Associate Director, Manufacturing Technology - United States
- Our company is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care.
- The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors.
- our company is seeking a highly-motivated individual with cell culture and drug product experience to work on innovative T cell therapy for cancer treatment.
- The Associate Director, Manufacturing Technical Services will manage technical team responsible for deviations, CAPAs, change control and front line support for our company’s commercial manufacturing site producing autologous T cell therapy products.
- Lead the technical team responsible for deviations, CAPAs, change control and front line support
- Investigate, identify root cause for critical deviations and determine CAPA for manufacturing
- Establish data analytics to serve as metrics
- Support incoming tech transfers from Product Sciences
- Author technical reports and protocols in support of cGMP activities
- In collaboration with Product Science evaluate and implement continuous improvement initiatives
- Masters/Ph.D in Biochemistry, Chemical Engineering, Biotechnology or equivalent
- Expertise with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
- Mastery of scientific and engineering principles
- Practical experience in GMP operations
- Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products, and process development
- Ability to think critically, and demonstrated troubleshooting and problem solving skills
- Excellent interpersonal, verbal and written communication skills
- Ability to function efficiently and independently in a changing environment
- Self-motivated and willing to accept temporary responsibilities outside of initial job description
- Well-developed computer skills
- Must have 10+ years of pharmaceutical manufacturing, technology transfer or process development experience
- Pharmaceutical products GMP manufacturing experience is a must
- Cell culture or aseptic processing experience is a plus
- Previous experience with cell therapy products is a plus
- Equipment qualification experience in a cGMP environment (IQ, OQ, PQ) is preferred; process validation experience is a plus
- Proven track record of leading and managing cross functional teams
- Knowledge of data management tools and statistical process controls
- Our company is an equal opportunity employer.
- We are able to offer the opportunity to be part this successful, fast growing company. A place everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commensurate to any large corporation.