Pharmaceutical, Medical Device Testing, Validation, Manufacturing, Biology, Microbiology, Immunology
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Fifteen years experience in Environmental Microbiology, QC Microbiology, and Microbial Genetics. cGMP experience includes Pharmaceutical Manufacturing of sterile liquids, lyophiles, powders and Combination Drug/Device products. Assisted scores of pharmaceutical and medical device manufactures to develop cleanroom validation, sterilization validation, and QC Microbiology programs.
Manage external drug product manufacturing vendor base to support Global portfolio.
Focus on sterile liquid drug products, lyophiles and powders.
Evaluated vendors to support drug products that cannot be delivered through internal capabilities/capacities.
Interact with global teams to understand and address project challenges.
Worked with Quality Assurance (QA) group to qualify vendors; serve as subject matter expert at site visits.
Worked with Qualified Persons to evaluate vendor readiness for compliance with EU cGMPs.
Based on project needs, directly coordinate external manufacturing activities, including batch records review/approvals and in-plant oversight.
Represent Supply Chain on Pharmaceutical Sciences Project Teams related to manufacturing of Biologics-based compounds.
Participate as active member of Transition Teams.
Transition early phase in-licensed candidates into supply chain.
Work as part of team to transition products into supply chain as a result of corporate acquisitions.
Manage all aspects of customers production requirements for all stages of drug and device development, Phase 0 through commercialization.
Responsible for preparation and management of project plans to meet production and financial milestones. Project activities include manufacture of small scale clinical trial to commercial parenteral fill/finish of small molecule, biologics and terminally sterilized drug / device combination products. Individual project contract values range in excess of $3 million annually.
Control scope and deliver project within agreed upon timelines and budgets. Provide timely notification to all functional resources contributing to projects. Define and monitor goals and objectives of project team members. Ensure that project activities are compliant to cGMP regulatory, and industry standards.
Consistently communicate project status and highlight critical path activities for all levels of resources and management among internal/external customers and vendors.
Select, support, and facilitate communication in order to develop effective cross-functional teams and multi department communication.
MS Word, MS Excel, MS Powerpoint, MS Infopath, MS Project, Quark, Adobe Acrobat, Adobe Photoshop, Adobe Illustrator