Strategic Leadership & Executive Management:

• Provides strategic direction, operational leadership, and organizational oversight across complex biopharmaceutical programs.

• Responsible for providing consulting services to Pharmaceutical, Biotech, and Cell/Gene Therapy companies.

• Assist clients in developing execution strategies in support of design, build, commissioning, operation readiness and validation.

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Biopharma Manufacturing & Technical Operations:​

• Experienced leader (30+ years) in Biopharma, Biotech, Gene Therapy, Viral Vector, Cell Therapy, CAR T, mRNA, and Vaccines.

• Direct end-to-end support for manufacturing sites, including Detail Design, Construction, MFG Operational Readiness, CQV, PAI readiness, and FDA/ EU Licensure.

• Led large-scale biopharma operations teams, including a 75-member manufacturing team at Amgen’s Neupogen/Neulasta facility in Juncos, PR

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Regulatory Compliance & Inspection Readiness:

• Deep experience with FDA audits, EU/ QP Certifications, PAI Inspection Readiness, and regulatory remediation for both internal teams and client operations

• Ensures compliance through QA, QC, CQV, GMP Tech Writing, and Deviation/ CAPA oversight

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Program & Project Leadership:​

• Directed greenfield construction and operational readiness for the Purification areas of the $300M Neupogen/Neulasta project at Amgen Puerto Rico, overseeing Design, Build, and CQV of multiple GMP within 3.0 years

• Following this ex-pat assignment, he returned to a global manufacturing role where he advanced a network of operational excellence professionals and led global training development for Amgen operations.

• During this period, he led an effort to develop a series of immersive multiweek training classes partnered with the National Institute for Bioprocessing Research (NIBRT) in Dublin, Ireland. Amgen utilized this training curricula to develop subject matter experts on various unit operations throughout its global network

• Additionally, he oversaw mechanical completion and commissioning of the Atara T-Cell Manufacturing facility in Newbury Park, California.

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Tech Transfer, & Commercial Readiness:​

• Worked with partner groups to ensure successful tech transfer of Neupogen/Neulasta from Thousand Oaks, Ca to Juncos, PR.

• Provides expertise in tech transfer, and commercial readiness across multiple product modalities in partnership with our qualified CDMOs

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Cross-Functional Technical Consulting:

• Guides teams, delivering expertise in biopharma, engineering, manufacturing, process development, QA, QC, reliability centered maintenance/ CMMS, CQV, and client liaison functions

• Provides technical oversight and solutions for complex operational, engineering, and regulatory challenges across the biopharmaceutical sector

 

Michael has a BA in Biology from the University of California, Santa Barbara.