Associate Director, Manufacturing Operations (50% travel)

Responsibilities:

• Provide operational expertise to ensure routine successful manufacturing of allogeneic CAR T process
• Provide oversight in order to make strategic decisions to further Adicet’s activities at CMO.
• Act as person in plant at CMO as technical subject matter expert for GMP manufacture of CAR T cell products including equipment troubleshooting of bioprocess equipment
• Manage manufacturing, QC, and QA related functions to ensure successful release of GMP products which may include providing expertise and guidance to support change control and deviation closure
• Ensure that executed batch record and analytical documentation is reviewed in a timely manner to support rapid lot disposition
• Liaise with senior management at Adicet regarding progress at CMO
• Author batch record updates via change controls as needed based on experience and observations during PIP activities.
• Educate and develop training program for manufacturing personnel to perform process and be able to address unexpected errors
• Support root cause analysis and impact assessments for deviations
• Oversee materials management and authorize orders of materials and equipment needed to ensure success of manufacturing campaign.

Qualifications:

• MS/PhD in Biochemical Engineering, Chemical Engineering, or Biotechnology.
• MS with 12 years’ experience in industry setting or PhD with 8 years in industry setting.
• Commitment to travel – this position will require an initial training/onboarding period of up to 3 months at Adicet’s facility in Redwood City, CA. It is preferred that the position be permanently based in the Midwest/Southern United States, but otherwise, at least 50% travel to the CMO is expected
• A strong background in cell therapy products or CAR T products required.
• Experience with GMP manufacturing for cell therapy products and tech transfer related activities
• Expertise in aseptic technique, cell culture, and viral transductions
• Expertise in bioprocess equipment such as Sefia, LOVO, Rotea, Sepax, CliniMACS, and bioreactors.
• Possesses excellent verbal and written communication skills.
• Ability to operate in a fast paced, industrial environment.

Benefits

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 12 company holidays with end-of-year shutdown, vacation, sick time, and paid parental leave.