Driving global quality excellence for a leading multinational biotechnology company, pioneering the development of groundbreaking TCR bispecific immunotherapies for cancer, infectious, and autoimmune diseases, and delivering innovative treatments to patients with critical unmet medical needs.

Provided strategic leadership for Teva’s innovative and biosimilar biologics R&D programs from pre-clinical through clinical production to commercial approval. Directed R&D QA through multiple successful Investigational New Drug (IND) and Biologics License Application (BLA) submissions, ensuring robust regulatory compliance and efficient manufacturing processes.Key Achievements:Spearheaded the development of well-characterized and efficient manufacturing processes and analytical assays, facilitating successful technology transfer from development to commercial scales.Ensured readiness for Pre-Approval Inspections (PAI) and other regulatory inspections for commercial sites.Managed QA units responsible for product release from in-house and Contract Manufacturing Organizations (CMOs) for GLP Toxicology, Phase I-III clinical trials, and process-performance qualification (PPQ).Led the construction and operation of a cGMP Biologics Manufacturing Facility featuring state-of-the-art disposable bioreactor technology, Cell Banking, and Fill Finish operations.Maintained GMP compliance for all quality systems at facilities in the US and Israel.Extensive experience managing Drug Substance (DS) and Drug Product (DP) CMOs internationally, including in the US, EU, and South Korea.Transitioned a clinical cGMP manufacturing facility to a commercial cGMP operation.Recognized as a Subject Matter Expert (SME) in biologics manufacturing, providing QA consulting for a large-scale Teva commercial biologics manufacturing facility under construction in Ulm, Germany.

Responsible for all aspects of GMP Quality for Teva Biopharmaceuticals USA, part of Teva Pharmaceuticals Innovative Research and Development. Quality oversight for multiple products in various phases of early to late phase clinical development, including in-house cGMP biologic production as well as QA oversight of contract manufacturing organizations and contract research organizations. Led quality assurance on an aggressive schedule with successful re-start of cGMP manufacturing for clinical biologic drug substance manufacturing, including ensuring qualification of facilities and equipment, cGMP training of operators, and led improvements to the quality culture on site. Rapidly eliminated massive quality record backlog present on hiring. Managed quality aspects of decommissioning and relocation of cGMP manufacturing and lab space from Rockville, MD to West Chester, PA. Participant in multiple audits for laboratories, bulk drug substance, fill/finish, and solid oral dosage facilities globally. As Subject Matter Expert for biologics quality, participant in Quality Assurance design review and approval for new state-of-the- art cGMP bulk biologics and fill-finish facilities constructed by Teva in West Chester, PA. Facility brought from "shell space" to first GMP Production Start in 18 months. Supported creation of multiple IND and a BLA submission through to approval.

Taught a two day course 2x per year on Risk Based Validation for Biopharmaceutical, pharmaceutical, and medical device industry professionals.

As a cGMP compliance expert, I led the development of regulatory compliance strategies, internal audits, and coordination of regulatory agency and partner audits and inspections. I spearheaded “pressure test” preparations for regulatory audits, ensuring successful outcomes.Key Achievements:Directed the completion of validation work and performed gap analysis and mitigation for Amgen’s Biovex acquisition in Woburn, MA, and Abingdon, UK.Ensured adherence to validation and filing timelines, culminating in the successful launch of IMLYGIC™ (talimogene laherparepvec).

Oversaw the success of concurrent multiproduct commercial manufacturing at one of the world’s largest biopharmaceutical facilities, with 180,000 L of production bioreactor capacity. During my leadership, the plant received Amgen’s “Best Plant” award in 2012.Key Responsibilities and Achievements:Managed new product introductions and led the rapid resolution of significant manufacturing issues to minimize impact.Played a key role in all site regulatory inspections and regulatory filing submissions, RFIs, and reviews.Built and developed a high-performing, multilevel team that delivered quality results on aggressive timelines.Conducted technical investigations and drove corrective/preventative actions (CAPA) and major improvements.Led the team responsible for writing the manufacturing sections of the BLA/ other submissions and answering RFIs for multiple products.

Quality Lead: Led conversion of ARI site to concurrent multiproduct manufacturing and led all quality and validation through two new product introductions and a major facility modification. Led the development of segregation and changeover practices which enabled concurrent multiproduct manufacturing on site of over 100 lots per year, wrote the FDA submission for the conversion of the site to multiproduct operation, and presented multiproduct operating controls successfully to multiple regulatory agencies.Process Validation: Led senior level process validation engineers and contractors responsible for all process validation at Amgen's Rhode Island biotechnology facility and contract manufacturing process validation oversight for Amgen's protein products at multiple CM facilities in the US and Europe. Led over a dozen successful drug product or drug substance conformance lot and new product introduction PV campaigns from tech transfer through submission. Participant in many successful regulatory agency filings and inspections. Led all validation for implementation of major process changes into the ARI facility. Active participation in multiple BLA and other regulatory agency submissions.

Responsible for start up performance qualification (CIP, SIP, EM, Washers, Autoclaves, Utilities) and process validation at one of the world’s largest biopharmaceutical manufacturing facilities. Defined site validation philosophy and many site operating practices. Managed a multilevel team of validation engineers who oversaw over 30 contract validation staff from two validation contract companies. Plant was constructed and validation completed in record time for a plant of this size, and FDA approved following a very successful PAI. Actively participated in successful FDA and EMEA audits. .

Coordinated and managed IQ, OQ, SIP PQ, process validation, and change control equipment validation activities in a large scale retrofit construction and remodeling of a biopharmaceutical manufacturing facility. Developed site validation philosophy and performed documentation generation and review support for validation protocols, reports, master plans, and SOPs. Conducted gap analysis on and participated in defense of validation packages for successful FDA PAI and EMEA audits. Project met critical supply shortage for product. (Enbrel ™)

Validation Specialist: Contract validation project management, auditing, and support for client companies, including:Stryker Biopharmaceuticals, Hopkinton, MA and Lebanon, NH. (September, 1999 to February, 2001).Wrote and executed equipment qualification and validation protocols. Wrote steam quality-testing SOP, assisted with EMEA audit defense and assisted with development of cleaning and sterilization validation philosophy. Genetics Institute, North Andover, MA.(current Pfizer site) (May, 1999 to September, 1999). Wrote and executed validation protocols for equipment, utilities, CIP, and SIP.

Responsible for identification of shortcomings in existing validation packages as well as drafting and executing IQ, OQ and PQ protocols and generating reports for chromatography processes, incubators, cold rooms, freezers, utilities, SIP and CIP of equipment and computer validation. Assisted with contamination investigations in production suite. Assisted with site preparation and gap analysis for internal, MCA, and FDA audits. Supervised validation projects, managed and trained temporary validation employees. Participated in FDA PAI and MCA audits. Interacted with FDA and internal auditors, answering questions and presenting cleaning validation and other validation work. Gained expertise in equipment qualification, cleaning and SIP validation. Revised Cleaning Validation Master Plan.

Research biologist in a cGMP biologics pilot plant. Responsible for operation of bioreactors, homogenizers, centrifuges, and purification equipment, including troubleshooting, contamination investigation, and problem solving. Gained experience with SIP, CIP, bacterial, mammalian, fungal, and insect cell culture as well as purification.