Clyde Schultz Email & Phone Number

Experienced Global Director with a demonstrated history of working in the pharmaceuticals industry. Skilled in Medical Devices, Biotechnology, Cell Culture, Healthcare, and U.S. Food and Drug Administration (FDA). Strong business development professional with a Doctor of Philosophy (Ph.D.) focused in Microbiology and Immunology from University of Maryland.

Listed skills include Research and Microsoft Excel.

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  Director

  Celgene

  Feb 2008 - Oct 2019 - Greater New York City Area

  Responsible for establishing quality assurance requirements, processes for biological products, solid oral dosage formulations and for sterile (cytotoxic) parenteral products worldwide. I am also responsible for providing quality assurance oversight, management and expertise associated with aspects in testing, manufacturing operations and deviation/investigation resolution. I am the main contact for regulatory agency inspections (FDA, EMA, TGA, etc.) associated with biological products and microbiological inquiries. I serve as the Subject Matter Expert (SME) on all microbiology issues for the company and its subsidiaries.1) Established and performs and/or manages the following responsibilities associated with clinical and commercial biological and solid oral dosage products:a) Approval of quality specification for raw materialsb) Batch data review for solid oral and parenteral products (analytical, stability, microbiological, and virology). c) Review and approval of investigations, change control, and protocols related to microbiology and biologics. These methods are for testing, technology transfers, stability, cleaning, and sterilizationd) Manages Budgetsh) Perform cGMP audits and investigations at sub-contractors.i) Perform compliance audits on companies that Celgene may wish to acquire.(j) Quality Assurance Technology Transfer lead for sterile products, sterile cytotoxic products, biological products and solid oral dosage formulations. i) In the realm of biological products I was the quality assurance representative on the team responsible for developing Celgene’s lead biological product. This included technology transfer from Phase 2 to Phase 3. I was directly responsible for assisting in batch records construction for drug substance and drug product lots. I was also directly responsible for laboratory qualifications and protocol review and approval. All this work was reviewed in a limited way by FDA.

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  University Of Maryland

  Microbiology And Immunology