Merck Senior Scientist, Engineering in Kenilworth, New Jersey
Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.
As part of the our Company Manufacturing Division, 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 our Company biologics pipeline. Working closely with colleagues across the biologics network, including our Research & Development Division, 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.
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 late stage pipeline and commercial biologics, providing deep scientific support for investigations, pre and post-launch process enhancements, technology transfers, and various other commercialization activities, including scale-up/scale-down, process characterization and validation, and authoring of regulatory submissions.
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
Provides technical leadership for the execution of (internal) or management of (external) laboratory activities.
Manages laboratory including all instrument maintenance, ordering, and analyst scheduling
Leads functional operation excellence 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.
Authors required regulatory and technical documentation according to standard our Company practices.
Shows flexibility and agility in responding to changing needs across BPDC and our Company.
Education Minimum Requirement:
- BS, MS, or PhD in Analytical Sciences, Biological Sciences, Chemical Engineering, Biological Engineering, or related field with 6 years (for BS), 4 years (for MS), or 0+ years (for PhD) relevant industry experience.
Required Experience and Skills:
Strong technical knowledge in the characterization of biological molecules.
Experience with HPLC and/or UPLC method development and execution.
Experience with team leadership in various stages of development and/or commercialization.
Preferred Experience and Skills:
Knowledgeable in biologics drug substance end-to-end process development
Experience providing scientific mentorship and guidance to technical coworkers and colleagues
Strong cross-functional background, enabling teams to reach peak performance
Ability to thrive in an ambiguous environment and collaborate across functions
Experience with analytical tech transfer
Working understanding of regulatory requirements and/or working knowledge of cGMPs
Strong communication skills with ability to foster a collaborative work environment focused on improving efficiency across BPDC
Experience authoring technical documentation to support regulatory submissions
Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software)
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.
Who we are …
Our Company, Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “Our Company” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth .
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Number of Openings:
Requisition ID: R9553
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