Mary Beth Pelletier, Phd, Mba Email and Phone Number
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I am an experienced and passionate technical leader with over 15 years of experience in biotechnology operations, with expertise in Quality leadership, analytical method development and validation, Quality Control (QC), and Chemistry and Manufacturing Controls (CMC) leadership for biologics and gene therapy. I am passionate about building teams and developing leaders to empower each of us to be and give our best. I believe in continuous learning, and in addition to a PhD in Chemistry I have completed a Regulatory Affairs Certification (RAC) and an MBA with a focus in Business Leadership.I am currently the VP of Quality Control (QC) for Apogee Therapeutics, a clinical-stage biotechnology company seeking to develop differentiated biologics for inflammatory and immunology indications with high unmet need. I previously led QC at Intellia Therapeutics and was the Head of Quality for Biogen's Gene Therapy Manufacturing greenfield startup. Prior to that role, I led Biogen’s Global QC-Analytical Technology organization of approximately 40 scientists in United States and Europe who deliver analytical method validation, transfer, and modernization for release, stability, and in-country testing of Biogen’s biologics and gene therapy pipeline from phase 1 through product lifecycle, including a $4B commercial portfolio. We performed release testing of clinical products under GMP and provided subject matter expertise to resolve testing-related investigations at internal and contract testing laboratories. We developed and implemented compliant global testing site strategy to enable drug launch and continual supply to patients in approximately 100 markets.I have also led all CMC activities for two clinical-stage biologics programs, driving all activities including development, manufacturing, supply chain, and regulatory aspects to ensure continuous compliant supply to patients in clinical trials.I believe deeply in the role of global harmonization to facilitate CMC development and lifecycle management, ultimately ensuring patients around the world can access the highest quality therapeutics. I am currently the BIO Topic Lead on the ICH Q2/Q14 Expert Working Group; we are authoring globally harmonized guidance on analytical method development, validation, and lifecycle management with the goal to deliver Step 4 documents for implementation at the end of 2023.
Apogee Therapeutics
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Vice President, Quality ControlApogee Therapeutics Jul 2024 - PresentFully Remote, Us, Us
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Ich Q2(R2)/Q14 Expert Working Group: Analytical Procedures (Topic Leader - Bio)Biotechnology Innovation Organization Nov 2018 - PresentWashington, Dc, Us -
Head Of Quality ControlIntellia Therapeutics, Inc. Oct 2023 - Jun 2024Cambridge, Massachusetts, Us▪ Lead QC organization to deliver timely and compliant outsourced testing and analytical method validation/transfer support at Contract Manufacturing Organizations (CMOs) and Contracting Testing Laboratories (CTLs) for in vivo and ex vivo gene editing programs, including lipid, mRNA, gRNA, viral vector, and lipid nanoparticle (LNP) modalities▪ Implement and evolve compliant strategies for QC Quality Management Systems (QMS) in support of an anticipated clinical to commercial transition, such as stability, reference standard, analytical procedure lifecycle ▪ Represent QC and Intellia in Health Authority and partner interactions including submission documentation strategy and preparation for global markets, as well as audits/inspections -
Head Of Qa&Qc, Gene Therapy ManufacturingBiogen Sep 2021 - Sep 2023Cambridge, Ma, Us▪ Designed organization and then recruited, coached, and led Quality Control and Quality Assurance functions, driving compliant design, build, and GMP start-up of Biogen’s $200M greenfield Gene Therapy Manufacturing Facility▪ Identified and led QMS update to include rapidly evolving global gene therapy regulations▪ Drove risk assessments ensuring optimal strategies for facility design, start-up, and operations▪ Established platform control strategy and QC testing capabilities for plasmid, drug substance, and drug product▪ Represented and advocated for Quality on Site Leadership Team and Capital Project Steering Committee▪ Successfully drove culture development and employee experience -
Cmc Asset LeadBiogen Aug 2018 - Oct 2021Cambridge, Ma, Us▪ Led matrix team responsible for all CMC activities for two clinical biologic programs, including development, manufacturing, supply chain, and regulatory submission/responses, ensuring continuous compliant supply to patients in clinical trials, in partnership with Non-clinical, Clinical, and Commercial functions▪ Developed and iterated CMC product strategy, including short-term and long-term development timelines and supply projections, delivering timely supply of clinical sites▪ Saved $1.2M and diverted 17000 vials of drug from waste to patient supply by identifying opportunity after change in clinical trial plan
