Contract Manager / Sr Manager CMC Quality Control (QC)
Join our dynamic team as a QC Manager to support external contract organization activities, ensuring all GMP QC testing needs are met efficiently. Provide crucial internal support to CMC Operations to aid in the development, manufacture, and release of materials. This includes method transfer, qualification, validation, and managing product shelf life. Collaborate closely with PDAS, Manufacturing, CROs for technical transfer of testing methods and assays, and troubleshoot as necessary. Ensure strict compliance with regulatory standards including FDA, EMA, and other agencies. Develop and validate analytical methods for QC testing, implement quality systems for data integrity, manage release/stability data, and generate reports. Work within multiple departments to address QC document reviews and manage documentation through eQMS systems like ZenQMS. Track stability time points, create and update tables for stability data, and manage change controls, deviations, and CAPA within eQMS.
Hard Skills
- mRNA
- LNP
- Microbiology
- Stability Testing
- Biologics
- CMC
Soft Skills
- Collaboration
- Troubleshooting
- Regulatory Compliance
- Quality Assurance
- Documentation Management
Job Type
This is a contract position with a duration of 9 Month(s).
Work Site
This is a fully on-site position in Lexington, Massachusetts.
Additional Skills & Qualifications
- Bachelor's Degree in Biochemistry, Molecular Biology, Pharmaceutical Sciences or a related Life Science field with 5-8 yrs experience within the biotech/pharma industries
- 3+ years of Analytical / Quality Control experience in a GMP environment
- Good understanding of cGMPs, ICH stability, and Regulatory Drug requirements
Work Environment
The position requires initial onsite presence for 30-40 hours weekly to become acquainted with the project, followed by a potential reduction to 20 hours. A hybrid work schedule is supported, offering flexibility in working hours.
Job Type: Full-time
Pay: $60.00 - $65.00 per hour
Expected hours: 40 per week
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
Work Location: In person