Senior Scientist - Biologics and Vaccines Analytics job in West Point
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|Employer:|| Merck & Co.|
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century . Merck's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. |
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
Biologics and Vaccines Analytics (BVA) is responsible for the commercialization of vaccine and biologic analytical techniques from Phase III through launch and transfer to supply as well as in-line analytical support to enable robust, world-wide availability of vaccines and biologics. This team is highly motivated, fast-paced and focused on the rapid advancement of Merck's vaccines and biologics pipeline and growth of the existing product lines. This position is within the BVA Outsourcing Oversight and Technical Core and will influence late stage development, validation, transfers and life-cycle management of methods supporting our organization's vaccines and biologics pipeline and inline products. Specific job responsibilities include analytical subcontract management, progress reporting, technical troubleshooting, project management, analytical development and optimization, and commercial life-cycle management of analytical strategy for vaccines and biologics.
• Management of comparability studies and analytical technology transfers
• Review of the systems and/or capabilities of analytical contract suppliers to assess alignment with compliance and need
• Review of protocols and reports from analytical contract suppliers
• Work with Procurement to manage and contract with critical reagent and critical supply vendors
• Draft critical reagent qualification strategies
• Regular communication, oversight and collaboration with external contract research organizations (CRO) for outsourced analytical methods, to monitor timelines and deliverables.
• Collaborate with contract labs on initiation, execution, and delivery of method development, validation and sample test results.
• Solve technical and nontechnical challenges throughout the life of the analytical project, communicating with departmental subject matter experts as needed
• Collaborate with Regulatory teams to support product registrations, launches, and troubleshooting activities, including documentation preparation, when the programs include outsourced components.
• Support analytical compliance and Quality for investigations and corrective actions.
• Draft analytical SOP updates.
• Ensure project results meet requirements regarding technical quality, reliability, schedule and cost.
• Project management and project forecasting.
• Initiate stakeholder feedback for CRO projects, update scorecards and complete after-action reviews.
• Support strategic initiatives within departmental and cross-functional teams representing Biologics, Vaccine Analytics (BVA).
• Travel, as required (up to 10%).
Education Minimum Requirement:
• Bachelor's degree in biology, chemistry, biochemistry or related sciences.
Required Experience and Skills**:
• Capability to manage individual components of a project and prioritize well.
• Proven organizational skills, good communication and problem solving ability
• Good technical, communication (oral and written), interpersonal, and teamwork skills.
• Experience working in a cGMP laboratory environment in the area of vaccines and/or biologics.
• Experience with or exposure to one or more of the following analytical techniques: Bioassay, Viral Infectivity assays (plaque/TCID50/others), Plaque assay, ELISA methods, PCR/RT-PCR, Sequencing, Separations methods (e.g. HPLC/UPLC), CE
Preferred Experience and Skills:
• Experience working with contract research organizations and/or procurement teams
• Ability to work independently and work within a cross-functional team
• Assay validation and transfer experience.
• Experience with continuous improvement or Project Management Professional certification.
• Self-motivated with a positive attitude and proven performance record.
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we're inventing for life.
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