Robert Markovich Email & Phone Number

San Diego, Ca, Us

San Diego, California, 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.

San Diego, California, Us

San Diego, California, Us

San Francisco, California, Us

Led development program group activities and analytical teams (US and international site labs) for early through late stage development API/Drug Product R&D for Human Rx Biological products (proteins and PEGylated Proteins), PEGylated small molecules, and medical devices. Cross-functional team lead/support for multiple programs, development/implementation of program strategy and specification development council activities. Technical lead for drug product development projects (pre-phase I to commercial filing), process development/optimization/scale-up [up stream process (USP), down stream process (DSP) and conjugation], CMO/CRO activities, fit-for-purpose in-process/release methods, specifications, and technology transfer for raw materials, intermediates, API, and finished products. Author/reviewer for regulatory CMC sections of manufacturing, process, characterization, analysis of intermediates, API and drug product sections for US/EU submissions as well as reviewed/contributed to clinical/non-clinical sections. Led implementation of quality systems, SOPs, system/process audits, supplier/CMO audits, investigations/CAPAs. Responsible for hiring/mentorship/development of staff/managers, capital equipment, budget, laboratory compliance, and organization design/integration.

Lead Consultant/Subject Matter Expert for US consent decree activities which established Quality Management Systems (QMS), SOPs, technology transfer, analytical and microbiological method validation/ transfer, specifications, process validation, cleaning validation, laboratory/manufacturing operations, and Investigations/CAPAs, product complaints, analytical, microbiological, specifications, training, metrics, etc.

Rahway, New Jersey, Us

Led commercial drug product activities for multiple programs associated with EU Harmonization & Compliance, Latin America commercial product manufacturing site re-alignment, etc.; Led staff of 3 groups responsible for multiple commercial API and drug product projects including analytical methods development/validation; analytical technology transfer; analytical methods troubleshooting/ problem solving, laboratory investigations, regulatory responses, and review CMC sections of new and existing regulatory submissions for commercial drug products.

Rahway, New Jersey, Us

Led development/commercialization department for several groups (~20 scientists) & additional staff (~30 scientists) under a matrix management organization supporting US and international manufacturing sites. Established/Led analytical sciences department to provide technical support to all commercial site laboratories (multiple worldwide sites) and third-party manufacturing sites for APIs and drug products including all compliance activities (development, transfer, process validation, commercialization). Senior Management Reviewer for submissions/responses for CMC sections NDA/MAA/BLA for World-wide submissions (US/EU/RoW). Led global commercial API and drug product activities for biological molecules, small molecules, inhalation products, OTC, and Animal Health; commercial process development/optimization/scale-up and transfer including up stream and down stream related activities; reference standards; methods development/validation; technology transfer; methods troubleshooting, manufacturing/laboratory investigations; leachable/extractable studies; cleaning methods, audits, inspection readiness, development/roll-out of company-wide Quality Management Systems (consent decree). Responsible for group expansion from 20 to 65 staff, equipment, compliance, budget, and organization design/integration as well as leading/mentoring staff development.

Kenilworth, New Jersey, Us

Section Leader - 2000 to 2003: Principal Scientist 1997-2000: Associate Principal Scientist 1995-1997: Senior Scientist 1991-1995:

Postdoctoral Research Assistant, Department Of Medicinal Chemistry/Pharmacognosy

Ph.D., Industrial And Physical Pharmacy, Pharmaceutics

Bachelor Of Science, Chemistry Acs Approved

Physics And Chemistry