Senior Manager, Quality Control
EGenesis
Administration, Quality Assurance
Cambridge, MA, USA
Posted on Feb 5, 2025
COMPANY MISSION
At eGenesis, we aspire to deliver safe and effective human transplantable cells, tissue and organs utilizing the latest advancements in genome editing.
POSITION SUMMARY
The Senior Manager, Quality Control (QC) will be responsible for leading the Quality Control unit. The ideal candidate will demonstrate strong leadership capabilities and communication skills across CMC functions. You will lead the development, planning, implementation, and maintenance of QC activities, which include method transfer and qualification, troubleshooting, and release and stability testing of our innovative drug substance and products. You will ensure activities are executed in a cGMP compliant manner and oversee the build-out of QC as eGenesis expands clinical capabilities. The ideal candidate will be highly motivated, excited by technical challenges, and work well in a team environment. This is a people management role and requires the ability and skills to manage analysts, including supervising routine activities, managing performance, and creating and supporting development plans. This role will report to the Senior Director, Analytical Development and Quality Control.
PRIMARY RESPONSIBILITIES
- Oversee the execution of QC activities to support release and stability testing for drug substance and drug product
- Lead the transfer, qualification, and maintenance of QC test methods, processes, equipment, and procedures in support of our pre-clinical and clinical programs
- Manage method qualification and release testing conducted at contract testing organizations
- Hire and on-board QC personnel per recruitment plan
- Implement QC systems and procedures compliant with cGMP
- Oversee laboratory investigations, Out of Specification (OOS) and Out of Trend (OOT) results as well as Change Controls and Corrective/Preventive Actions as required
- Manage programs for critical laboratory reagents, assay controls/reference standard, and equipment
- Represent the QC function at cross-functional meetings, including but not limited to CMC and program team meetings
- Author/collaborate in the compilation of data and reports in support of regulatory submissions
- Maintain the QC Unit in a state of compliance and inspection readiness
BASIC QUALIFICATIONS
- BS/MS in biology, immunology, biochemistry or a related scientific discipline with 8+ years industry experience
- Expertise in Cell Therapy/Gene Editing Analytical Methods ranging from molecular biology, cell biology, flow cytometry, biochemical, and biophysical assays
- In-depth knowledge of FDA/EMA/ICH regulations and guidelines; pertaining particularly to Cell Therapy/Gene Editing product development platforms
- QC managerial experience is required
- Detail oriented, organized, and proactive with the ability to work in a fast-paced environment
- Demonstrated strong technical writing with experience authoring QC content in regulatory submissions
- Effective communication skills, both verbal and written, across various functions including Manufacturing, Quality Assurance, and Analytical Development