Experience

US WorldMeds

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Director, CMC Product Development

  • Apr 2018 - Present

  I and my team lead the CMC and nonclinical activities for new drug product development at US WorldMeds. Our efforts range from new product conception to technology transfer of existing drug products, and small molecules to biologics. I and my team lead the CMC and nonclinical activities for new drug product development at US WorldMeds. Our efforts range from new product conception to technology transfer of existing drug products, and small molecules to biologics.



Teva Pharmaceuticals

• Israel
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Director, Formulation Development

  • 2015 - 2017

  At Teva’s CIMA Labs subsidiary, I led a department of 11 Ph.D. and B.S. scientists developing solid dosage forms for drug repurposing, reporting directly to the VP of Drug Delivery. I formulated departmental objectives, led capital planning, and served on the Site Leadership Team.My team’s work began with product conception, developing formulations for feasibility PK studies. We optimized formulations and manufacturing processes to support clinical development through marketing approval, collaborating closely with commercial sites for process scale-up and technology transfer. I led departmental efforts for multiple drug delivery modalities.• Abuse-deterrent oral products, complex modified release products, combination products, and orally disintegrating tablets and wafers. My team gained extensive experience developing strategy and writing CMC sections for regulatory submissions, primarily INDs and NDAs but also including submissions in Canada, Europe and Japan. • I represented Teva CMC at multiple meetings with FDA and Health Canada. I contributed to the achievement of marketing approvals for abuse-deterrent hydrocodone VANTRELA™ ER (NDA) and Montelukast ODT (JNDA).• Represented Teva CMC at FDA Advisory Committee meeting for VANTRELA™ ER. • Resulted in 14-3 Advisory Committee vote for approval. FDA approval with unprecedented abuse-deterrent labeling: oral, intranasal, and intravenous routes of abuse.My team maintained a GMP suite for manufacturing of clinical trial materials. • Provided > 35 formulation variants for human clinical studies, for 5 development projects. Implemented departmental continuous improvement initiatives.• GMP Compliance: reduced audit observations yearly; 1 minor observation in most recent audit.• Quality by Design: increased the use of risk assessment, design of experiments, statistical data analysis, and structured report templates in department.



CIMA Labs

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Director, Analytical Development

  • 2011 - 2014

  Led a group of fifteen staff, reporting to the Senior Director, Analytical Development. I and my group developed and validated analytical methods to support GMP drug product development. These included methods for formulation characterization and performance; support of formulation design, process development, and process scale-up; release testing of clinical trial materials; and drug product stability.Provided leadership and direction to the Analytical Department.• Led the development and implementation of vision and mission statements for the Analytical department, gaining endorsement of the Sr. Director Analytical Development. • Chaired the Analytical Leadership Team. Chartered and guided sub-teams to establish best practices for method validation, method transfer, and evaluation of suspect data, among other things. Led group efforts to design, develop, and execute novel in vitro manipulation and extraction (“Category 1”) methodologies for characterization of abuse-deterrent opioid products.• Negotiated contracts and managed execution of protocols at contract laboratory, within allocated budget of about $1 million. Over 800 experiments and 3700 replicates were performed. Directed analytical chemistry contributions to the successful VANTRELA™ ER NDA.• Developed and internally validated a Level A IVIVC in collaboration with a CRO.• Led a cross-functional team to develop drug substance, drug product, and excipient specifications.• Authored analytical and stability sections, Category 1 abuse-deterrent sections, and co-authored Summary of Biopharmaceutics (with Clinical Pharmacology).• Directed analytical technology transfer to the commercial manufacturing site.



CIMA Labs

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Associate Director, Analytical Development

  • 2006 - 2010

  I led a team of 12 staff, directing analytical method development, validation, and stability activities to support GMP drug product development and scale-up. I managed all analytical chemistry support for introduction of six new products into the clinic.• Orally disintegrating tablets, extended-release abuse-deterrent opioid tablets, oral transmucosal tablet.In collaboration with team members, I spearheaded multiple business process enhancement initiatives.• Conducted Analytical customer focus surveys, leading to actionable departmental objectives.• Collaborated with Project Management to bring Quality Risk Management training course in house, facilitating site-wide culture change for risk assessments.• Led team overhauling reference standard procedures, resulting in new departmental SOPs.• Served on site-wide New Product Selection team. Identified novel product concept for oral transmucosal delivery of a poorly soluble drug.



Merck

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Research Chemist / Research Fellow / Senior Research Fellow

  • 1998 - 2006

  I worked in teams with formulation scientists, pharmaceutical chemists, process engineers, safety assessment and regulatory scientists, and clinicians to achieve product development goals. I mentored B.S., M.S., and Ph.D scientists to develop and validate analytical methods to support GMP drug product development.Some highlights of my Merck career include:• Led all analytical activities supporting approved NDAs for FOSAMAX Oral Solution and FOSAMAX Plus D: methods development and validation, stability analysis, and justification of specifications. • Guided authoring of analytical sections for Januvia NDA/WMA submissions.• Served on a cross-site team that designed a new interface for technology transfer. Resulted in a new organization bridging early development and commercialization.• Internal Development Team leader: led pharmaceutical R&D teams responsible for formulation and process development for a Phase 1 sterile oncology product and an orally disintegrating tablet.• Conducted CMC due diligence (analytical and stability) for a successful licensing agreement with a Japanese pharmaceutical company.• On-site Scientist Exchange at Banyu Pharmaceuticals: Built working relationships between analytical groups. Enrolled in Japanese language course to enhance communication and cultural awareness.• Made significant contributions to further understanding of drug degradation mechanisms, in collaboration with other Merck scientists. Resulted in multiple peer-reviewed publications.



Purdue University

• United States
• Higher Education
• 700 & Above Employee

• National Science Foundation Postdoctoral Fellow

  • 1995 - 1998

  NSF Postdoctoral Felllow.Investigated gas-phase ion-molecule chemistry, using a flowing afterglow reactor coupled to a triple quadrupole mass spectrometer. Characterized structure, reactivity, and thermochemistry of negative ions of carbenes and biradicals. NSF Postdoctoral Felllow.Investigated gas-phase ion-molecule chemistry, using a flowing afterglow reactor coupled to a triple quadrupole mass spectrometer. Characterized structure, reactivity, and thermochemistry of negative ions of carbenes and biradicals.