investigations.
- Doctorate degree with major in Biological Sciences or similar major and 2+ years of laboratory and root cause analysis experience related to laboratory investigations.
- Experience in an FDA regulated biotechnology laboratory.
- Independent, self-motivated and innovative and the ability to excel in a goal-oriented, multifaceted and fast-moving team environment are required.
- Capable of multi-tasking but with attention to detail, working on multiple projects, while delivering on objectives.