Robert Markovich
Executive Director, Analytical & Characterization Development @Halozyme, Inc.
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WORK HISTORY
Executive Director, Analytical & Characterization Development @Halozyme, Inc.
San Diego, CA, US
Analytical technical and strategic lead for all analytical development and characterization activities for rHuPH20 drug substance platform, ENHANZE Alliance partnerships, and commercial drug products (HYLENEX, Xyosted, Tlando, etc.) including the development and implementation of product test methods to ensure effective control strategies, specifications, and CQA assessments in support of product life-cycle management as well as support to regulatory filings. Author/reviewer for regulatory CMC sections of manufacturing, process, characterization, analysis of intermediates, API and drug product sections as well as requests for information for world-wide submissions. Work/collaborate with cross-functional teams in product development, product life-cycle activities, and other CMC related departments (manufacturing, quality, regulatory, etc.), external contract manufacturer/test laboratories, and partners. Responsible for hiring/mentorship/ development of staff/managers, capital equipment, budget, laboratory compliance, and organization design/integration.
EDUCATION
Purdue University
Bachelor of Science, Chemistry ACS Approved
Purdue University
Postdoctoral Research Assistant, Department of Medicinal Chemistry/Pharmacognosy
Illinois Institute of Technology
Physics and Chemistry
Purdue University
Ph.D., Industrial and Physical Pharmacy, Pharmaceutics
SKILLS
ABOUT ROBERT MARKOVICH
Global pharmaceutical leader with experience in CMC product development, analytical development, quality control/assurance, process development, and formulation activities for intermediates, API, and drug product including biological molecules, small molecules, and inhalation products/devices related products for various therapeutic categories (e.g, oncology, immunology, auto-immune, cardiovascular, anti-inflammatory, antibiotics, etc.). Experienced in leading groups (US and international sites) for all aspects of CMC from pre-clinical, late stage development, technology transfer, commercialization, launch, and Life-Cycle management projects for small molecules and biological products including process development/optimization/validation, fit-for-purpose in-process/release/stability methods, API characterization, clinical supplies support as well as all activities with contract manufacturing/research organizations (CDMO/CRO) throughout all phases of development to commercialization. Experienced in world-wide regulatory CMC submission activities from early phase through commercial regulatory submissions including significant Rest of World submissions experience as author/reviewer/approver of CMC sections, question responses, contributor/reviewer of clinical/non-toxic sections, pre-submission quality packages, and health authority meeting activities. Responsible for staffing, compliance, budget, and organization design/integration as well as leading/mentoring staff development.
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