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CMC Process Development, Operations, and Program LeadConnect with me using: ►►► david_boisvert@comcast.net ◄◄◄LION – LinkedIn Open NetworkerRecruiters, HR Managers, and Hiring Managers connect with me to get access to my network deep in industry leadership.Process development and manufacturing director who integrates the business with scientific strategy resulting in high-quality products delivered on-time. More than 16 years of experience leading process and analytical development from research into commercial manufacturing. Proven track record of managing internal teams and external CMOs for fast-tracked programs, while using risk assessment, design space, and a team-based approach to optimize manufacturing processes and formulations.Background in research and development, managing development and manufacturing teams (internal and external), developing analytical assays for in-process control and product release/stability, scale-up and technical transfer of manufacturing processes, animal safety and efficacy studies. Expertise the protein engineering and manufacturing processes for E.coli, CHO and other mammalian cell lines. Experience with start-up ventures and bio-pharmaceutical companies.Specialties: Leadership, Project Management, Manufacturing, Therapeutics, Supply Chain, Regulatory, Outsourcing, CMC, Risk Mitigation, Troubleshooting, Scale-up, Fermentation, Purification, Cell Banks, Technical Operations, Cell Culture, Expression, PCR, Molecular Cloning, Assays, HPLC, Biochemistry, Molecular Biology, Biopharmaceuticals, Technology Transfer, ELISA, Biotechnology, R&D, FDA, Life sciences, GLP, GMP, Microbiology, CRO, Genetics, Product Development, Engineering, Biochemistry, Chromatography, Formulation, Manufacturing Support, Drug Discovery, DOE, Validation
Self-Employed
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Cmc And Biotechnology ConsultantSan Francisco, Ca, Us
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Cmc ConsultantSelf-Employed Jul 2020 - PresentProvide executive level CMC, technical operations, and manufacturing support for mammalian, microbial, or viral platforms. Assists with cell line development, CMC drug substance and drug product process development, analytical development, quality control support, stability program management, commercial manufacturing improvements, supply chain management, technical transfer, facility build-out considerations, author CMC sections of IND/IMPD/BLA, respond to regulatory agency inquires, product commercialization planning, process qualification, quality assurance support, investigations/root cause analysis, risk assessments, CDMO management, and CMC regulatory support for the EU, Canada, Australia, and US.
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Vice President | Process Development | Manufacturing | Supply ChainArch Oncology Apr 2017 - Oct 2022CMC head of outsourced antibody projects responsible for process development, manufacturing, fill/finish operations, labeling and packaging, supply chain management, program life cycle management, and ensure adherence to GMP quality and regulatory guidances.
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Associate Director | Commercial Manufacturing | Analytical TestingGrifols Jun 2016 - Mar 2017Sant Cugat Del Vallès, Barcelona, EsPurification and fill/finish operations lead for eleven different commercial proteins antigens, manufacturing up to three batches per week. Promoted efficient communication across departments and continuous improvement culture to maintain greater than 98% on-time delivery to customers. -
Consultant And Associate Director | Manufacturing Sciences And Technology | Analytical DevelopmentPortola Pharmaceuticals Mar 2014 - Jun 2016South San Francisco, Ca, UsLed upstream and downstream process characterization, scale-up, tech transfer, and initial commercial manufacturing of a Phase 3 biologic for commercial launch. Author of the CMC drug substance sections of the BLA. -
Director | Cell Line Development | BioproductionAragen Bioscience, Inc. Sep 2013 - Nov 2013Brought on board to oversee a group of eleven direct reports during the buyout-phase of the company to improve productivity and ready the group for pre-clinical manufacturing should the new owners choose to offer GMP services.
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Senior Scientist | Process Development | Business DevelopmentAllergan Oct 2009 - Sep 2013Dublin, Coolock, IeLed a team of four direct reports and helped manage the upstream pilot plant to develop three clinical-phase projects while promoting a safety-conscious environment for manufacturing select agents. Additionally, was the technical lead for in-licensed products provided market forecasts, supply chain estimates, and performed phase 3 re-development that was completed within 6 months. -
Senior Staff Scientist | Technical Operations | R&D | Business DevelopmentAerovance, Inc. Aug 2004 - May 2009An Aerovance founder who helped develop the initial business plan, secure $32M in Series A financing, set up new labs, and led the technical aspects of the CMC programs for four clinical phase and two discovery phase projects.
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Senior Scientist | Protein Engineering | ManagerBayer Jan 2001 - Aug 2004Leverkusen, North Rhine-Westphalia, DeLed a protein engineering group that discovered four lead candidates and resulted in three issued patents. -
Post Doctoral Fellow | Molecular Biology | Protein Purification | CrystallographyUc Berkeley Jul 1997 - Jan 2001Berkeley, Ca, UsWorked for Professor Sung-Hou Kim to subclone, purify,and crystallize hyperthermophilic proteins in support of the first structural genomics initiative, which resulted in securing a $5 million annual grant.
David Boisvert Skills
David Boisvert Education Details
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Yale UniversityGenetics And Biophysics -
University Of ConnecticutMolecular And Cell Biology
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University Of PhoenixGlobal Management
Frequently Asked Questions about David Boisvert
What company does David Boisvert work for?
David Boisvert works for Self-Employed
What is David Boisvert's role at the current company?
David Boisvert's current role is CMC and Biotechnology Consultant.
What is David Boisvert's email address?
David Boisvert's email address is da****@****ast.net
What is David Boisvert's direct phone number?
David Boisvert's direct phone number is +151091*****
What schools did David Boisvert attend?
David Boisvert attended Yale University, University Of Connecticut, University Of Phoenix.
What are some of David Boisvert's interests?
David Boisvert has interest in Boating, Kids, Cooking, Collecting Antiques, Investing, Outdoors, Electronics, Home Improvement, Reading, Gourmet Cooking.
What skills is David Boisvert known for?
David Boisvert has skills like Biotechnology, Biopharmaceuticals, Purification, Drug Development, Protein Chemistry, Cell, Technology Transfer, Molecular Biology, Life Sciences, Glp, Gmp, Cell Culture.
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