Michael Furlong
Associate Director, Bioanalysis @Crinetics Pharmaceuticals
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WORK HISTORY
Associate Director, Bioanalysis @Crinetics Pharmaceuticals
NH, US
Oversee regulated and non-regulated bioanalysis activities in the US, Canada, and China.Lead author of bioanalytical content for a successful NDA submission; PALSONIFY was approved by the FDA in 2025.Lead author on responses to bioanalytical questions from the FDA and the EMA.
EDUCATION
Wayne State University
Master of Science (MS), Pharmaceutical Sciences
Purdue University
Doctor of Philosophy (Ph.D.), Medicinal Chemistry
University of Windsor
Bachelor of Science (BSc), Chemistry and Biochemistry
SKILLS
ABOUT MICHAEL FURLONG
Experienced bioanalytical scientist, proficient in all phases of the bioanalytical (BA) lab outsourcing life cycle, including BA lab identification, pre-qualification and onboarding, operational, technical, and financial oversight of lab activities, and authoring/reviewing of bioanalytical content in regulatory submissions.Bioanalytical technical expert• LC-MS/MS bioanalysis of small molecule drug candidates, biomarkers, and monoclonal antibodies.• Hands-on LC-MS/MS laboratory and Principal Investigator experience in GLP-regulated and non-regulated Pharma, Biotech, and Contract Research Lab (CRO) environments.• Knowledgeable of key bioanalytical guidances (e.g, ICH guideline M10 on bioanalytical method validation and study sample analysis).• Lead author on numerous bioanalytical scientific publications.• Basic knowledge of ligand binding assays and molecular biology assays (PCR, sequencing).Experienced in developing and leading partnerships with bioanalytical CROs• New partnership initiation in conjunction with finance, legal, and QA colleagues, including non-disclosure agreements, master service agreements, pricing negotiations, and QA audits.• Responsible for all aspects of BA lab contracting, including review and approval, change orders, and invoice review/approval. • Conduct regular TCs with BA lab program managers to discuss progress toward deliverables and troubleshoot technical/timeline challenges as needed.Bioanalytical lead on clinical and nonclinical study and program teams• Collaboration with Clinical Pharmacology, Toxicology, Toxicokinetics, Clinical Operations, Data Management, DMPK, Quality Assurance, and other functions/vendors, to ensure that BA labs provide high quality and timely pharmacokinetic/toxicokinetic sample concentration data and reports.• Partner with medical writing and regulatory colleagues/vendors to deliver high quality BA sections of INDs, NDAs, MAAs, toxicokinetic reports, clinical study reports, etc.• Contribute to PK/TK sample collection sections of clinical site manuals and nonclinical study protocols.• Facilitate BA lab review and finalization of data transfer agreements.Working knowledge of DMPK principles, including Phase 1/II metabolic pathways, drug-drug interactions, and noncompartmental pharmacokinetic analysis/WinNonlin experience.Lab-based bioanalytical positions include Pfizer, Vertex, Absorption Systems, Lexicon Genetics, and Genelabs Technologies.
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