Senior Manufacturing Associate - Viral Vector

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Adicet Bio, Inc is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer. We are advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CAR) and T cell receptor-like antibodies (TCRL), to enhance selective tumor targeting, facilitate innate and adaptive anti-tumor immune response, and improve persistence for durable activity in patients. Our approach to activate, engineer and manufacture allogeneic gamma delta T cell product candidates derived from the peripheral blood cells of unrelated donors allows us to generate new product candidates in a rapid and cost-efficient manner. For more information, please visit our website at http://www.adicetbio.com.

Senior Manufacturing Associate - Viral Vector

We are seeking a highly motivated and experienced individual with a strong background in viral vector development/manufacturing. The Senior Manufacturing Associate will report to the Director of Manufacturing. In this role you will serve as the lead to support the daily manufacturing operations of allogeneic CAR T cell therapies, troubleshoot complex and non-routine equipment events, initiate and assess deviations, review batch records, and author SOPs. You will implement Good Manufacturing Practices and best practices to streamline manufacturing operations. The Supervisor will have direct reports and be instrumental in leading the team to meet department and company goals.

You will demonstrate expertise and breadth of knowledge in executing processes across a variety of production activities such as cell processing, aseptic behavior, monitoring equipment and processes, product sampling, and conducting routine sanitization tasks to maintain facility and equipment as well as supervise and train other operators on these tasks. You will read and follow defined SOPs and policies, work independently on basic manufacturing tasks, identify and communicate non-routine events, and review more complex decisions with your direct supervisor.

Responsibilities:

• Oversee and participate in the execution of viral vector manufacturing according to defined SOPs and manufacturing batch records within a cleanroom environment
• Oversee direct reports to ensure department and corporate goals are met.
• Operate and troubleshoot process equipment such as TFF skids, incubators, functionally closed system bioreactors, and controlled rate freezers
• With Quality Assurance, supervisor, and Facilities, ensure preparedness for runs in terms of equipment readiness and operator training
• Troubleshoot OOE and OOT issues during routine manufacturing
• Manage, provide guidance, and support a team of manufacturing associates
• Collaborate with MS&T to refine MBRs and with SCM to generate supply orders to support BOM
• Must possess high degree of learning agility
• Support Quality Management system including but not limited to deviation investigations and risk assessments
• Understand and implement safety procedures.

Qualifications:

• Bachelor’s degree in a biological science, engineering or related science discipline with 3 – 5 years of experience in a clinical processing and/or cell culture operations preferably in a GMP environment; or equivalent combination of education and experience.
• Supervisor or lead operator for 1 – 2 years.
• GMP experience in a cleanroom for cell therapy products required with previous experience in gown qualification, aseptic behavior, materials kitting, and aseptic flow of materials
• A strong background in cell culture or purification
• Working knowledge and understanding of GMP, GCP, GDP, and relevant FDA guidelines.
• Process-oriented with strong analytical skills for risk identification and management.
• Excellent verbal and written communication skills and can confidently communicate with all levels of staff in this collaborative work environment.
• Self-motivated and comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
• Proficient in MS word, Excel, PowerPoint, Outlook and warehouse management software.

Adicet Bio requires all workers to be fully vaccinated against COVID-19, including the booster dose.

Benefits:

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.