Global R&D Lead Microbiology is an R&D leader who will be responsible for delivering the vision and strategy for the PCH Microbiology team which is consistent with the Global R&D Analytical Sciences & Microbiology strategy. Additionally, this leader will be responsible for maintaining the Microbiology operating budget as well as perform the role of site Bio-Safety officer. They are also accountable for site environmental and water testing as well as leading the site Laboratory Operations Committee to ensure the all of these areas are in compliance applicable FDA and local governmental standards.
Lead the microbiological team consisting of 5 FTEs and contractors
Leads the development and validation for Microbiological methods that supports the global PCH portfolio including but not limited to probiotics and preservative systems
Acts as the Richmond site Bio-Safety officer and as such works with EH&S to ensure that the site, with regard to microbiology, is compliant with all Federal, State and local laws
Accountable for environmental and water sampling, testing, data analysis and trending across the site including the GMP manufacturing facility to ensure that the site is compliant to all applicable standards
Leads the identification and quantitation of unknown and objectionable organisms that are encountered during environmental and water testing
Responsible for authoring annual reports on Environmental Monitoring and Water Quality as part of the Richmond Site EH&S report
PCH microbiology thought leader and the primary responder for microbiological questions from global PCH sites including Global R&D and Manufacturing sites and is responsible for responding to all microbiological questions, whether in person or by written response, posed by global Boards of Health including the FDA on any PCH submission or filing
Supports innovation for PCH Core Brands and New Business Initiatives across Health and Wellness
Leads the Laboratory Operations Committee which oversees all of the laboratories in the Richmond Global R&D facility, including the GMP facility, to ensure that the laboratories are in compliance with all relevant FDA and local government standards
Acts as a consultant for microbiology related policy initiatives and decisions for global PCH to ensure that PCH is in compliance with all applicable microbiological standards
Acts as the PCH liaison to the microbiological community within the Pfizer enterprise and external to the company through various professional organizations
Demonstrable OWNIT behaviors. Inculcatesa positive, respectful,inclusiveculturethroughtrustand demonstrated leadershipbehaviors,ethicsand integrity
Qualifications
PhD with at least 7 years of post-doctoral and/or industrial experience in either the Rx or Food Industry
Expertise in multiple regulatory categories including Drug, Food, DSHEA, Cosmetic and Device is preferred
Demonstratedbusiness acumen, problem solving capability, strategic thinking, operationalknowledgeandanability to trackandmanage a highlevel of detailiscritical to be successful inthisrole.
Demonstrated leadership in microbiological matters across the Health & Wellness Organization, withproven ability to navigate culturaldiversityand leverage multipleperspectives.
DemonstratedEmotional intelligence (EQ) andability to leadin a complex and matrixed environment.
Values Diversityandis culturally sensitivewithstronginterpersonal skills and excellent stakeholder engagement skillsand experience.
Developstrustand positive relationships and works well in a team environment. Ability to resolve conflict and move forwardinanobjectiveand positive manner.
Assumesaccountability.
Ability and eagerness to challenge status quo in an appropriate manner, acts decisively.
Proven communicationand negotiation skillsat multiple organizational levels.
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