Judy Cohen

As the Sr Vice President of Technical Operations, I am accountable for the overall CMC development, manufacturing and supply chain strategy for clinical and commercial supply drug product. Determine operations and manufacturing strategies to ensure attainment of financial and strategic goals, translating strategy into tactics, priorities and resource requirements. In addition, oversee the execution of manufacturing, materials, procurement, and logistics and manages the production from early-stage product development to commercial manufacturing upon FDA approval. Also responsible for outsourcing strategies and partnership management to achieve successful outcomes. Specific Duties: • Leads the External Manufacturing, Tech Ops, Supply Chain, and Quality teams • Logistics strategy and oversight of supply chain management activities to deliver products to clinical trials and/or market within defined regulatory, legal, quality and cost standards • End to end supply value chain for both the products interacting and interfacing with the global drug substance and drug product CMOs, CPOs, Serialization Track and Trace partner, and 3PL • Negotiating contract supply agreements, SOWs, and master service agreements with CMOs/CDMOs/Suppliers • Management of development project with third party manufacturers to achieve launch timelines • Achieve compliance and business results through partnership between quality assurance unit, operations and other site functions. Is able to contribute to the general management of the business and is the company representative in quality issues. • Ensure that the Braeburn activities are compliant with regulatory requirements and site quality systems. Oversees the effective generation and implementation of an efficient system of quality authored specific policies and SOP’s.

Head of Quality and senior management responsible for all Quality aspects ensuring compliance to current global regulatory standards as well as internal procedures. Oversight of 5 direct reports (16 QA personnel) representing Quality Assurance, Quality Control, Sterility Assurance and Regulatory Affairs Partnered with Operations and Technical Operations organizations to improve compliance profile of manufacturing. Championed process harmonization and standardization activities in areas of quality, compliance, tech transfer, metrics, etc. Responsible for all regulatory agency interactions including FDA, DEA, OSHA, and EPA. Planned and executed first FDA Pre-approval Inspection. Trained in Pharmaceutical Quality Systems (ICH Q10/ISO9001) Knowledgeable of FDA regulations [21 CFR Part 210/211 and 21 CFR Part 820], Drug and Medical Device Product Development processes, ICH guidelines, Design/Change Control and International Pharmaceutical Excipient Council guides. Experienced in writing and reviewing of Chemistry, Manufacturing and Controls (CMC) sections for regulatory filings

Senior management representative responsible for all Quality aspects (both QA and QC) ensuring compliance to current global regulatory standards as well as internal procedures. Providing Quality leadership to sterile manufacturing and microbiology topics for non-sterile and bio-burden reduced products across the company. Ensure that all processes contributing to the preparation of finished drug products to support GLP toxicology studies and cGMP clinical trial are conducted in accordance with company policies and regulatory requirements. Responsible for the quality assurance department and personnel with a focus on coordinating the development and management of all Quality Assurance related activities such as development and implementation of the Quality Measurement System (QMS). Overall responsibilities include: Responsible for maintaining overall qualified state of aseptic processing area including multiple clean room suites Quality release of all drug product for nonclinical and clinical studies Oversees the effective generation and implementation of an efficient system of quality authoring specific policies and SOP’s. Represent the company during external client and regulatory agency inspections Keep up to date with all related quality legislation and compliance issues

Ensure that all processes contributing to the preparation of finished drug products to support GLP toxicology studies and cGMP clinical trial are conducted in accordance with company policies and regulatory requirements. Responsible for the quality assurance department and personnel with a focus on coordinating the development and management of all Quality Assurance related activities such as development and implementation of the Quality Measurement System (QMS). Overall responsibilities include: -) Manage all quality activities for release of drug product to support nonclinical and clinical studies -) Oversee documentation efforts to ensure compliance with domestic and international regulations and standards. -) Represent the company during external client and regulatory agency inspections -) Manage and maintain databases for the quality system and prepare annual reviews and quality trending reports -) Keep up to date with all related quality legislation and compliance issues

Quality lead role for the department acting as resource for all internal and external audits Responsible for periodic review of departmental documentation Developed all standard operating procedures including those for lab investigations/deviations Ensured appropriate training curriculum and maintained training records as needed Managed qualification of all laboratory instrumentation to 21CFR Part 11 standard Addressed all non-conformances resulting from both internal and external audits Manage a cross-functional team in the characterization of products and processes in support of all Johnson & Johnson sectors; Consumer, Pharmaceutical and Medical Device & Diagnostics. Specific areas of expertise include knowledge of large-scale manufacturing processes and production facilities to aid in key manufacturing investigations, analytical methodologies for the isolation and chemical characterization of particulates, and thorough understanding of FDA regulations [both CDER and CDRH] including 21 CFR Part 210/211 and 21 CFR Part 820] to ensure cGMP compliance of our department. Knowledgeable of Drug and Medical Device Product Development processes including cGMP requirements, global ICH guidelines, Design/Change Control and International Pharmaceutical Excipient Council guides for use in toxicological studies, human clinical trials, and commercialization. Responsible for preparation of key reports, regulatory responses, and parts of CMC section of regulatory filings both US and OUS.

Part of a team responsible for analytical and formulation aspects of drug-eluting coronary stents used in the controlled delivery of pharmaceutical agents including support of commercial product as well as research and development. Scientific team leader responsible for multiple projects including the solid-state characterization of stent surfaces, synthesis and purification of polymers and small organic molecules as well as key manufacturing investigations. Team leader of Global Project Teams to ensure project deliverables according to established timelines. Experienced in the use of project planning tools such as Microsoft Project in order to track project deliverables. Responsible for the successful transfer of these processes to commercial manufacturing scale including all regulatory requirements.