What are the responsibilities and job description for the Manufacturing Associate 2/3 – Cell Therapy position at Adicet Bio?
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Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of "off-the-shelf" gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. For more information, please visit our website at https://www.adicetbio.com.
Manufacturing Associate 2/3 – Cell Therapy
We are seeking a highly motivated and experienced individual with a strong background in cell process development/manufacturing. The Manufacturing Associate 2/3 will report to the Director of Manufacturing. In this role you will support the daily manufacturing operations of allogeneic CAR T cell therapies, assist with troubleshooting complex and non-routine equipment events, initiate and support deviations, and author SOPs. You will implement Good Manufacturing Practices and best practices to streamline manufacturing operations.
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. 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.
Key responsibilities:
- Participate in the execution of cellular drug product manufacturing according to defined SOPs and manufacturing batch records within a cleanroom environment as performer or verifier
- Operate and troubleshoot bioprocess equipment such as Sepax, LOVO, CliniMACS, 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
- Execute equipment qualifications as per approved PQ protocols
- Perform environmental and personnel monitoring as needed
- Troubleshoot OOE and OOT issues during routine manufacturing
- 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 1-3 years of experience in a clinical processing and/or cell culture operations preferably in a GMP environment; or equivalent combination of education and experience.
- 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 therapy or CAR-T products preferred
- 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 fosters a collaborative, high-performing environment by prioritizing in-person engagement. To enhance teamwork and communication, employees are required to be onsite at least three days per week (Tuesday–Thursday mandatory), with some roles requiring full-time onsite presence.
At Adicet, our people are our greatest focus. We believe that attracting and retaining the best and brightest is the key to achieving our mission to deliver best-in-class gamma delta T cell therapies for patients fighting autoimmune diseases and cancer.
We offer a competitive compensation package including base salary, annual cash bonus, long-term incentives (equity), Employee Stock Purchase Plan (ESPP) and a 401(k) with ROTH and a 4.5% Company match.
To ensure the wellness of our employees and their loved ones, we offer comprehensive health plans (medical, dental, vision, etc.), Flexible Health and Commuter Spending Accounts (FSA) and a company matched Health Savings Account (HSA). We also offer a life, AD&D, short and long-term disability insurance, and legal, pet, and various other voluntary insurance programs.
We also believe our greatest ideas come when we are refreshed and focused, and we offer generous paid time-off including 13 company holidays, paid end-of-year winter break, vacation, sick time, and paid parental leave.
Adicet is located in a state-of-the-art facility and works to create an incredible office experience with an onsite gym and various other fitness options, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company-subsidized lunches (delivered onsite daily) and fully stocked breakrooms.
Adicet 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.
