Mary Beth Pelletier, Phd, Mba Email & Phone Number

Fully Remote, Us, Us

Washington, Dc, Us

Cambridge, 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

Cambridge, 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

Cambridge, 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

Cambridge, 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

Cambridge, 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

Research 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

Thousand 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

La Jolla, California, Us

Master Of Business Administration - Stem Mba

Phd, Chemistry

Ba, Chemistry