QC Specialist
Regeneron
4 hours ago
On-site
Cambridge, MA
Operations
QC Specialist (Phase 1 GMP Testing Laboratory)
Responsibilities:
- Support Phase 1 GMP testing for release and stability across multiple stages of cell and gene therapy products, including performing analytical methods, data review, and data trending.
- Support continuous improvement of GMP systems to ensure a compliant Quality Control lab.
- Interface with Analytical Development and Method Validation to support successful method transfer, and collaborate with Quality Assurance, IT, Facilities, and other cross-functional teams.
- Perform cGMP analytical testing (bioassay, cell culture, flow cytometry, qPCR, ELISA).
- Review and evaluate raw data at peer-review level.
- Author SOPs/FORMs and technical reports (with guidance).
- Initiate laboratory deviations and support investigations (IA, OOS, AR), including assessment, protocol/report authoring, and investigation closure (with guidance).
- Author, review, and execute equipment validations (with guidance).
- Support operational systems: maintenance/calibration, alarm monitoring, sample handling/tracking, data integrity/control, cGMP documentation, LIMS, laboratory audits, and method training.
- Execute phase-appropriate test method validation protocols, as needed.
- Provide information to support regulatory filings and inspections.
- Support CAPA/continuous improvement initiatives.
- Be flexible to support shift work, as needed.
Qualifications:
- BS in Biotechnology.
- 2+ years of experience in a cGMP/GxP environment.
- Hands-on experience with cell culture, flow cytometry, quantitative PCR, and other bioanalytical methods (e.g., ELISA).
- Superb organizational, analytical, and communication skills; “do-what-it-takes” attitude.
- Strong ability to learn and adapt to change.
- Self-directed; able to work with limited direction in a fast-paced, goal-oriented environment.
Application Instructions:
- Apply now to be considered for the role.
Responsibilities:
- Support Phase 1 GMP testing for release and stability across multiple stages of cell and gene therapy products, including performing analytical methods, data review, and data trending.
- Support continuous improvement of GMP systems to ensure a compliant Quality Control lab.
- Interface with Analytical Development and Method Validation to support successful method transfer, and collaborate with Quality Assurance, IT, Facilities, and other cross-functional teams.
- Perform cGMP analytical testing (bioassay, cell culture, flow cytometry, qPCR, ELISA).
- Review and evaluate raw data at peer-review level.
- Author SOPs/FORMs and technical reports (with guidance).
- Initiate laboratory deviations and support investigations (IA, OOS, AR), including assessment, protocol/report authoring, and investigation closure (with guidance).
- Author, review, and execute equipment validations (with guidance).
- Support operational systems: maintenance/calibration, alarm monitoring, sample handling/tracking, data integrity/control, cGMP documentation, LIMS, laboratory audits, and method training.
- Execute phase-appropriate test method validation protocols, as needed.
- Provide information to support regulatory filings and inspections.
- Support CAPA/continuous improvement initiatives.
- Be flexible to support shift work, as needed.
Qualifications:
- BS in Biotechnology.
- 2+ years of experience in a cGMP/GxP environment.
- Hands-on experience with cell culture, flow cytometry, quantitative PCR, and other bioanalytical methods (e.g., ELISA).
- Superb organizational, analytical, and communication skills; “do-what-it-takes” attitude.
- Strong ability to learn and adapt to change.
- Self-directed; able to work with limited direction in a fast-paced, goal-oriented environment.
Application Instructions:
- Apply now to be considered for the role.