Senior Engineer, Process Engineering - Early Stage Development - United States
Want to know company name or location? Company managed [?]
- 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.
- The Senior Process Engineer 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.
- The Senior Process Engineer will work with the Early Stage Product Sciences team to design, establish and scale-out cell therapy processes to support early phase clinical trials, manage equipment qualification and support process verification, as well as draft documentation for regulatory filings to advance company’s product portfolio.
- The Senior Process Engineer will also participate in laboratory activities to support process development and process characterization of our company’s autologous T cell products.
- Advance early-stage pipeline products into clinical process format, and subsequently provide technical oversight and support of GMP clinical manufacturing operations
- Design and execute process development studies to develop a thorough understanding of operating and performance parameters.
- Write and review technical documentation (batch records, SOPs, protocols & reports for FATs, SATs, IQ/OQ/PQ testing, and validation testing).
- Ensure successful manufacturing production runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues
- Perform hands-on activities that support process development and process characterization, ranging from drafting procedures to execution of laboratory studies
- A degree in Biochemistry, Chemical Engineering, Biotechnology or equivalent
- 5+ years of pharmaceutical manufacturing & process development experience
- Cell culture or aseptic processing experience is required
- Fluency with cGMP manufacturing, regulatory regulations and requirements for pharmaceuticals and devices
- Working knowledge of scientific and engineering principles
- Previous experience with cell therapy products is a plus
- Proficient in JMP and other such statistical software; Well-developed computer skills
- 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
- 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.