Alison Gillespie Email and Phone Number
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A biotechnology professional with 30 years of experience leading interdisciplinary process development, analytical and formulation teams to support pre-clinical, clinical, and post-commercial biopharmaceuticals and biosimilars. Experienced in managing CMC process development activities from cell line development through cGMP manufacturing.A self-motivated analytical consultant who is proficient in developing CMC regulatory strategies and authoring CTAs for FIH, late-clinical, BLA and 2nd generation processes. Skilled in identifying, characterizing, and developing approaches to control and manage critical quality attributes. Proficient at developing phase appropriate comparability strategies. Experienced building QC organizations, overseeing method transfer and qualifications, prioritizing DS/DP release and stability testing and managing equipment IOPQ.
Larimar Therapeutics Inc.
View- Website:
- larimartx.com
- Employees:
- 25
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Senior Director, Cmc Technical OperationsLarimar Therapeutics Inc. Nov 2024 - PresentSeattle, Washington, United States
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Cmc Consultant, Managing Director, Bioprocess Technology GroupBdo Usa Jan 2022 - Oct 2024Seattle, Washington, United StatesProvided 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. -
Cmc Consultant, Director, Bioprocess Technology GroupBdo Usa, Llp Jan 2022 - Aug 2024Seattle, Washington, United States
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Principal Scientist - Head Of Quality ControlJust - Evotec Biologics Apr 2020 - Jan 2022Seattle, Washington, United StatesBuilt 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. -
Senior Scientist - Qc Analytical Group LeaderJust - Evotec Biologics Aug 2019 - Apr 2020Greater Seattle Area
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Senior Scientist - Analytical SciencesJust Biotherapeutics Jun 2015 - Aug 2019Greater Seattle AreaProcess 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.
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ScientistAmgen 2010 - 2015Greater Seattle AreaAnalytical 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. -
Senior Associate ScientistAmgen 2005 - 2010Greater Seattle Area
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Associate ScientistAmgen 2002 - 2005Greater Seattle Area
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Research AssociateImmunex 2000 - 2002Greater Seattle Area -
Scientist I And Scientist IiBoehringer Ingelheim 1995 - 2000Ridgefield, CtFormulation development and analytical method development for large molecules. Small molecule formulation development and testing.
Alison Gillespie Skills
Alison Gillespie Education Details
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Molecular And Cellular Biology
Frequently Asked Questions about Alison Gillespie
What company does Alison Gillespie work for?
Alison Gillespie works for Larimar Therapeutics Inc.
What is Alison Gillespie's role at the current company?
Alison Gillespie's current role is Senior Director, CMC Technical Operations.
What is Alison Gillespie's email address?
Alison Gillespie's email address is ag****@****bdo.com
What is Alison Gillespie's direct phone number?
Alison Gillespie's direct phone number is +120697*****
What schools did Alison Gillespie attend?
Alison Gillespie attended University Of Connecticut.
What skills is Alison Gillespie known for?
Alison Gillespie has skills like Protein Chemistry, Biotechnology, Assay Development, Monoclonal Antibodies, Biopharmaceuticals, Life Sciences, Validation, Antibodies, Cell Culture, Drug Discovery, Cross Functional Team Leadership, Lc Ms.
Who are Alison Gillespie's colleagues?
Alison Gillespie's colleagues are Sue Kolb-Pickwell, Sarah Rose Moore, Keith L., Deb Winkler, Leigh Smith Ccdm (Old Account Hacked), Hannah Lynes, Nicholas Cooke, Mph.
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Alison Gillespie
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