Process Engineer - United States
Want to know company name or location? Company managed [?]
Posted on : 06 June 2017
- 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 Process Engineer, you will provide process development and engineering support for process design and development, process characterization, and leading process improvements in GMP manufacturing.
- Primary responsibility will be to lead and execute lab studies to develop and characterize the manufacturing process.
- Experiments will be performed to identify and define Critical Process Parameters and process ranges.
- Additionally, you will draft and review study plans and reports, analyze and trend process data, perform Design of Experiment (DoE) , and provide technical support for engineering and process changes.
- You will work with the Process Science & Engineering team to design and scale-out cell therapy processes, and support process characterization, as well as draft documentation for regulatory filings to advance company's product portfolio.
Responsibilities include, but are not limited to:
- Lead and execute laboratory studies to support process design and development, characterization and process improvements
- Perform hands on work in a cell culture lab
- Write and review technical documentation
- Participate and report to a cross-functional development team to advance production activities
- Develop manufacturing processes for cell therapy products and develop process improvements and efficiencies
- Perform process analysis and trend process performance
- Design and execute process development studies to develop a thorough understanding of operating and performance parameters
- Act as technical expert to train and supervise process technicians
- Perform risk assessments
- Provide technical support for selection of raw materials and process materials
- Other duties as assigned
- Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology or related discipline with pharmaceutical/biotech manufacturing & process development experience required
- Fluency with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
- Be familiar with basic cell culture lab techniques such as cell passaging, cryopreservation, formulation of media, aseptic technique using a BSC, cell counting, calculation of reagent quantities
- Working knowledge of scientific and engineering principles
- Experience in statistical analysis using JMP or Minitab
- Practical experience in GMP operations
- Document work accurately using GDP
- 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
- Pharmaceutical products GMP manufacturing experience is a must
- Cell culture and aseptic processing experience is a must
- Process modelling and simulation experience is a plus
- Previous experience with cell therapy products is a plus
- Process validation experience in a cGMP environment is a plus
- Process automation experience is a plus
- Six Sigma Green Belt or Black Belt certification is a plus
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities