Christian Phillips Email and Phone Number
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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.
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Senior Vice President, CmcInozyme PharmaBoston, Ma, Us
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Vp, Quality & ComplianceInozyme Pharma Dec 2022 - PresentBoston, Massachusetts, Us
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Head Of Pharma Sciences, CambridgeUcb Aug 2021 - Dec 2022Brussels, Be -
Sr Director Drug Product, Tech OpsUcb Apr 2020 - Aug 2021Brussels, Be
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Sr. Director Drug Product DevelopmentRa Pharmaceuticals Dec 2016 - Apr 2020Cambridge, Massachusetts, Us -
Independent ConsultantChristian Phillips, Llc Nov 2016 - Dec 2016Expert in all matters related to sterile drug product manufacturing operations, quality systems, quality agreements, audits, business development, FDA remediation/responses, regulatory compliance, and technical process design for aseptic formulation and fill finish.
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Vice President Site Commercial OperationsBrammer Bio Jul 2016 - Oct 2016Cambridge, Massachusetts, Us -
General Manager And Site HeadAmri (Albany Molecular Research Inc.) Dec 2015 - Jul 2016Albany, Ny, Us -
Senior Director Of Operations, Site HeadAmri (Albany Molecular Research Inc.) Aug 2011 - Dec 2015Albany, Ny, UsResponsible for developing and managing the Operating Plan for the AMRI Burlington sterile drug product fill/finish facility. Drive continuous improvement and compliance initiatives to foster scalable and sustainable operations. Provide routine technical oversight to find resolution to complex issues and path forward in a fast paced, highly regulated drug development setting. Manage P&L, staff development / training, safety, and capital budgeting.Core competencies at the AMRI Burlington site cater to the development and manufacture of complex drug product formulations (emulsions, suspensions, liposomes, viscous biopolymers, biologics, potents, oligos, controlled substance) across a number of injectible drug product platform technologies.
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Senior Director Quality AssuranceAmri (Albany Molecular Research Inc.) Jan 2010 - Aug 2011Albany, Ny, UsAppointed by AMRI executive management to restore / reform Quality Systems and compliance across site. Responsible for all Quality Assurance operations including cGMP investigations, Batch Record/Document review/approval, Incoming Raw Material Inspection, Internal Audits, Supplier Qualification, Batch Disposition, Training, Quality Engineering and Document Control. Successfully led and managed numerous CAPA initiatives across all quality systems resulting in the successful remediation and lifting of 2010 FDA Warning Letter.
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Director Process EngineeringHyaluron Contract Manufacturing Mar 2006 - Jan 2010Managed Process Engineering department consisting of a staff of 13 comprised of chemical and mechanical engineers, project manager, administrative assistant and a technical writer. Responsibilities included strategic development plan for process development, process design and development, batch record authorship, equipment specification and procurement, training, execution of GMP production, and project management.
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Manager Bioengineering / Process DevelopmentShire Pharmaceuticals 1994 - 2006Tokyo, Jp, Jp -
Manager Gene Therapy MfgTranskaryotic Therapies 1994 - 2006
Christian Phillips Skills
Christian Phillips Education Details
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Saint Michael'S CollegeBiology
Frequently Asked Questions about Christian Phillips
What company does Christian Phillips work for?
Christian Phillips works for Inozyme Pharma
What is Christian Phillips's role at the current company?
Christian Phillips's current role is Senior Vice President, CMC.
What is Christian Phillips's email address?
Christian Phillips's email address is ch****@****bal.com
What is Christian Phillips's direct phone number?
Christian Phillips's direct phone number is .781.270.7900 *****
What schools did Christian Phillips attend?
Christian Phillips attended Saint Michael's College.
What skills is Christian Phillips known for?
Christian Phillips has skills like Quality Assurance, Biotechnology, Aseptic Processing, Gmp, Pharmaceutical Industry, Technology Transfer, Quality System, Fda, Validation, Capa, Regulatory Affairs, Change Control.
Who are Christian Phillips's colleagues?
Christian Phillips's colleagues are David Thompson, Tanja Smith, Michael Gomes, Kevin O'brien, Nicole Peters, Di Chu, Ph.d., Christof Schulz.
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