Lead QC & Analytical Development efforts in support of the Insmed Gene Therapy platform. •Member of the Gene Therapy Executive Committee •Manage and lead daily activities of the analytical laboratories and mentor and develop direct reports. •Interpret complex data, solve scientifically challenging problems & provide direction/leadership. •Build and lead the analytical development and quality control laboratories and contribute to the overall CMC strategy of drug development from discovery through clinical development and commercial. •Evaluate, design, and perform method development and validation employing phase- appropriate approaches at different stages of development (pre-clinical through Phase 3) for assay, purity, identification of impurity and degradation products, reference standard qualification and physical (solid-state) characterization of drug product and drug substance.Analytical Development: •Manage all aspects of analytical procedure development both internally and at contract labs. •Conduct pre-formulation and stability studies on lead compounds.Quality Control: •Manage an internal QC laboratory to support product release and stability testing. •Setup compliant systems to make facility inspection ready as the lab of record. •Oversee management of Quality Control operations at CMO and contract testing laboratories, including managing contract relationships in parallel with implementing in-house testing. •Design and implement a stability program, reference standard program, and support in-process, and release testing throughout the product lifecycle for all Insmed gene therapy programs.•Closely coordinate with QA and Regulatory, as well as other CMC functions, Clinical andToxicology regarding safety-related questions on APIs, components of APIs and formulations and materials used in processing

Lead analytical development team for the development, optimization and qualification of analytical methods for the characterization, in-process, release and stability testing of the company’s cell therapy, gene editing and rAAV gene therapy products. Lead the Quality Control group for release and stability testing of rAAV based in-vivo gene therapy productsResponsible for overseeing core analytical activities at the company’s designated Contract Manufacturing Organization’s (CMOs) and ensuring successful technology transfer to either CMOs, Contract Testing Organizations (CTOs), or to the Company’s in-house Quality Control (QC) department.•Ensure methods are developed appropriately to address quality target product profiles in accordance with applicable ICH guidelines (Q1 & 2, Q5 & 6 and in anticipation of Q14) as well as FDA/EMA/applicable global health authority requirements and expectations.•Proactively engage in collaboration with internal and external stakeholders, identifying trends and expectations in the cell and gene therapy modalities and incorporate them into the analytical control strategies. Lead data-driven, phase & risk appropriate approach to method development and specification setting.•Author and/or review relevant sections of CMC documentation in support of regulatory submissions. Actively support inspection readiness activities and associated health authority Inspections•Manage an internal analytical core to support process development and formulation development. •Make sound decisions regarding complex technical issues and communicate decisions effectively with internal stakeholders, elevating complex issues as appropriate•Attract and recruit top talent, motivate and empower, delegate effectively, celebrate diversity, and manage performance

Responsible for leading CMC analytical activities for the production of Ultragenyx toxicology, clinical trial materials and commercial products. Work with contract organizations including CMOs and Contract Laboratories (CLs) to ensure appropriate ICH and regulatory quality standards are met during product development and production. Collaborate closely with cross-functional departments such as Technical Operation, Quality Assurance, Project Management, Supply Chain and Regulatory to achieve corporate goals and objectives.Led the analytical activities for IMP drug substance (DS) and drug product (DP)/placebo from GLP Tox to GMP manufacturing (Phase I-III) for all quality control and analytical development activities.Oversight and management of CRO/CMO QC operations. Manage the development and validation of analytical test methods used for release and stability monitoring of clinical and commercial products in accordance with ICH/FDA/EMA/USP/Ph. Eur. Guidelines.Managed analytical method transfer process from development labs to QC testing sites.Developed a risk based Analytical and QC redundancy system to ensure that critical analytical assets are not on a critical path. Provided strategic guidance and support on molecular structural characterization of protein and mRNA products. Including Product Comparability studies to support Process development and changes. Provide technical review of analytical data integrity and laboratory documentation, method development reports and method validation protocols/reports.Authored, updated, and revised CMC regulatory filing sections to support regulatory filings. Addressed CMC comments regulatory responses.

I played a critical role in advancing the firm’s scientific agenda. I managed analytical technology operations and led teams ranging in size from three to 24 in supporting client manufacturing processes. I also provided scientific leadership to my team and collaborated with multiple groups to evaluate and implement solutions to development problems. Under my leadership, we delivered high quality, efficient and compliant operations. Key Accomplishments:- I met all client method development and transfer timelines to enable PPV runs to occur both on time and within budget. - Resolved potential 483 observations and served as subject matter expert (SME) on several regulatory inspections and acting as analytical lab SME for several client observations on method transfers and OOS investigations. - I led strategic efforts to position Ajinomoto Althea as the industry’s first fill site for ADCs, a new class of anti-cancer drug with a multi-billion dollar market potential, by providing scientific insight to team bringing a new facility on line for the fill, finish, release, and stability testing of class 4 and 5 compounds. - I designed the infrastructure for the new lab facility, helping secure a state manufacturing license, hiring an innovative and high-performing team, designing the laboratory space layout to enhance safety controls and planned and acquired over $2.5 million of laboratory capital. - I saved the company approximately $250,000 a year by recruiting and managing a LIMS Administrator and implementing a LIMS project.- I saved Althea approximately $250,000 a year and increased compliance, safety and waste disposal by reducing toxin contamination of paper by replacing paper with electronic systems.- I reduced the cost of releasing raw materials by ~ $187,000 a year by conducting a value-stream mapping of QC raw materials processes that decreased the number of steps in the process from 87 to 52

