- Collaborates with Process Development, Manufacturing, Analytical Development, Quality and Clinical operations to ensure successful completion of technology transfer and transfer of process improvements to TScan's internal and external manufacturing facility.
- Performs risk assessment and mitigation during product technology transfer and manufacturing.
- Performs hands on laboratory training with manufacturing staff and serves as the manufacturing process SME during technical transfer and GMP manufacturing.
- Develops and executes development studies in support of new equipment, products, and processes.
- Develops and reviews manufacturing process description, master production records and process performance qualification/process validation protocols.
- Utilizes manufacturing process knowledge and investigation skill sets to troubleshoot, identify and resolve manufacturing issues, improve process unit operations and affect positive change.
- Regularly provides progress reports, technical reports, and other status updates to the CMC and Technical Operations leadership teams.
- Practices and promotes safe work habits and adheres to TScan's safety procedures and guidelines.
- Advanced degree (BS, MS or PhD) in Chemical/Biochemical Engineering, Biochemistry, Immunology, or related degree with experience (8+ for BS, 5+ for MS, 2+ for PhD) in process development and manufacturing sciences in cell therapy, biotechnology, or pharmaceutical industry
- 3+ years Industry experience with process development, manufacturing process technical transfer, risk assessments, technical operations, and quality systems interfacing a GMP environment.
- Lab-based experience with aseptic processing, cell culture, cell therapy manufacturing and cell isolation.
- Working knowledge of GMP equipment, analytical testing, such as flow cytometry and cell counting analytics is preferred.
- Knowledge of Immunology or Immune-oncology, especially T cell biology is desired.
- Knowledge of GMP regulations and ICH/quality guidelines related to cell therapy manufacturing.
- Excellent communication and interpersonal skills.
- Highly organized with immense attention to detail.
- Demonstrated effective collaboration and communication with laboratory and manufacturing staff.
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Scientist/Process Engineer, Manufacturing Sciences - Waltham, United States - TScan Therapeutics
Description
Position Summary:TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for an experienced Scientist or Process Engineer to join our Manufacturing Science team, supporting TScan's cell therapy manufacturing process development and GMP production of clinical cell therapy candidates. The ideal candidate should have relevant experience in cell therapy process development, technology transfer to GMP manufacturing and GMP principles related to cell therapy, and enjoy fast-paced, collaborative and vibrant startup culture. A team player with a sense of urgency will thrive in this role.
Role Overview and Responsibilities:
As a subject matter expert (SME), this position will be responsible for manufacturing science efforts supporting TScan's internal and external technology transfers and manufacturing process. This role helps develop and implement manufacturing process improvements, provide technical advice during manufacturing, support manufacturing investigations and risk assessment, and mitigate process risks. This position will collaborate closely with the process development, analytical development, supply chain, project management and manufacturing teams to ensure process implementation to commercial manufacturing following project timeline and TScan's goals.
The successful candidate will have experience in at-scale cell therapy process development, GMP cell therapy manufacturing, and be able to work highly independently in a fast-paced environment. Proven excellence in technical problem solving, project management, attention to detail, and communication is a must.
Responsibilities
TScan Therapeutics was founded in 2018 by a small group of scientists led by Dr. Stephen Elledge (Harvard Medical School/HHMI). TScan is discovering and developing novel TCR-engineered T cell therapies for the treatment of cancer. TScan's discovery platform is centered around a breakthrough technology that enables the rapid, comprehensive, and genome-wide identification of the peptide antigen targets of T cell receptors. This technology greatly enhances our ability to understand the specific antigens that drive important disease processes, including tumor cell recognition by the immune system, self-reactivity in autoimmune disorders, and acquired immunity in infectious disease. TScan is using the platform in oncology to discover new TCR/target pairs and to rapidly move novel TCRs into clinical development.
Do YOU have the anatomy of a TScanner?
Our talented, compassionate, and intelligent team is what makes TScan a great place to work. Our brand-new offices with approximately 40,000 square feet of premium lab, manufacturing and office space is an environment that supports innovation, camaraderie and professionalism. We are driven, passionate, fun, flexible and team oriented. Sound like you? Apply today.
