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<pre>Array ( [var] => cut_url ) </pre> Resume for Sharon B. for Project Manager / Biotechnology & Pharmaceuticals in Raleigh, North Carolina. Search More Resumes for Project Manager on Resumark.com #OYKASNS8U
 

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Resume for Sharon B. for Project Manager / Biotechnology & Pharmaceuticals in Raleigh, North Carolina




Occupation: Project Manager Industry: Biotechnology & Pharmaceuticals
Country: United States City: Raleigh
State: North Carolina ZIP: 27616



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Sharon L. B., PMP Sarazen Drive, Clayton, NC Profile available on LinkedIn Email: Summary I am an outgoing, driven and collaborative project manager with + years of proven successes in product development, commercialization, and transfer within the pharmaceutical and medical device industries. I am looking for a challenging management position in an organization with the willingness to foster professional growth to my full potential. PMP Certified Feb PMI certification . PROFESSIONAL EXPERIENCE ETHICON, Inc. R&D PROJECT MANAGER New Product Development July present KEY PROJECT MANAGEMENT ACCOMPLISHMENTS * Lead the development and commercialization of DERMABOND ADVANCEDTM Topical Skin Adhesive a MM/year product intended to replace the existing Dermabond brand and grow ~% per year * Lead the US approval and launch of ETHICONTM OMNEXTM Surgical Sealant a PMA product, the first Cyanoacrylate chemistry approved in the US for use inside the body * Lead the evaluation of the worldwide search for sealant technologies; conducted evaluations within a one year period using a rapid "GO/NO GO" strategy and recommend for merger, license or acquisition KEY SKILL SETS and RESPONSIBILITIES * Project Initiation and Planning + Development of high level project plan/strategy, scope and deliverables + Development of detailed Gantt charts, and identification of needed resources and budget requirements + Identification of critical and nearcritical paths, project risk assessment and potential mitigation plans * Product Lifecycle Management + Management of new product development lifecycle from concept to commercialization and DHF owner + Collaboration with commercial group from development of TPP and customer requirements to product validation and launch support + Management of R&D product development, including product requirements, analytical methodology requirement, and final inprocess/finished product specifications + Collaboration with operations group from prototype equipment development to final PQ and launch build up + Collaboration with Regulatory Affairs on requirements for FDA submission/CE Notifications + Management of labeling and graphics development and approval * Project Implementation/Execution and Metrics + Management of cross functional teams based on project plan in a matrix environment + Management of realized risks or new opportunities and development/communication of action plans + Management/update of project timeline based on progress MS Project + Tracking of project budget or accruals and approval of expenses + Establishment of project milestones and team celebrations at critical milestones and closeout. * Sponsor, Stakeholder, and Boardlevel Management + Establishment of project plan and gaining buyin and alignment + Identification of key influencers and decision makers anticipate concerns and prepare solution scenarios + Develop and deliver presentations with clear and compelling messages without being overly complex + Develop and deliver presentations as required for project phase reviews and toll gates * Team and CrossFunctional Management + Team Collaboration Leading team development through the project lifecycle, from project kickoffs through tactical project execution to final lessons learned + Cross Functional Collaboration Management of a diverse crosssection of members, including: o o R&D o Regulatory o Marketing o QA/QC/Sterilization o Operations o Clinical Affairs o PreClinical Affairs o Medical Affairs o Analytical o Intellectual Property o Supply Chain o Procurement + Multisite Collaboration Virtual teams Management of teams in multiple geographic areas, including North Carolina, New Jersey, Georgia, and Puerto Rico * Technical/Scientific Experience Base + Scientific experience and training to understand and respond to complex technical issues or provide review and approval of technical protocols and reports + Understand GMP&;s and development processes from feasibility through qualification/validation for both pharmaceutical and medical device industries + Experienced in design control to support quality and regulatory requirements US/OUS Novo Nordisk Pharmaceutical Industries, Inc. Project Manager New Product/Process Transfers April July KEY PROJECT MANAGEMENT ACCOMPLISHMENTS projects in total * Successful transfer of two new insulin products from Denmark to Clayton, NC site weeks ahead of schedule * Successful transfer and scale up of seven existing products to new formulation / filling lines within Clayton, NC * Gained experience and implemented Six Sigma projects in Process Excellence/Lean Manufacturing Project Manager Responsibilities * Presentation of detailed project plans to stakeholders to allow transition of project from planning to execution * Initiate and provide leadership for a diverse crossfunctional project team to achieve the goals of: + Implementing new sterile liquid products on existing formulation/aseptic filling line vial line + Implementing new and existing sterile liquid products on new formulation/aseptic filling line cartridge line * Identify and lead cross functional resources and responsibilities for projects * Develop, gain agreement and maintain timeline/milestones for all product transfer projects MS Project * Prepare and manage budget, including formulation, filling/laboratory equipment and contract resources * Develop and present project updates, challenges and recovery plans to senior management * Manage the project via established team meetings with resources, identifying road blocks and competing priorities, managing changes and creating mitigation plans as needed * Ensuring cohesiveness/positive attitude of team by open and honest communication, listening/responding to frustrations, providing solutions to roadblocks and celebrating major milestones * Collaborating with Regulatory offices, both in US and Denmark to identify regulatory approval needs for both US and restofworld submissions Product Development Responsibilities * Collaborate with Denmark Manufacturing Development group to gain expertise on new products * Draft formulation process coordinating product limitations and restrictions with existing equipment and supply * Design experiments of draft formulations via placebo or WFI tests to maximize formulation process * Perform full scale test batches, confirming the formulation and filling processes meet both process limitations formulation and filling and chemical validation requirements * Train site personnel on overall product knowledge, formulation, filling, and validation processes * Lead investigations for all unexpected data observed during PV, providing root cause analysis, impact to validation and batch quality, and corrective/preventative action * Provide inprocess, finished product and stability data to regulatory affairs to support regulatory filings * Act as technical lead for all internal and external audits regarding new and existing product transfers Other Novo Nordisk Roles TITLE: Product Development Engineer, AerX inhaled insulin Conceptual Design Project Capital Projects TITLE: Process Improvement Engineer Process Engineering/Operations Excellence TITLE: Manufacturing Supervisor Aseptic Filling TITLE: Quality Assurance Specialist Quality Assurance EARLY CAREER ROLES Bertek, Inc. site layoff QA Supervisor Clinical Product Development Pharmanetics, Inc. Quality Engineer Automatic Liquid Packaging, Inc. Stability Program Coordinator ALPharma, Inc. Stability Research Scientist Nalco Chemical, Inc. Cooperative Education Student EDUCATION Illinois State University, BS in Chemistry, ACS Certified PMP Certification, PMI Certification

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