Senior Principal Scientist, Downstream Biologics Process Development and Commercialization Job
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.
As part of the Merck Manufacturing Division, and operating within Global Vaccines and Biologics Commercialization (GVBC), the Biologics Process Development and Commercialization (BPDC) department provides manufacturing sciences expertise, through technical process leadership and laboratory capabilities, in the commercialization and post-launch support of Merck’s biologics pipeline. Working closely with colleagues across the biologics network, including Merck Research Labs (MRL), Operations, and Global Technical Operations (GTO), our department supports upstream cell culture, downstream purification, analytical testing and characterization, and technology transfer of biological processes (therapeutic proteins) from Phase III through commercial launch and transfer to the commercial supply network.
For the in-line support of commercial biologics, including, but not limited to, KEYTRUDA and ZINPLAVA, we provide deep scientific support for investigations, post-launch process enhancements, technology transfers, and the development and characterization of next generation processes post-approval. For pipeline biologics, we support various commercialization activities, including scale-up/scale-down, process characterization and validation, technology transfer and authoring of regulatory submissions.
Under the general scientific and administrative direction of the Director in Downstream Processing and working in conjunction with internal and external partners, this individual will support these late stage and commercial biologics program activities within BPDC. The individual will demonstrate a deep scientific understanding of the product and the process sciences, and will have broad, experience-based skillsets in both large scale manufacturing sciences and in applicable business processes required for the scope of BPDC activities, including influencing technical direction at Merck.
- Participates in and/or leads teams focusing on late stage clinical process development, characterization, and validation with line-of-sight for licensure and commercialization.
- Leads laboratory-scale and/or manufacturing scale studies to support commercial process validation, characterization, and investigation evaluations, including studies performed either in-house or externally. Provides technical leadership for the design of experiments, data analysis and interpretation, as well as the execution of (internal) or management of (external) laboratory activities.
- Provides technical leadership in the interpretations of trends observed in commercial process monitoring (e.g., statistical process control (SPC) and/or multivariate analyses (MVA)), and for further technical investigations and process changes that seek to drive improvements to yield and/or robustness
- Primary focus will be on downstream processing, but with a working knowledge of the various aspects of product manufacture and functional area interdependencies, including cell culture, analytical, and site readiness.
- Actively interacts with internal and external counterparts. Represents functional area on cross-functional and cross-divisional teams, and leads technical teams through matrix management structures.
- Authors required regulatory and technical documentation. Ensures that process/product are developed and documented according to standard Merck practices.
Culture and interactions with others
A Senior Principal Scientist is notably responsible for assuring that appropriate technical depth and scientific reasoning underpin the directions and decision making within all levels of the BPDC department and influencing technical areas at Merck
Able to work independently as well as lead multidisciplinary teams
Builds talent and group capabilities by influencing peers and mentoring junior staff members.
Shows flexibility and agility in responding to changing needs across BPDC and Merck.
Delivers what is needed on-time and holds self and team accountable for commitments, decisions, actions and behaviors.
- BS or MS in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry with 18 years relevant experience.
- PhD with 13+ year(s) of relevant experience.
- Technical expertise in purification of biological molecules from mammalian-based expression systems, including laboratory skills in chromatography and filtration systems (e.g., knowledge of scale down models).
- Experience with technology transfer and scale-up of processes to pilot and manufacturing scales for biologics manufacture.
- Excellent oral and written communication skills. Ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.
- Experience with downstream purification of biological molecules required, with an in-depth knowledge of preparative chromatography, tangential flow filtration, and virus retaining filtration desired. Demonstrated understanding of the fundamentals and/or modeling of unit operations is a plus.
- Technical operations experience in the manufacture of biological molecules at the pilot- and/or commercial-scale is a plus.
- Prior experience in drug substance process development, process characterization including viral clearance studies, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory BLA sections and/or working with external contract organization for development and or manufacturing.
- Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software)
- Working knowledge of statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for biologics processes
- Working understanding of analytical methods to characterize biologics and /or US/EU regulatory requirements and / or working knowledge of cGMPs is a plus
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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Job: Process Engineering
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck