Requisition ID: PRO018408
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.
This position is for a Senior Scientist / Engineer in Pharmaceutical Commercialization Technology (PCT). This group is responsible for pharmaceutical process development of oral solid, oral liquid, and topical drug products from Phase IIb through regulatory filings, process validation, and into the first few years of commercial launch. The group's work is facilitated by a network of commercialization sites which are currently located in Ireland and Puerto Rico, coupled with a pilot plant in West Point, PA and a worldwide network of 3rd party sites to form the foundation of development and commercialization capabilities.
This role works under general supervision to plan, conduct, evaluate, and interpret pharmaceutical process development studies, including scale up, design space development, clinical and formal stability batch manufacture, and Process Performance Qualification/Validation. The Senior Scientist/Engineer may lead Drug Product or Technology Development teams, and represent the department in significant cross-functional interactions. Problem-solving skills are essential and knowledge of concepts of Quality by Design, including risk-based approaches to development, design of experiments, and process modeling, are desired. Proficiency in technical writing and documentation practices is required to prepare experimental protocols and reports in support of product registration efforts. Strong oral communication skills are needed to effectively collaborate within teams. Strong collaboration and team leadership skills are also desired.
Other responsibilities include physical testing, data analysis, technology evaluation, compliance with applicable safety and current good manufacturing practices, external publications (as appropriate), and patent applications.
Educational expectations include PhD in Chemical Engineering, Materials Science/Engineering, Pharmaceutical Sciences, or a related discipline by December, 2018. Prior industry experience is not required.
Education Minimum Requirement:
- Educational expectation is a PhD in Chemical Engineering, Materials Science/Engineering, Pharmaceutical Sciences, or a related discipline by December, 2018.
- Preferred Experience and Skills:
- Recent PhD graduate; industry experience not required
- The ideal candidate would have experience with or understanding of one or more of the following:
- Experience with process scale-up and/or technology transfer, moving from laboratory to pilot or production scale
- Demonstrated capability to develop and execute an experimental program to address issues of process robustness, productivity, and/or cost, integrating efforts with specialists in other technical disciplines
- Experience with chemical engineering-related technology development
- Familiarity with concepts and application of cGMP during pharmaceutical development and production
- "Big data" tools for analyzing process performance
- Development, application or validation of process models
- Development or application of statistical process control techniques
- Understanding of process dynamics
- Knowledge and use of statistical techniques as applied to product sampling
Graduation dates of December 2018 or earlier preferred.
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: Process Engineering
Other Locations: West Point, PA, US
Employee Status: Regular
Travel: Yes, 15 % of the Time
Number of Openings: 1
Shift (if applicable):
Hazardous Materials: pharmaceutical actives and solvents
Company Trade Name: Merck
Nearest Major Market: New York City
Nearest Secondary Market: Newark