Christian Phillips Email & Phone Number

Experienced Leader with broad technical expertise and thorough understanding of pharmaceutical development and GMP manufacturing (parenterals and combination device products, DHF), global drug product supply chain, quality systems, plant operations and business administration / OpEx principles for successfully managing cGMP operations, and technical Lead for all onsite audits. 25+ years of progressive experience in biotechnology and pharmaceutical process development, tech transfer and cGMP manufacturing of drug substance and sterile drug products including small molecule, peptides, biologics and gene therapy / viral vector platforms. Subject matter expert in the development and manufacture of sterile drug products and the custom design and procurement of facilities/equipment that bring forth compliant and cost effective solutions for the clinical and commercial manufacture of sterile injectibles. Sterile Drug Product specialty areas of expertise include GMPs, Visual Inspection Program development/design, Aseptic Process Design / Qualification and Best Practices, Risk Assessment, GMP Investigations, Cross Contamination Control, FDA / EMA Inspection Readiness and Remediation, CMO Business Administration, and Leading large multifunction teams through complex challenges and Global health authority interactions. Head of Drug Product for commercial development of Zilucoplan (macrocyclic peptide) daily self administered PFS combination product leading all of cmc drug product development with focus on control strategy development, supply chain, device design and DHF development and compliance, human factors studies, risk management and commercial launch readiness. Also responsible for the uninterrupted supply of finished goods supporting several global trials. Primary oversight and responsibility of all external drug product primary and secondary packaging CMO’s and commercial PPQ strategy and execution. Head of Quality (subsequently appointed General Manager and Site Head) of sterile fill finish CMO. Successfully led complex remediation of FDA Warning Letter and subsequent return to profitability at AMRI Burlington aseptic fill/finish facility.

Listed skills include Quality Assurance, Biotechnology, Aseptic Processing, Gmp, and 28 others.

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  Saint Michael'S College

  Biology