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Senior Engineer, Process Engineering - Process Sciences Santa Monica United States,
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Posted on : 12 May 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 Senior / Principal Process Engineer, you will provide process development and engineering support for technology transfer, process validation and GMP manufacturing for our company s engineered autologous T cell therapy products.
- Primary responsibility will be to engage in automation and technology development activities within the company , and associated business partners.
- Additionally, you will draft and review protocols, production procedures, 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, and support process validation, as well as draft documentation for regulatory filings to advance company s product portfolio.
Responsibilities include, but are not limited to:
- Perform development and implementation of new process technology
- Perform process design and process simulation studies to support process automation projects
- Perform laboratory process development studies and author technical reports
- Write and review technical documentation (development reports, batch records, SOPs, protocols & reports for FATs, SATs, IQ/OQ/PQ testing, and validation testing)
- Perform process monitoring, process capability, statistical analysis and quality engineering activities
- Support technology transfer and oversee GMP manufacturing operations
- 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 hands-on activities that support process development and process characterization, ranging from drafting procedures to execution of laboratory studies
- 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
- BS or MS degree in Biochemical Engineering, Chemical Engineering, Biotechnology or equivalent with 5+ years of experience. Engineering degree preferred
- Working knowledge of cGMP manufacturing and regulatory regulations and requirements for biologics, pharmaceuticals and medical devices
- Cell culture experience
- Experience performing process design and process automation is a plus
- Read and interpret drawings such as blueprints, PFDs, P&IDs, AutoCAD, PLC
- Experience in statistical analysis using JMP or Minitab
- Experience performing discrete event simulation is a plus
- Working knowledge of scientific and engineering principles
- Certified Quality Engineer, Six Sigma Green Belt, Six Sigma Black Belt or similar is a plus
- Equipment qualification experience in a cGMP environment (IQ, OQ, PQ) is preferred; process validation experience is a plus
- Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products, and process development
- Must be able to function and contribute as part of a team, have excellent communication skills and contribute to team based decisions
- 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 and fluent with Microsoft office applications
- 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
- Our company is an equal opportunity employer.
- 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.
Santa Monica CA
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