I led quality control (QC) operations, directing raw materials, lot release and stability testing for several high-profile clients. I managed a team of 18, implementing standard operating procedures (SOPs) and undertaking process improvement efforts to streamline department operations using lean manufacturing and six sigma concepts. I provided scientific leadership, as well, serving on the Leadership Board to monitor business governance. I also collaborated with the business development team to increase profitability, including providing scientific input on requests for information and proposals (RFI/RFPs).Key Accomplishments:- I increased laboratory throughput and improved inspection outcomes by modernizing the QC laboratories with equipment upgrades and the implementation of paperless processes. - I enhanced profitability by expanding the company’s QC service offerings, enabling the company to compete with larger fill/finish CDMOs. I helped create new market opportunities for clients looking for full analytical testing services all handled by one CMO to simplify supply chain and quality oversight. - I ensured timely and within budget method validations by participating as part of the Peregrine Pharmaceuticals CMC team as a consultant/individual contributor for lead Phase III/commercial drug product candidate. - I increased the QC team’s capabilities by expanding 'submission ready' stability reports for clients as well as increase storage solutions meeting all four world climactic zones for liquid dose formulations.

I developed and executed strategic plans to advance the company’s AD and QC operations, managing a team of 20. I led the release and stability testing of early phase clinical trial material manufactured in the Oceanside facility and outside analytical methods performed at CDMOs. I set analytical strategies for phase III candidates with respect to release, validation, characterization and Type C regulatory compliance. I reviewed biologics regulatory filings and analytical technical assessments, and served as a SME for quality audits. I established quality and operational standards by devising controls, environmental monitoring, inspection and testing methods and procedures. I oversaw training and compliance with GMP guidelines and monitored all GMP log release and stability activities for raw materials, drug substance, and drug products. I also directed administrative and contract service operations to ensure optimal and compliant outcomes and inspected contract-testing laboratories to evaluate operations.Key Accomplishments:- I developed and implemented a five-year business plan for the analytical department to support all development and quality needs of incoming projects. Achieved successful elucidation of structure by identifying all product variants and ensuring 100% sequence coverage of primary structure. - I built a team from seven to 20, training staff on AD and QC operations for the release and stability testing of early phase molecules. - I earned state licensure (FDB approval) by directing the team successfully through state board inspection. - I advanced product phase III clinical trial material supply by ensuring successful technology transfer to a Phase III CMO for all QC procedures and validations.- I ensured successful product quality lifecycle management by serving as the AD CMC team representative for phase III new biologic entity, Simtuzumab, and overseeing two early stage products

I managed development and quality control functions for products, from phase 1 through development to product commercialization. I directed a team of 18 employees in managing development and testing operations within the biologics development organization. I collaborated with manufacturing facilities for the development, manufacture, testing and packaging of clinical and commercial product. I also developed and provided input on impact assessments and tracked implementation to ensure a compliant, file-able product.Key Accomplishments: - I was promoted by senior management in recognition of expertise in biologics and successes in implementing continuous improvements, to head an initiative to enhance the biologics CMC organization. - I streamlined operations and improved product line success by creating and leading a centralized biologics CMC organization to handle all cross-functional and inter-departmental interactions with Clinical, Marketing, Non-clinical, Regulatory Affairs and Quality. - I built company success by assisting in securing the BOTOX™ second-generation process for post-market approval filing; serving as transition team member for several neurotoxin derivatives, mAbs; and a DARPin molecule facilitating early and late stage testing

I directed all process analytical support testing activities for Botox™ and other new protein molecular entities transitioning from discovery to development. I managed a team of 16 in handling all testing and development operations, and set and managed the budget forecasts for Biopharmaceutical and Biopharmaceutical Process Sciences. I provided direction and leadership in the development and implementation of quality systems in support of GMP regulations and ensured compliance with all federal, state and corporate policies. I also served as a SME to the Allergan Biopharmaceutical Reference Standard Team, Critical Materials and Reagents Team, and Global Biologics Business Harmonization team. Key Accomplishments:- I improved customer support by providing departmental management with guidance on implementing Quality by Design and continuous improvement methodologies such as Six Sigma and Lean principles. - I increased testing lab efficiencies by 20 to 75% by leading several Kaizen and 5S events.- I accelerated testing and development by leading an initiative to unify laboratory workflows and implement enterprise systems such as LabWare LIMS, Cerity SDMS and electronic laboratory notebook (ELN), and Empower2 CDS