QC Specialist
Regeneron
5 hours ago
On-site
Cambridge, MA
Operations
QC Specialist (Cell & Gene Therapy)
Responsibilities:
- Support Phase 1 GMP testing laboratory for release and stability testing across multiple stages of cell and gene therapy products.
- Perform analytical methods; support data review and trending.
- Support continuous improvement of GMP systems to ensure a compliant Quality Control laboratory.
- Interface with Analytical Development and Method Validation to support successful method transfer.
- Author SOPs/FORMs and technical reports with guidance.
- Initiate laboratory deviations and support investigations (IA, OOS, AR), including assessment, authoring protocols/reports, and investigation closure with guidance.
- Author, review, and execute equipment validations with guidance.
- Support operational systems: equipment/instrument maintenance & calibration, equipment 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 / Required Skills:
- BS in Biotechnology.
- 2+ years experience in a cGMP/GxP environment.
- Hands-on experience with cell culture, flow cytometry, quantitative PCR, and other bioanalytical methods (e.g., ELISA).
- Strong organizational, analytical, and communications skills; “do-what-it-takes” attitude.
- Ability to learn and adapt to change.
- Self-directed; able to work with limited direction in a fast-paced, goal-oriented environment.
Benefits:
- Health and wellness programs (medical, dental, vision, life, disability), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees.
Application Instructions:
- Apply now.
Responsibilities:
- Support Phase 1 GMP testing laboratory for release and stability testing across multiple stages of cell and gene therapy products.
- Perform analytical methods; support data review and trending.
- Support continuous improvement of GMP systems to ensure a compliant Quality Control laboratory.
- Interface with Analytical Development and Method Validation to support successful method transfer.
- Author SOPs/FORMs and technical reports with guidance.
- Initiate laboratory deviations and support investigations (IA, OOS, AR), including assessment, authoring protocols/reports, and investigation closure with guidance.
- Author, review, and execute equipment validations with guidance.
- Support operational systems: equipment/instrument maintenance & calibration, equipment 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 / Required Skills:
- BS in Biotechnology.
- 2+ years experience in a cGMP/GxP environment.
- Hands-on experience with cell culture, flow cytometry, quantitative PCR, and other bioanalytical methods (e.g., ELISA).
- Strong organizational, analytical, and communications skills; “do-what-it-takes” attitude.
- Ability to learn and adapt to change.
- Self-directed; able to work with limited direction in a fast-paced, goal-oriented environment.
Benefits:
- Health and wellness programs (medical, dental, vision, life, disability), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees.
Application Instructions:
- Apply now.