This innovative Global Oncology Biotech clinical stage company with the scientific vision of revolutionizing the cancer treatment in various indications is moving ahead with strong clinical advancements. Company specializing in the cell therapy area. Both Phase II and IIl clinical development programs successfully underway. The company has built up robust operational and supply chain capabilities to successfully delivery cell therapy treatments to a large patient pool across global countries, and in US market planned for near future.
The process and analytical development team plays a key role in delivering critical scientific approach to understand and improve cell product attributes that would improve patient outcomes. In collaboration with our external partners, company research, Quality Control (QC) and Process Sciences (PSAT) teams, the VP will be in charged 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.
- BS, MS, PhD in immunology, oncology, bioengineering, cellular biology or related field
- 8 – 10 years pharma/biotech experience and at least 2 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.
- Extensive knowledge on analytical method development, optimization and method qualification strategies, in particular:
- 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)
up to $275K+ plus Annual Bonus + Equity Options package
PA/NJ/NY Area (REMOTE LOCATION in Tri-state area acceptable)
No, not at this time.
EP - 454