Chemical Process Engineer
Kelly® Science & Clinical is seeking a Chemical Process Engineer for a contract position at a cutting-edge client in the pharmaceutical/API manufacturing industry in St Louis, MO.
About the role
Our client is an industry-leading company at the forefront of GMP Active Pharmaceutical Ingredient (API) manufacturing. They specialize in translating bench-scale chemistry into robust, commercial-ready processes — operating across kilo lab, pilot, and commercial scales to deliver high-quality small-molecule APIs that meet the most rigorous regulatory standards.
In this role, you will be responsible for bridging the gap between R&D and full-scale manufacturing. You will translate bench chemistry into plant-ready processes, optimize yield and quality, and support technology transfers across all scales of production. You'll collaborate cross-functionally with R&D, Analytical, QA/QC, Supply Chain, and external customers to ensure timelines and critical quality attributes are met — all within a cGMP-compliant environment.
Responsibilities
- Scale-up & Tech Transfer: Convert lab procedures into scalable unit operations including reaction, crystallization, filtration, and drying; author and execute transfer packages and PPQ protocols
- Validation & Compliance: Lead and author process validation documentation, batch records, and change controls; investigate deviations and out-of-specification (OOS) results and drive CAPA resolution
- Cross-Functional Collaboration: Partner closely with R&D/Analytical, QA/QC, Supply Chain, and external customers to meet project timelines and ensure Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) are achieved
- Documentation: Write SOPs, technical reports, and summaries suitable for regulatory inspections and internal governance
Requirements
- Education: BS in Chemistry, Chemical Engineering, or a related discipline
- Experience: 3–7 years of experience in GMP small-molecule API manufacturing and/or process scale-up
- Technical Skills: Demonstrated bench chemistry background with a strong understanding of reaction mechanisms, impurity control, and crystallization science — including chemical mass balance, reaction outcome prediction, and scenario-based problem solving
- Regulatory Knowledge: Solid grasp of cGMP standards, data integrity requirements, and regulatory expectations; strong technical writing ability
Benefits
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. Employees also 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. Additionally, employees are entitled to earn paid sick leave under the applicable state or local plan.
Pay
$45-55/hour
Schedule
Mon-Fri, full-time, on-site with occasional travel to customer sites expected.