Vice President, Process and Analytical Development
Proclinical is currently recruiting for a VP of Process and Analytical Development for a biotechnology company located in Princeton, NJ. Successful candidate will be in charge of creating and delivering on early stage candidate processes and analytical strategies that will lead to successful commercialization with competitive COGs and reliable supply.
- Lead process and analytical development effort in translating cell therapy candidates from our collaborators for later stage clinical trial
- Set priorities for and assure productivity of teams to meet the dynamic needs of the cell therapy portfolio
- Establish and optimize robust, compliant, scalable and economically viable processes that will meet cGMP requirements
- Develop product characterization strategies and process understanding for our T cell portfolio; as well as correlation with clinical outcomes
- Develop, optimize and qualify release analytical methods required to meet commercial specifications of T cell products
- Benchmark industry best practices and develop, evaluate and recommend new process technologies and methods
- Plan and execute development strategies in coordination with CMC project management for Ph 1/early stage and translational products
- Support PSAT and QC by transferring analytical methods and process to GMP manufacturing as well as carry out process improvements and product characterization
- Transfer knowledge about the product and processes to the operational functions
- Support comparability approaches for analytical methods or manufacturing process changes
- Support the writing of IND packages and initial manufacturing for early phase clinical trials
Skills and Requirements
- PHD in immunology, bioengineering, cellular biology or related field
- 10 years industrial experience and at least 3 years' experience supporting GMP manufacturing or operating in a GLP environment
- Experience with primary cells, T cells, NK cells as well as establishing T cell isolation, engineering and propagation processes
- Knowledge of method qualification strategies for cell-based assays, flow cytometry
- Establishing relevant assay controls, references or system suitability checks
- Experience in GLP/GDP requirements for development processes, including authoring IND documents and other developmental reports
- Familiar with GMP manufacturing issues include material and equipment selection, process scale-up and comparability
- Familiar with Quality by Design principles, focused on cell therapy applications
- Experience in statistical methods including design of experiments (DOEs) or analyses (e.g JMP)
- Able to work in a highly cross-functional, matrix and ambiguous environment
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matt Tong at (+1) 646-878-6308 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.