Senior Scientist, Product Sciences
1 week ago
Affini-T Therapeutics is announcing a Scientist II/Senior Scientist opportunity at our headquarters in Watertown, MA.
Position SummaryThe Scientist II/Senior Scientist will be a key member of the Product Sciences Group (Analytical Development) in CMC and will work in a matrix setting interacting with other functions in CMC, QA, Reg Affairs, R&D, Translational and Clinical team members.
The individual will be involved in technical oversight of analytical activities with internal and external partners (CDMOs, Analytical Contract Labs) and will assist in analytical technology transfers for Drug Product TCR candidates, including critical intermediates such as LVV and non-viral vectors and gene editing reagents. The Scientist II/Senior Scientist will assist in establishing specifications, product comparability studies and providing support in the preparation of regulatory submissions and health authority interactions. The individual will also be responsible for managing and coordinating analytical activities in support of manufacturing process development, IND enabling studies and clinical material characterization. The individual may be involved in laboratory activities to support this effort.
The ideal candidate will have experience working with Quality Assurance and must have a high level of independence to carry out their responsibilities with minimal supervision. This is a unique opportunity to shape the CMC team and roadmap to product licensure at a small and rapidly growing biotechnology company.
Essential Duties and ResponsibilitiesThe major tasks for this position are as follows:
- Manage and execute clinical research activities for multiple trials.
- Assist in Analytical Technology Transfer activities to contractors and provide technical assistance and supervision during routine QC / Manufacturing activities.
- Assist in resolution of quality events (laboratory investigations, deviations, change controls, CAPAs, risk assessments, impact assessments, out-of-specification (OOS)).
- Assist in the development and elaboration of phase appropriate method validation protocols, used for release and characterization.
- Contribute to regulatory filings such as IND and BLA.
- Establish processes, manage, and coordinate extended characterization testing of clinical product lots at Affini-T.
- Serve as a liaison between Analytical Development and Process Development teams to coordinate and perform analytical testing in support of process and product characterization and understanding.
- Develop and maintain analytical tracking and trending tools and systems to monitor product quality (QC release, in process data and characterization) stability, and method performance.
Desired and Required QualificationsEducation and Experience:
- Bachelors +9, Masters +6, PhD +4 in Biochemistry, Biology, or related field experience in the biotechnology/pharmaceutical industry with increasing responsibility in analytical development or quality control, or equivalent combination of education and experience.
- Extensive hands-on experience spanning analytical development of biologics and cell therapies (e.g., flow cytometry, cell-based assays, PCR, HPLC, CE etc.).
- Track record of successful analytical technology transfers and GMP manufacturing of clinical trial material.
- Excellent working knowledge of GMP and GLP requirements.
- Must have a good understanding of Quality Systems and demonstrate proficiency in the application of QA principles, concepts, industry practices, and standards. Good conceptual, strategic, analytical, problem solving, and organizational skills.
- Autonomous, take-charge, proven team player with a strong results orientation, positive “can do” attitude, and a sense of urgency to get things done.
- High emotional intelligence, sound temperament and professional attitude.
- Excellent communication skills, both verbal and written, and the ability to interface effectively with all levels of the organization. Strong communication skills with outside contract organizations are required.
- Results and detail-oriented; self-motivated, ability to work with minimal supervision.
- Personal alignment with Affini-T’s values, mission, and vision.
- Sit for extended periods of time (2 or more hours)
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