As the PTSI Vice President of Manufacturing and Quality, Michael is responsible for providing consulting services to Pharmaceutical, Biotech, and Cell Therapy companies by providing scientific quality standard guidance for the design, performance, monitoring, auditing, and reporting for clinical trials and mentoring biopharmaceutical teams in the development of high-performance work teams.

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Biopharmaceutical professional with over 25 years of extensive experience in all phases of Manufacturing, Facility Design and Quality System implementation. Capable of advancing products through full lifecycle utilizing a mindset focused on implementation of phase appropriate Quality Systems. Collaborative leader with ability to effectively communicate, analyze complex issues and focus on resolution.

Experienced with direct interaction with FDA and other regulatory agencies during inspection of Phase I, II, II, and commercial manufacturing facilities, technical support, validation, quality system implementation, commercialization, and pilot plant operations.

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Following 20 years in protein manufacturing at Amgen, Michael has transitioned into the Cell Therapy space by holding various leadership roles within Atara’s T-Cell Therapy network. Notably, he oversaw mechanical completion and commissioning of the Atara T-Cell Manufacturing facility in Newbury Park, California. This state-of-the-art facility provides process development, quality control as well as T-Cell, CAR T and viral vector manufacturing capability within one building.  

  

Within Amgen, he was responsible for design/ commission and licensure of the Neupogen and Neulasta purification areas at the Juncos, Puerto Rico facility brought online in early 2000s. 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.

 

• Business Lead for URS Development in the Neupogen Plant Detailed Design Process. Experience with extremely detailed URS documents relating to Process Control Systems.

• Part of Juncos, PR Neupogen/ Neulasta DS Facility Team during Conceptual Design. Well-versed in design reviews and submittals.

• Responsible for Neupogen Purification Areas Start-up and Commissioning. Experienced with S88 Architecture and working in tandem with Automation Engineers.

• Extensive experience in validating plants and systems including upstream, downstream, clinical, commercial, process transfers, etc.

• Broad experience in MFG Operational Readiness.

• Represented Production/ MFG on several efforts.

• Firsthand experience with agencies in both PAI and periodic inspections. 

 

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

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