Prinicipal Engineer/Scientist - (US-NJ-Rahway - 07065)

Minimum Education: Tech School
Job Type: Full Time
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Merck & Co. Inc. established in 1891 is a global research-driven pharmaceutical company dedicated to putting patients first.



Join us and experience our culture first-hand - one of strong ethics & integrity diversified experiences and a resounding passion for improving human health. As part of our global team youll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

Under general scientific and administrative direction from the Director/ Associate Director Therapeutic Protein Technologies this individual will be responsible for late stage bulk process development technology transfer and validation studies associated with the development of new products bulk processes systems and bulk facilities related to therapeutic proteins (TPs). The individual will demonstrate advanced skills that optimize business and technical processes. The person in this position participates in high impact complex cross-functional teams and initiatives and will prepare comprehensive reports and communications on projects. The individual may be responsible for supervising a small group or managing a budget as necessary. The candidate will support implementation of cultural changes to realize the One Merck vision.



Technical and Business Scope:

Provides technical leadership to TP late stage process development optimization and validation with line-of-sight for licensure and commercialization. Collaborates seamlessly with all key partners to enable successful commercialization.
Provides seamless integration with Merck research CROs and CMO and manufacturing sites as needed to enable product development and technology transfer throughout product life cycle. Actively interacts with analytical form/fill and regulatory counterparts. Represents functional area on cross-functional and cross-divisional teams. Explains implications to key stakeholders and displays ownership in supporting informed cost/benefit decisions based on analysis of inputs outcomes risk and likely return.
Is responsible for process characterization and process validation studies either in-house or externally. Manages and conducts hands-on experimental studies in support of process characterization. Has a focus on process robustness and cost-effectiveness.
Authors required regulatory and technical documents. Ensures that process/product are developed and documented per standard Merck practices.

Education Requirement:

BS/MS in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry with at least 10 years relevant experience or Ph.D in Biological Sciences/Chemical
Engineering/Biological Engineering/Chemistry with at least 4 years relevant experience preferred. (May be combination of post-graduate education and/or work-related experience.)

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