Associate Director, Process Sciences and Engineering - United States
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- 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 experience to work on innovative T cell therapy for cancer treatment.
- As a Principal Engineer for Manufacturing Sciences and Technology you will provide process development and engineering support for technology transfers, process validations and GMP manufacturing for our company’s engineered autologous T cell therapy products.
- Additionally, you will draft and review protocols, production procedures, and process development reports, and provide technical assessment and approval for engineering and process changes as well as documentation pertaining to process development, qualification, and validation to meet regulatory requirements.
- You will work with the Product Sciences team to design and scale-out cell therapy processes, manage equipment qualification and support process validation, as well as draft documentation for regulatory filings to advance our company’s product portfolio.
- Lead process related deviations and provide technical support to manufacturing
- Investigate, identify root cause for critical deviations and determine CAPA for manufacturing
- Write product impact assessments to support deviations
- Act as technical expert to train and supervise process technicians
- Write and review technical documentation (batch records, SOPs, protocols & reports for FATs, SATs, IQ/OQ/PQ testing, and validation testing)
- Participate and report to a cross-functional development team to advance production activities
- Ensure successful manufacturing production runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues
- Design and execute process development studies to develop a thorough understanding of operating and performance parameters
- Other duties as assigned
- Degree in Biochemical Engineering, Chemical Engineering, Biotechnology or related discipline with at least 5 years of pharmaceutical manufacturing, technology transfer & process development experience required (preferably a PhD)
- Practical expertise with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
- Mastery of scientific and engineering principles
- 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 5+ 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
- Understands and employs principles and concepts of Lean Six Sigma to improve process capability is a plus
- Experience in statistical analysis using JMP or Minitab
- Proven track record of leading and managing cross functional teams
- Knowledge of data management tools and statistical process controls
- We are able to offer the opportunity to be part of 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.