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Senior Scientist Sterile Liquid Commercialization

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West Point, PA

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Requisition ID: PRO017781Merck & 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 itsu00a0legacy for over a century. Mercku2019s 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 thatu2019s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.u00a0We currently have an exciting opportunity for an experienced product development Scientist/Engineer to join Sterile Liquid Commercialization (SLC) supporting sterile/liquid process development.u00a0 The group is based out of West Point, PA.SLC is responsible for product development, process scale-up, registration support, and launch support for our organizationu2019s sterile drug products.u00a0 SLC develops formulation and filling processes for sterile pharmaceuticals, vaccines, and biologics programs starting at Phase II and extending through initial years of product launch.u00a0 SLC also supports life cycle management opportunities and significant process improvements for in-line sterile products.The person in this role will have the opportunity to:u00a0Lead product and process development studies for sterile/liquid products.u00a0Represent SLC on cross-functional project teams and working groups.u00a0Develop robust and scalable manufacturing processes while minimizing time to launch.u00a0Implement process improvements to reduce cost structure and enhance robustnessOversee preparation of materials for clinical trials and stability studies by collaborating with an internal and external network of pilot plants and manufacturing facilities.u00a0Lead tech transfer of processes to commercial supply sitesu00a0Support execution of validation lots and contribute to regulatory filing documentation.u00a0Be recognized as a technical expert and scientific contributor.Coach other employees on scientific/technical concepts and assist staff members with the design and execution of lab experiments.u00a0u00a0Lead in creating, sharing, and adopting best practices and business process strategies.Travel to global and domestic research and manufacturing sites as required.Learn new skills while developing your career in a highly diverse and dynamic organizationQualificationsEducation Minimum Requirement:u00a0Bachelor's degree in Pharmaceutics, Chemical Engineering or related-field with a minimum of 6 years of relevant experience; or Master's degree with a minimum of 4 years of relevant experience; or Ph.D. with less than 1 year of relevant experienceRequired Experience and Skills**:u00a0Relevant experience commensurate with education level, as listed abovePreferred Experience and Skills:Prior experience with the development and commercialization of large molecule products (biologics and vaccines), including scale-up, tech transfer, and process qualification.u00a0 Specifically, experience with both vial & pre-filled syringe presentations and combination productsParticipating in and/or leading cross-functional teams (e.g. product development)Experience in the design and execution of process characterization activities, including oversight of laboratory personnelKnowledge of cGMP and typical unit operations for the manufacture of sterile dosage forms.Operations experience in the manufacturing of sterile drug products, at pilot and/or commercial scaleFormulation and/or process development experience with complex moleculesExperience in authoring regulatory submissions and associated supporting source documentsExperience with process development and regulatory requirements for combination productsExperience with processing mointoring & analytics, digitalization, collection & analysis of u201cbig datau201d, modeling & programmingExperience with new technology development and implementationYour role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and weu2019re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, weu2019re inventing for life.u00a0u00a0If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request ****. u00a0u00a0Search Firm Representatives Please Read Carefully:u00a0Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.u00a0 Please, no phone calls or emails.u00a0 All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.u00a0 No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.u00a0Visa sponsorship is not available for this position.u00a0For more information about personal rights under Equal Employment Opportunity, visit:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0EEOC Posteru00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0EEOC GINA Supplementu00a0Job: Process EngineeringOther Locations: Employee Status: RegularTravel: Yes, 10 % of the TimeNumber of Openings: 1Shift (if applicable): N/AHazardous Materials: NoCompany Trade Name: Merck,employmentType:[,OTHER],title:Senior Scientist, Sterile Liquid Commercialization,url:****Point,addressRegion:Pennsylvania,addressCountry:United States,postalCode:19486}},hiringOrganization:{@type:Organization,name:Merck,logo:****{@context:****Scientist, Sterile Liquid Commercialization}}]}

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