Michael Marcos, Ms, Mba Email & Phone Number

Kenilworth, Nj

• Served as Bioanalytical team leader in cross functional product development team for insulin biosimilar program (MK-1293) and was responsible coordinating and aligning internal and external immunogenicity testing and data transfer critical for successful NDA submission and regulatory approval• Worked closely with Financial and Procurement teams to align on sourcing strategy to forecast outsourcing spend and identify opportunities for savings and supplier synergies• Contributed to successful and timely review of NDA and BLA filings for diabetes, oncology, and acute hospital acute care programs in US and EU• Managed timelines, deliverables, and budget for regulated bioanalysis and method validation at external partners (CROs) for biologics and vaccines pipeline on programs ranging from preclinical candidate to Phase 3 as part of Strategic Operations and Immunoassay Collaborations groups

West Trenton, Nj

•Successfully developed, transferred, and validated pharmacokinetic and anti-drug antibody assays to meet client’s needs and support their drug development pipeline•Analyzed human and animal samples in a regulated environment to support clinical and pre-clinical trials for clients ranging from biotech to large pharma

West Point, Pa

•Supported various groups in Merck Research Laboratories for reagent and material shipping•Processed serum and plasma samples obtained from animals to support toxicokinetic and pharmacokinetic studies for preclinical testing.

Greater Philadelphia Area

•Developed and validated analytical assays to support in-process testing and stability characterization of bulk drug product and drug substance of biologic medicines•Performed routine analytical testing in a regulated laboratory environment

Camden, Nj

•Responsible for expansion of fibroblast and lymphoblast cell lines for DNA extraction and cryopreservation•Established and transformed lymphoblast cell lines using Epstein-Barr virus from whole blood submissions•Established primary fibroblast cell lines from both human and animal biopsy submissions

Executive Master Of Business Administration, Finance

Ba, Biology

Master’S Degree, Biology