Job Description
An amazing opportunity has arisen for a Process Development Engineer. A new position has opened in our growing Commercialisation, Development and Supply (CDS) team for a Specialist in Engineering focused on new small molecule API Commercialisation. This role offers exciting opportunities to work on multiple API projects, including manufacturing support, late-stage clinical development, scale-up, new product introductions, and technology transfers across our facilities.
Why you should apply!
Small Molecule (SM) Active Pharmaceutical Ingredient (API) manufacturing is evolving with the pipeline of the future, involving molecules of increasing complexity such as ADCs and macrocyclic peptides, as well as lower volume, higher potency products. We are investing in flexible facilities with small-scale trains for multi-product commercialisation, using both batch and continuous manufacturing technologies for late-phase clinical, launch, and early commercial supply.
What You Will Do
* Work as part of a multi-disciplinary team to meet project milestones and product launch timelines.
* Contribute to new product introductions and technical transfers, including new technologies.
* Collaborate with R&D to develop new SM API products.
* Provide expertise on API processing, scale-up, and operational issues to colleagues in Quality, Supply Chain, and Manufacturing.
* Evaluate raw materials, develop process fits, conduct safety and environmental reviews, review batch sheets, ensure regulatory and validation compliance, monitor processes, analyze cycle times, investigate deviations, and develop filing strategies.
* Develop batch documentation in accordance with cGMPs and EHS policies.
What Skills You Will Need
* A degree in Chemical Engineering or a related field, with at least 2 years of post-graduation experience in pharmaceutical manufacturing, or a PhD in Chemical Engineering or related discipline.
* Experience in API process development and/or supply is advantageous.
We are committed to ‘Inventing for Life’ and keeping patients at the center of our work. We value diversity and inclusion, believing that innovative solutions arise from diverse teams.
So, If You Are Ready To
Invent solutions for unmet healthcare needs, impact the future of healthcare, and inspire your team, please apply today.
Current Employees apply HERE
Current Contingent Workers apply HERE
Additional Information
Merck & Co., Inc. does not accept unsolicited assistance from search firms without a valid agreement. All CVs/resumes submitted without an agreement are the property of the company. No fee will be paid unless a pre-existing agreement is in place.
Employee Status: Regular
Relocation, Visa Sponsorship, Travel Requirements, and Flexible Work Arrangements: Hybrid
Shift, Valid Driving License, Hazardous Materials, and Job Posting End Date: 05/14/2025
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