Principle Scientist, Engineering

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.  The Vaccine Process Development and Commercialization (V-PDC) group within the Merck Manufacturing Division (MMD) focuses on late stage process development, technology transfer, and in-line support of vaccine products. We seek an energetic, people-oriented leader with strong scientific and technical skills to lead the development and commercialization activities supporting multiple vaccine programs. In this role, you will be responsible to: Oversee and lead technical teams in developing and executing vaccine and other bioprocesses related to pipeline commercialization, life cycle management of the existing vaccine portfolio, and deviation investigations.  Interface closely with process, formulation, analytical, manufacturing, quality, and regulatory groups to develop and execute on long-term strategies and product trajectories.  Be the primary point of contact in managing relationships with senior leadership, outsourced organizations, and health authorities. As a critical aspect of this role, you will teach, mentor, coach, and provide technical guidance. You will focus on expanding and evolving our culture of continuous learning and improvement through collaborations with manufacturing and research organizations. Direct management or mentorship of a small team of scientists Qualifications Education Minimum Requirement:  B.S. in Chemical Engineering, Biochemical Engineering Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 14 years of relevant experience Master's degree  in Chemical Engineering, Biochemical Engineering Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 12 years of relevant experience Ph.D. with 8 years of relevant experience. Required Skills: Extensive experience in large molecule process development, or relevant, experience including scaling (up and down) and tech transfer of large molecule drug substance processes. Recognized SME with deep technical knowledge and in-depth experience with vaccine process development & commercialization with ability to foster a collaborative work environment focused on mentorship, coaching, and Subject Matter Expert development. Extensive experience in various lab scale process models from high throughput to small scale, manufacturing representative models. Ability to drive programs and experiments in the context of long-term commercialization plan. Experience with Quality by Design (QbD), Design of Experiments (DOE), and Lean Six Sigma principles. Strong track record leading cross-functional, strategic initiatives Strong track record mentoring colleagues in direct and matrix organizations including minimum 2 years of direct people management and/or mentorship. Preferred Skills: Large molecule process development expertise with multiple vaccine or biologics platforms including: recombinant protein, live viral, polysaccharide, and conjugate Knowledgeable in Drug Substance, end-to-end process development.  Strong track record of effective collaboration across internal manufacturing and research divisions and with external academic and/or government research institutions. Recognized internationally as subject matter expert in large molecule drug substance (history of peer-reviewed publications and as invited speaker on these topics). Strong understanding of regulatory filing requirements (IND, MAA, BLA) with multiple agencies (FDA, EMA, JNDA, TGA). Prior experience with process transfer to internal and external manufacturing partners Advanced computer skills using statistical packages (JMP, MiniTab, etc)  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: PRO018582
Salary Range: NA
Minimum Qualification
8 - 10 years

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