Merck Executive Director, Chemical Engineering R&D in Rahway, New Jersey
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.
Responsible for the driving industry-leading innovations in chemical engineering that are implemented to enable world class commercial processes for new products at first filing, and occasionally for in-line products. The scope of this operation includes laboratory-based chemical engineering innovation, prep lab and pilot plant demonstration, and partnering with Process R&D and Merck Manufacturing Division colleagues to complete process characterization, technology transfer to commercial manufacturing sites and authoring of regulatory filing submissions.
Nature and Scope of Position:
Reports to the head of SM Process R&D, MRL. The role serves as a member on various cross functional strategic teams that include the Process Development Council, Regulatory Advisory Committee and R&D GMP Clinical Quality Council. The department head participates in network wide activities within Process R&D for setting strategic direction, prioritizing allocation of resources and managing budgets to align actions with strategy.
Supervises 3-5 Directors and through them, approximately 65 scientists, people managers, chemical engineers, process safety, pilot plant operations and equipment development staff, and technicians. Responsible for the appraisal and development of personnel under his/her supervision. Selects, trains, and effectively recommends transfers, merit increases, promotions, and closures of personnel under his/her direction within the framework of Company policy.
Accountable for chemical engineering research and development in MRL, and scale-up of various unit operations for manufacturing routes in prep lab, pilot plant and commercial sites. The organization, through the environmental and process safety engineering team, conducts process safety assessments for the entire small molecule pipeline, ensuring that all clinical and commercial processes are executed in accord with Merck’s safety standards.
Accountable for safe and compliant operations in the small molecule drug substance pilot plant facility, owning the automation control systems, delivering API for clinical supplies, providing process knowledge for all processes executed in the facility. Responsible for the proper coordination of laboratory programs with Pilot Plant or Factory demonstrations which result in the procurement of manufacturing data and the immediate preparation of experimental quantities of new products to supply material vital for laboratory research, pharmacological research and clinical and field investigations.
A successful incumbent will excel in collaborating with partner groups within Process R&D, Merck Manufacturing, and Regulatory CMC, to characterize new commercial manufacturing processes and demonstrate them at manufacturing sites in preparation for first commercial filing, and assist in the authoring of regulatory filing submissions for commercial products. Collaborates and influences both technically and strategically the capabilities of the API network inside the company and with key partners.
Directs the preparation of and approves disclosures prepared within his/her department to be used as the basis for patent applications.
Establishes, recommends, and maintains for MRL outside contracts, including grants, fellowships, and consultants in expressed fields of activity.
- B.S. or higher degree in Chemical Engineering or a related field.
10 years drug substance experience and demonstrated ability in leading a development group.
Demonstrated leadership in driving scientific excellence; translating breakthroughs in fundamental science to afford world class API manufacturing processes
Experience with driving technical and operational excellence in a pilot plant facility, including scale-up, operations, knowledge of regulatory and quality systems, capital planning, and technology transfer.
Must have excellent interpersonal, communication, and collaboration skills and strength in delivering results on firm deadlines.
Must be recognized in the pharmaceutical industry, through publications/presentations, for subject matter expertise.
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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Visa sponsorship is not available for this position.
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Job Chemical Engineering
Title: Executive Director, Chemical Engineering R&D
Primary Location: NA-US-NJ-Rahway
Requisition ID: CHE006275