Associate Principal Scientist, Process Analytics - Biologics Process Development and
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 Kenilworth lead of BPDC Process Analytics, and working in conjunction with internal and external partners, this individual will support in-process analytical and characterization testing of late stage drug substance process development and characterization, technology transfer, post-approval process development and validation studies for Merck’s commercial biologics products as well as pipeline programs. The individual will demonstrate strong scientific, experimental and technology transfer leadership and skills focused on common analytical methods used for biologics.
- Primary focus will be on in-process analytics, but with a working knowledge of the various aspects of product manufacture and functional area interdependencies, including cell culture, purification, and site readiness.
- Represents functional area on cross-functional and cross-divisional teams.
- Leads process and product comparability assessments to support facility and process changes during late stage development or in-line product support.
- Leads matrix teams responsible for in-process characterization testing of 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 method development and qualification, as well as the execution of (internal) or management of (external) laboratory activities.
- Authors required regulatory and technical documentation according to standard Merck practices.
- Shows flexibility and agility in responding to changing needs across BPDC and Merck.
- Bachelors Degree or higher in Analytical Sciences, Biological Sciences, Chemical Engineering, Biological Engineering, or related field with a minimum of ten (10) years (for BS), a minimum of eight (8) years (for MS), or a minimum of four (4) years (for PhD) of relevant industry experience.
- In-depth technical knowledge and expertise in the characterization of biological molecules.
- Experience with HPLC and/or UPLC method development and qualification.
- Experience with people management and/or team leadership in late-stage development or commercialization teams.
- Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software), statistical process control (SPC), multivariate analysis (MVA), and/or process analytical technologies (PAT) techniques for biologics processes
- Working understanding of US/EU regulatory requirements (e.g. comparability, method transfer).
- Working knowledge of cGMPs.
- Working knowledge of mass spectrometry.
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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