Associate 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, the Biologics Process Development and Commercialization (BPDC) department provides the technical process leadership and laboratory capabilities in support of late stage and commercial manufacturing processes for biologics (therapeutic proteins). The scope and activities include transfer of a Phase III or commercial processes to internal and external manufacturing sites, next generation process (i.e., post approval) development and characterization, process validation, regulatory submission authoring, and manufacturing investigation evaluations.
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 scientific, experimental and tech transfer skills focusing on downstream processing.
- Participates in teams focusing on late stage clinical process development, characterization, and validation with line-of-sight for licensure and commercialization.
- Responsible for laboratory-scale and 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 may lead 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
Shows flexibility and agility in responding to changing needs across BPDC and Merck.
Actively listens and participates in discussions and is appropriately assertive in expressing own ideas. Gives timely constructive feedback when appropriate.
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 10 years (for BS) or 8 years (for MS) relevant experience. PhD candidates with 4+ year(s) of relevant experience will also be considered.
- Technical expertise in purification of biological molecules from mammalian-based expression systems, including laboratory skills in chromatography and filtration systems.
- 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 late stage bulk 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