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Head Of Global Large Molecule & Gene Therapy Qc Analytical Technology (Associate Director/Director)Biogen Nov 2015 - Aug 2021Cambridge, Ma, Us▪ Built and led QC-AT organization of approximately forty scientists in United States and Europe who delivered analytical method validation, transfer, and modernization for release, stability, and in-country testing of Biogen’s biologics and gene therapy pipeline from phase 1 through product lifecycle, including a $4B commercial portfolio ▪ Performed release testing of clinical pipeline products under Good Manufacturing Practice (GMP) and provided subject matter expertise to resolve testing-related investigations at internal and contract testing laboratories▪ Designed and implemented global testing site strategy, enabling continual supply to patients in ~ 100 markets▪ Interfaced with cross functional teams to devise globally acceptable regulatory and control strategies which minimize impact on product supply chain, resulting in reduced costs, lead times, and compliance risks in support of clinical supply and commercial launch of products▪ Led Quality line engagement for site selection, design, and start up for Gene Therapy Manufacturing facility▪ Authored, reviewed, and approved technical reports, presentations, regulatory submissions, and regulatory responses
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Scientist I/Scientist Ii/Senior Scientist, Large Molecule Qc Analytical TechnologyBiogen May 2010 - Nov 2015Cambridge, Ma, Us▪ Implemented analytical methods for QC testing of late-stage clinical and commercial biologics programs through method development, qualification, optimization, validation, and transfer ▪ Represented QC on cross functional product team, interfacing across CMC functions achieving approval for, launching, and supporting commercial lifecycle management for multiple biologics across global markets▪ Designed and analyzed analytical testing of returned patient samples in support of patient / health authority product complaints for licensed products
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Research Scientist/Senior Research ScientistTalecris Biotherapeutics Sep 2006 - May 2010Research Triangle Park, Nc, Us▪ Developed and qualified analytical methods for characterization, release, stability, and process analytical technology (PAT) testing of identity and purity analysis of recombinant and plasma-derived proteins▪ Performed analytical investigations for resolution of deviations in manufacturing of clinical and commercial biological products, directly enabling product release decisions of up to $3M per batch▪ Characterized post-translational modifications of proteins informing product risk-benefit analyses ▪ Led Developmental Stability function, including four scientists, providing stability study design, administration, analysis, reporting, and expiry assignment per ICH Q1 guideline across multiple biologics in support of clinical product development▪ Built and implemented GMP-compliant phase-appropriate quality systems and business processes ensuring data were suitable for regulatory submissions -
ScientistAmgen May 2004 - Sep 2006Thousand Oaks, Ca, Us▪ Designed, evaluated, and optimized formulations for high concentration biologics maximizing shelf-life▪ Developed stability-indicating methods to analyze protein purity and detect degradation▪ Analyzed in-use stability, delivery device compatibility with drug product, and leachable / extractable profile ensuring patient safety and enabling product use in clinical trials -
Post-DocThe Scripps Research Institute Sep 2003 - Apr 2004La Jolla, California, Us
Mary Beth Pelletier, Phd, Mba Skills
Mary Beth Pelletier, Phd, Mba Education Details
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North Carolina State University - College Of ManagementMaster Of Business Administration - Stem Mba -
Scripps ResearchChemistry
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Northwestern UniversityChemistry
Frequently Asked Questions about Mary Beth Pelletier, Phd, Mba
What company does Mary Beth Pelletier, Phd, Mba work for?
Mary Beth Pelletier, Phd, Mba works for Apogee Therapeutics
What is Mary Beth Pelletier, Phd, Mba's role at the current company?
Mary Beth Pelletier, Phd, Mba's current role is Passionate People Leader | Biologics & Gene Therapy CMC | Quality | Analytical Method Validation.
What is Mary Beth Pelletier, Phd, Mba's email address?
Mary Beth Pelletier, Phd, Mba's email address is ma****@****hoo.com
What schools did Mary Beth Pelletier, Phd, Mba attend?
Mary Beth Pelletier, Phd, Mba attended North Carolina State University - College Of Management, Scripps Research, Northwestern University.
What skills is Mary Beth Pelletier, Phd, Mba known for?
Mary Beth Pelletier, Phd, Mba has skills like Biochemistry, Protein Chemistry, Biotechnology, Purification, Biopharmaceuticals, Drug Discovery, Chromatography, Technology Transfer, Hplc, Antibodies, Protein Purification, Lifesciences.
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