Alison Gillespie Email & Phone Number

Seattle, Washington, United States

Seattle, Washington, United States

Provided technical, analytical, formulation, quality control, CMC regulatory and strategic support for early to late-stage biopharmaceutical products. Performed risk assessments, conducted product comparability assessments, and authored reports, protocols and regulatory documents. Oversaw contract laboratory activities such as method development, GMP testing, method qualification and method transfers. Simultaneously provided consulting support for multiple client programs with experience supporting mAbs, ADCs, enzymes, gene therapies and novel modalities.

Seattle, Washington, United States

Seattle, Washington, United States

Built the QC organization from 2 to 14 staff over a 2-year period to support DS/DP release and stability testing, and facility EM monitoring for two GMP biopharmaceutical manufacturing facilities. Oversaw the QC facility laboratory design and build-out, including meetings with architects, contractors and internal finance teams to ensure timelines and budget goals were met.Authored internal platform guidelines, SOPs, analytical methods, strategy documents and assisted the business development team during the preparation of client SoWs and cost proposals. QC team lead for multiple client-facing programs that included authoring specification and stability protocols. Conducted HPLC, CE-SDS and compendial method analysis for the release and stability of GMP products. Provided subject matter expertise supporting GMP manufacturing deviation investigations and CAPA closures. Reviewed and approved all QC release and stability raw data packets.

Greater Seattle Area

Greater Seattle Area

Process Development Team LeaderSimultaneously led the process development and analytical teams for two FIH programs (Fc-fusion protein and mAb). Presented upstream, downstream, formulation and analytical scientific data to clients. Ensured process team stayed on timeline and met deliverables. Became skilled at managing client expectations and conflict resolution. Oversaw the analytical method development, qualification and transfer to QC, authored reference standard qualification protocols and reports. Scientist (Laboratory Benchwork)Developed and implemented a high-throughput biophysical characterization screening assay for early-stage pre-clinical development candidates. Executed experiments and identified a novel formulation for a biosimilar product. Oversaw the development of DS / DP release and stability GMP methods. Established a high throughput formulation platform to reduce product mass requirements to leverage HTP analytical techniques.

Greater Seattle Area

Analytical Science Team Leader Led the analytical development teams for two Phase 3 mAb programs. Developed the analytical comparability strategy for a 2nd generation commercial process that entailed significant process changes (new cell line, upstream, downstream, and harvest processes). Managed a cross-function team of SMEs to address immunogenicity and safety concerns associated with a new post translational modifications identified in the 2nd generation process material. Assessed the biological impact of CQAs to identify product comparability targets. Scientist (Laboratory Benchwork)Proficient mass spectrometrist with experience characterizing the hinge disulfide isoforms of IgG2 lambda and kappa light chains. Developed a wide range of release and characterization methods (MS-TOF, oligosaccharide analysis, intact mass, native/reduced peptide mapping, SEC and CEX). Authored assay qualification protocols and reports and executed method transfers to QC. Designed and executed comparability studies supporting late-stage process changes and the clinical development of a biosimilar product.

Greater Seattle Area

Greater Seattle Area

Greater Seattle Area

Ridgefield, Ct

Formulation development and analytical method development for large molecules. Small molecule formulation development and testing.