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Senior Scientist - Biologics and Vaccine Formulation, Engineer

Merck is on a quest for cures and is committed to being the world's premier, most research-intensive biopharmaceutical company. Today, we're doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow and will take Merck's leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.    The Vaccine Drug Product Development in Merck Research Labs, West Point, PA is seeking a talented engineer to join our team in a Senior Scientist role.  The successful candidate will be expected to work as part of a team that is focused on the development of various innovative technology platforms and vaccine drug products.  The main responsibilities include the design and execution of experiments to support process development and Front-End Loading (FEL) activities for improvements associated with Innovative Drying technology platform and other capital projects that require complex problem analysis and solutions.   The successful candidate will be able to work in a fast-paced team environment and be able to lead technical and engineering development of Innovative Drying technologies to establish clinical capabilities within Merck's network while ensuring a Line of Sight to Commercial.  This position will work effectively and efficiently with our Engineering Services, Process Automation, Project Management, Process Safety, Manufacturing, and other stakeholders in the execution of projects. The candidate will assist with scale-up activities and engineering solutions to advance multiple projects. The candidate should possess technical knowledge and/or experience related to capital project charters, equipment and process development, performing Factory Acceptance and Site Acceptance Testing (FAT/SAT). The candidate will participate and support the capital project and process development teams focusing on benchmarking the technology, preparing basic engineering packages and contributing to safe, efficient and reliable designs of options to meet business initiatives. The candidate will participate as a discipline member on process hazard reviews and Risk assessment for capital projects and existing process flows. Experience with CMC aspects of biopharmaceuticals and working knowledge of formulation development, lyophilization or other drying technologies is a plus. Strong communication and collaborations skills as well as good documentation practices are essential. Qualifications   Education Minimum Requirement:        Ph.D. in Biomedical engineering, chemical engineering, Material Sciences or related discipline        M.S. (4 years + experience) in Biomedical engineering, chemical engineering, Material Sciences or related discipline        B.S. (6 years + experience) in Biomedical engineering, chemical engineering, Material Sciences or related discipline       Required Experience and Skills : o Drug Product development experience with biopharmaceuticals o Experience with process design and/or scale-up in the clinical or commercial space, including process flow diagrams & engineering drawings o Experience defining User Requirements and reviewing vendor designs to ensure compliance to specifications o Knowledgeable of the Capital Process having participated on a large capital project team o Exposure to project / engineering work process and deliverables o Ability to design, execute, and interpret experiments that will guide technology selection & develop Critical Process Parameters o Experience in equipment Fabrication, FAT/SAT, start-up, qualification and/or validation is preferred o Experience in the CMC aspects of biopharmaceutical development and the importance of the process changes to Regulatory filings o Working knowledge of lyophilization and/or other drying unit operations o Ability to drive innovation and think outside-the-box, but work within the constraints of the overall project timeline and budget o Experience with designing stability studies and interpreting results o Experience with preparation of safety assessment supplies and clinical supplies manufacturing o Excellent communication and collaboration skills o Strong attention to detail and ability to multi-task   Preferred Experience and Skills: o Independence in experimental planning & execution; pro-active in problem solving o Experience with sterile unit operations and knowledgeable of the Sterile Standards and equipment design standards o Understanding of the drug product manufacturing process and scale-up considerations o Experience with aseptic processing o Ability to interact on cross-functional teams and communicate with a wide range of scientists and engineers   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. Requisition ID: BIO005410
Salary Range: NA
Minimum Qualification
5 - 7 years

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