Associate Principal Scientist, Sterile Liquid Commercialization Engineering
West Point, PA, US
Requisition ID: PRO019381
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.
We currently have an exciting opportunity for an experienced product development Scientist/Engineer to join Sterile Liquid Commercialization (SLC) supporting sterile/liquid process development. The group is based out of West Point, PA.
SLC is responsible for product development, process scale-up, registration support, and launch support for Merck’s sterile drug products. 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. 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:
Lead product and process development studies for sterile/liquid products.
Represent SLC on cross-functional project teams and working groups.
Develop robust and scalable manufacturing processes while minimizing time to launch.
Implement process improvements to reduce cost structure and enhance robustness
Oversee preparation of materials for clinical trials and stability studies by collaborating with an internal and external network of pilot plants and manufacturing facilities.
Lead tech transfer of processes to commercial supply sites
Support execution of validation lots and contribute to regulatory filing documentation.
Be 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.
Lead 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 organization
Education Minimum Requirement:
Bachelor's degree in Pharmaceutics, Chemical Engineering or related-field with a minimum of 10 years of relevant experience; or Master's degree with a minimum of 8 years of relevant experience; or Ph.D with a minimum of 4 years of relevant experience
Required Experience and Skills:
Relevant experience commensurate with education level, as listed above
Preferred Experience and Skills: Relevant work experience, which may include any of the following:
Prior experience with the development and commercialization of large molecule products (biologics and vaccines), including scale-up, tech transfer, and process qualification. Specifically, experience with both vial & pre-filled syringe presentations and combination products
Demonstrated ability to lead new initiatives, drive change and improvements, introduction of new processes and integration in new facility integration
Leading cross-functional teams (e.g. product development)
Leading process characterization activities, including study design and oversight of junior scientists/engineers in the lab
Experience in authoring regulatory submissions and associated supporting source documents
Formulation and/or process development experience with complex molecules
Experience with process development and regulatory requirements for combination products
Knowledge 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 scale
Experience with new technology development and implementation
Experience with digitalization, collection & analysis of “big data”, modeling & programming
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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Visa sponsorship is not available for this position.
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