Name:
Robert Jason Markovich
Country:
USA
City:
Owens Cross Roads
State/Province:
AL
ACS Member:
Member
Local Section:
L425,North Alabama
International Chapter:
Technical Division Membership:
D502,Analytical Chemistry Division
Technical Division Membership Emeritus:
Subdivision Member:
G02,Chromatography & Separation Subdivision
ACS Activities:
Company/Institution Name:
Nektar Therapeutics
Career Stage:
Professional
Research and Special Interests:
Experienced analytical professional responsible for leading analytical teams for the technical support of API/Drug Product R&D as well as commercial drug products including Human Rx, Over-the-counter, Animal Health, and Biological products. Extensive experience related to the technical support of drug product development, drug product commercialization/life-cycle activities, drug product manufacture site transfers, analytical method troubleshooting, drug product investigations, API & drug product analytical methods development/validation/transfer, leachable/extractable methods/studies, analytical cleaning methods, customer complaint/counterfeit sample investigations, manufacturing particulate investigations, and unknown peak investigations. Extensive experience related to Chemistry, Manufacturing, and Controls (CMC) of API and drug product sections for drug products including CMC review for worldwide drug product submissions (new product filings, registrations in new markets, filings due to changes, etc.); responses to analytical related Health Authority questions; and new drug product introduction to commercial sites including NDA, MAA, JNDA, Latin America region, Asia region and Rest of World submissions.
Area of Expertise:
Analytical
Years of Expertise:
21-25