Our client is seeking an Analytical Method Development Expert for a 6-12 month contract. This individual should be an accomplished analytical leader who will provide strategic technical leadership for method development lifecycle to support their cell therapy portfolio. In this highly visible role, the individual will: engage both internal and external partners to define analytical requirements; develop and implement analytical lifecycle strategies for development, validation, and transfer initiatives; support regulatory submissions as the analytical subject matter expert; lead the transfer and implementation into QC facilities for clinical and commercial testing. He / She will serve as a key leader in advancing client’s novel allogeneic viral specific T cell therapeutics and in establishing internal lab capabilities.
- Lead the establishment of the analytical lifecycle management strategy to develop phase appropriate test methods.
- Lead the development, optimization, qualification, and validation of test methods intended for routine and non-routine testing of in-process and drug product release samples. Establish the product characterization, lot release and stability testing panels.
- Lead the establishment of product specifications through application of appropriate statistical tools and scientific rationale.
- Develop analytical comparability strategies through selection of appropriate characterization test methods and justification of comparability criteria.
- Evaluate new assay technologies and innovate novel methodologies to improve existing analytical methods.
- Lead engagement with internal and external analytical partners, including external contract development/testing laboratories.
- Establish assay trending and monitoring program in concert with internal partners.
- Provide oversight of internal and external method development projects.
- Participate in cross functional program teams as the Analytical Development (AD) representative, and influence cross-functional partners to support PD objectives.
- Support CMC regulatory submissions (IND, BLA, etc) via authorship, review, approval of relevant CTD sections.
- Identify and implement operational improvements and novel technological approaches to improve yield and key quality attributes.
- Provide laboratory support for manufacturing deviation investigations and evaluation of raw material and consumables changes.
- Author / review / approve technical documents (SOPs, protocols, reports, risk assessments, specifications, etc).
- Education: Advanced degree in immunology, cellular biology, biochemistry or related field (PhD preferred,) and 8-10 years of experience.
- In-depth understanding of immunology and cellular biology with application to development of analytical methods that reflect the drug products mechanism of action (strongly preferred).
- Extensive experience in all phases of the method development lifecycle (development, optimization, qualification, validation, method transfer).
- Demonstrated in-depth knowledge and hands-on experience in the development, optimization and troubleshooting of either bioassays or flow cytometry is required (experience with both is strongly preferred).
- Experience and fluency with the following: flow cytometry / FACS, ELISpot, ELISA, cell culture / cell-based bioassays, microscopy. Prior experience developing potency and/or immunophenotyping test methods for cellular therapies is strong preferred.
- Experience leading the establishment and justification of specifications, including developing specification setting strategy (e.g. batch testing strategy, selection of statistical analysis approaches, etc.)
- Experience in transferring methods to internal and external QC organizations is required.
Remote: Analytical Method Development Expert – Cell Therapy (231338)