Senior Scientist, Quality Control Development
SENIOR SCIENTIST, QUALITY CONTROL DEVELOPMENT
Adicet Bio is seeking an experienced professional to work in the Quality Control (QC) and CMC Analytical Operations Department. In this position, the individual will execute activities both internally and with the company's external contract manufacturing and contract testing partners for the development, validation and implementation of analytical methods and controls to support product development and commercialization. The individual will ensure compliance with applicable regulatory and industry standards for phase appropriate development of the company's products.
- Execute activities to achieve QC and CMC-related analytical objectives.
- Perform characterization, and product attribute criticality assessments from candidate nomination through IND- and BLA -enabling activities and ultimately commercial registration.
- Review executed QC test method results and reports for product release and disposition, including the investigation and resolution of deviations, OOS and OOT observations.
- Design and execute stability assessment programs for critical / custom materials and drug products.
- Assist in Quality Metric review processes, assess data for adverse trends, develop solutions and oversee implementation.
- Execute comparability assessments in support of product life cycle management
- Collaborate with internal departments and external CTO partners to maximize the efficiency of testing workflows.
- Compile QC and CMC Analytical-related reports and submissions, ensuring compliance with all applicable regulatory guidelines.
- Compile analytical results, protocols and reports.
- Ph.D. degree in Immunology, Cell Biology, Analytical Chemistry or related field (T cell expertise preferred).
- Minimum of five years of experience in the biotechnology or pharma industry with a primary focus on QC and CMC Analytical Operations supporting the development, manufacture, distribution and delivery of cell-based therapy products, viral vectors and/or monoclonal antibodies.
- Experience with the set-up, technology transfer and execution of analytical QC methods at CMOs.
- Experience in CAR-T, gene therapy, cell therapy, flow cytometry, ligand-based assays, cell-based assays, immunoassays and compendial methods in regulated environments is a plus.
- Excellent interpersonal and strong leadership skills with the ability to influence and liaise in a cross-functional team environment.
- Expert knowledge of GMPs, comparability protocols and qualification/validation practices.
- Proficient in MS Office, Word and Excel, LIMS as well as statistical analysis software.
- Demonstrated ability to build and maintain positive and collaborative relationships with management, peers, subordinates and externally with third party contract organizations.
- Excellent written and oral communication skills with a proven track record of developing employees.
- Self-motivated and detail-oriented, with the highest integrity.
- Ability to work independently, multitask and meet deadlines in a fast-paced environment.
Adicet Bio offers both comprehensive benefits and Paid Time (PTO) plans for employees, which begin on the first day of employment, as well as the opportunity to work in a growing, dynamic environment.
Adicet Bio is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.