Principal Scientist, Vaccines Process Development & Commercialization job in West Point
|Employer:|| Merck & Co.|
**Please note: this posting is being used to pipeline candidates for future openings |
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 development and in-line support of vaccine products. We seek an energetic, people-oriented leader with strong scientific and technical skills to lead the drug substance development and commercialization activities supporting multiple vaccine programs. Responsibilities also include scientific mentorship and technical development of bioprocess scientists and engineers. In this role you will be responsible for:
Oversee and lead technical teams in developing and executing microbial, cell culture and/or vaccine purification 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 of a small team of scientists.
B.S. in Chemical Engineering, Biochemical Engineering Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 14 years of relevant experience; or Master's degree with 12 years of relevant experience; or Ph.D. with 8 years of relevant experience.
Subject matter expertise in upstream process development including scaling (up and down) along with tech transfer of large molecule upstream (microbial fermentation and/or mammalian cell culture based processes), and/or downstream processes (lysis, normal and tangential-flow filtration, chromatography, continuous centrifugation, precipitation, and conjugation chemistry).
Recognized SME with deep technical knowledge and in-depth experience with upstream and/or downstream 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.
Expertise in upstream and/or downstream unit operation mathematical modeling, theoretical scaling calculations, computational fluid dynamics (CFD) modeling or similar approaches.
Ability to foster a collaborative work environment focused on mentorship, coaching, and Subject Matter Expert development.
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 mentoring colleagues in direct and matrix organizations including minimum 2 years of direct people management.
Large molecule upstream and/or downstream process development and optimization expertise with multiple vaccine or biologics programs and platforms including: recombinant protein, live viral, polysaccharide, and conjugates.
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 mammalian and microbial cell culture, virology and/or advanced cell biology (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).
Advanced computer skills using statistical packages (JMP, MiniTab, etc) and operation of other peripheral devices.
Subject matter expert in due diligence activities.
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