Project Engineer/Scientist - (US-PA-West Point - 19486)

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 Senior Project Scientist Therapeutic Protein Technologies this individual will support 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 technical skills.



Technical Scope:

Participates in late stage TP process development optimization and validation with line-of-sight for licensure and commercialization.
Operates effectively as a key member of multiple smaller teams and leverages experience to anticipate outcomes and make plans to enable success . Actively interacts with analytical form/fill regulatory and external counterparts.
Supports process characterization and process validation studies either in-house or externally. Designs 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.
Provides technical support for Mercks manufacturing processes. Responsibilities include supporting technology transfer process monitoring troubleshooting and continuous process improvements
Sets clear realistic and challenging goals and objectives.
Demonstrates the necessary collaboration skills to integrate input and perspective from various sources and demonstrates ability to explain the decision and its implications to key stakeholders.
Demonstrates willingness to apply appropriate tools in functional and team assignments..
Seeks feedback on performance during and after decision process.
Identifies and utilizes appropriate communication channels to most effectively make contact with key customers and keeps the customer informed on progress or other issues.

Desired:

Both downstream and upstream experience preferred but in-depth experience in one area acceptable. Prior experience in late stage bulk process development process validation authoring regulatory BLA sections and/or working with external contract organization for development and or manufacturing is a plus. Working understanding of analytical methods to characterize biologics and /or US/EU regulatory requirements and / or working knowledge of cGMPs is a plus

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