Description
Chemical Engineer (St. Louis, Missouri)
We are looking for an experienced Chemical Engineer that can help our client set up small molecule pharmaceutical processes, including spec'ing equipment, interlinking equipment, identifying control systems- all in all- leading chemical technology transfer to a contract manufacturing site.
More about the Role: Lead API Scale-Up in a Cutting-Edge GMP Facility! 3-7 years' experience in GMP API manufacturing needed, you'll translate bench chemistry into robust, plant-ready processes, optimize yield/quality, and support tech transfers across kilo lab, pilot, and commercial scales. Experience with continuous manufacturing platforms and designing/identifying scalable equipment will be key as we expand capabilities. Occasional travel to customer sites may be expected. Key Responsibilities: Scale-up & Tech Transfer: Convert lab procedures to scalable unit operations (reaction, crystallization, filtration, drying), author/execute transfer packages and PPQ protocols. Continuous Manufacturing: Develop, implement, and optimize continuous processes for small-molecule APIs, ensuring robustness and regulatory compliance. Equipment Design & Scale: Evaluate, design, and/or identify appropriate scalable equipment for lab, pilot, and commercial applications; partner with engineering to ensure fit-for-purpose systems. Validation & Compliance: Lead/author process validation docs, batch records, change controls; investigate deviations/OOS and drive CAPA. Cross-Functional Collaboration: Work closely with R&D/Analytical, QA/QC, Supply Chain, and external customers to meet timelines and CQA/CQPs. Documentation: Write SOPs, reports, and technical summaries suitable for regulatory inspections. Qualifications: BS in Chemistry, Chemical Engineering or related discipline. 3-7 years in GMP small-molecule API manufacturing/scale-up. Bench chemistry background with strong understanding of reaction mechanisms, impurity control, and crystallization science. Solid grasp of cGMP, data integrity, and regulatory expectations; strong technical writing Hands-on experience with continuous manufacturing approaches and equipment design/selection for scale-up strongly preferred. Role is a Contract to Hire. Still need medical? We got you covered! Additional Notes: We are looking for experienced Chem E's that can help set up small molecule pharmaceutical processes including spec'ing equipment, interlinking equipment, help in identifying control systems, and helping with technology transfer to a contract manufacturing site.
Need for Chemical Engineering: Support tech transfer for three molecules, as their current chemists lack expertise in mechanical engineering aspects like specking out equipment.
Employment Structure: The role is intended to start as a Contractor with the intent to mature into a full-time, permanent role after trial period, usually under six months.
The Chemical Engineer will focus on the development part of tech transfer, ensuring processes and equipment are correct for scaling up from bench to pilot scale, rather than just mechanical aspects.
Industry and Scale Experience: The ideal candidate should have experience in the pharmaceutical industry (chemistry, not biologics) and with pilot-scale operations, bridging bench-scale and large manufacturing.
GMP Knowledge: GMP knowledge is helpful but not a firm requirement, as nuances can be quickly learned.
Ideal Candidate Path: The ideal candidate would have started at the bench and worked their way up into an engineering role, demonstrating cross-functional experience. Client is a non-profit entity in St. Louis, Missouri dedicated to delivering market-competitive commercial supply of U.S.-made active pharmaceutical ingredients (API) to strengthen the domestic pharmaceutical supply chain. Their focus is on de-risking the commercialization and adoption of advanced manufacturing technologies, such as continuous flow chemistry, to successfully re-shore domestic production of API.
They are at the forefront of reshoring pharmaceutical ingredient manufacturing to the U.S., projecting up to $1.2 billion in regional economic growth and driving innovation through collaborations with companies, research institutions, and public agencies—a major reason to join their mission-focused team!
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