Chemical Engineer
About the role
The client in the pharma industry is hiring a Chemical Engineer (or Chemist) to lead technical transfers from a lab setting to a commercial setting. The ideal candidate should have experience with small molecule routes of synthesis and performing technical transfers from a lab to a commercial setting. Strong understanding of processes developed by synthetic chemists and the equipment needed at both scales is crucial.
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.
- Evaluate, design, and/or identify appropriate scalable equipment for lab, pilot, and commercial applications; partner with engineering to ensure fit-for-purpose systems.
- Lead/author process validation docs, batch records, change controls; investigate deviations/OOS and drive CAPA.
- Work closely with R&D/Analytical, QA/QC, Supply Chain, and external customers to meet timelines and CQA/CQPs.
- 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.
Additional Notes
We are looking for a Scientist- Chemical Engineer or Chemist that has experience with small molecule routes of synthesis and has performed technical transfers from a lab setting to a commercial setting. This includes understanding processes developed by the synthetic chemists and the equipment needed at both lab and commercial scale. Pharma experience is very important for this position.
Industry and Scale Experience
The ideal candidate should have experience in the pharmaceutical industry, with pilot-scale operations, bridging bench-scale and large manufacturing. 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. A Chemist or a Chemical Engineer may be a fit.
GMP Knowledge
GMP knowledge is helpful but not a firm requirement, as nuances can be quickly learned.
Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it’s the way we think job searching should be.
Client Information
The 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. They are a nonprofit/industry partnership focused on advancing domestic manufacturing of active pharmaceutical ingredients (APIs) through process innovation and technology, increasing U.S. competitiveness and supply-chain resilience that actively collaborates with universities and industry to lower production costs and support the reshoring of essential generic drugs.
Additional Notes
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan.
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