Associate Principal Scientist
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 is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of biologics, vaccines, 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 onin-process characterization, but with a strong working knowledge of thevarious aspects of product manufacture and functional area interdependencies,including cell culture, purification, and site readiness.
- Represents functional area oncross-functional and cross-divisional teams.
- Leads strategic initiatives withinBPDC and the wider division.
- Leads process and product comparabilityassessments to support facility and process changes during late stagedevelopment or in-line product support.
- Leads matrix teams responsible forin-process characterization testing of laboratory-scale andmanufacturing-scale studies to support commercial process validation,characterization, and investigation evaluations, including studies performedeither in-house or externally.
- Provides technical leadership formethod development and qualification, as well as the execution of (internal)or management of (external) laboratory activities.
- Authors required regulatory andtechnical documentation according to standard Merck practices.
- Shows flexibility and agility inresponding to changing needs across BPDC and Merck.
Education Minimum Requirement:
BS in Analytical Sciences, Biological Sciences, Chemical Engineering, Biological Engineering with a minimum 10 years
MS in Analytical Sciences, Biological Sciences, Chemical Engineering, Biological Engineering with a minimum 8 years relevant industry experience.
PhD candidates with a minimum 4 years post PhD graduate of relevant industry experience will also be considered.
Required Experience and Skills:
- Demonstrated experience leading technical teams, strategic initiatives and/or managing direct reports
- Ability to communicate cross functionally and lead with influence
- Demonstrated experience managing projects
Preferred Experience and Skills:
- 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.
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: 1
Shift (if applicable):
Hazardous Materials: no
Company Trade Name: Merck