Responsibilities:
- Facilitate transfer of chemical processes from development labs to pilot plant operations (kilohood or larger) to enable early-phase cGMP manufacturing of kilogram quantities of API for clinical trials.
- Evaluate safety of incoming procedures with safety and process engineering; order and stage chemicals.
- Obtain reference materials; set up analytical methods; reprocess/analyze analytical data and present results.
- Perform familiarization reactions (reactions, distillations, extractions, crystallization/isolation) and run use-tests of key raw materials.
- Maintain detailed lab notebooks; author/review technical documents (tech transfer plan, SOPs, batch records, campaign summaries, deviation reports).
- Drive process improvements; support troubleshooting/investigations, root cause analysis (RCA), and CAPAs.
Qualifications:
- B.S. or M.S. in chemistry, chemical engineering, or related field.
- 2+ years manufacturing experience with synthetic small-molecule API/drug substance or fine chemical synthesis (preferred).
- Authorized to work in the U.S. full-time; no visa/work authorization sponsorship.
Preferred/Skills:
- Organic chemistry knowledge; synthetic chemistry and scale-up experience; purification (extraction, crystallization, chromatography, distillation).
- Experience with larger glass equipment; batch records/scale-up experiments.
- Analytical techniques (HPLC/UPLC, LC-MS, GC, NMR, IR, KF, XRPD); mass balance.
- Familiarity with crystallization/polymorphism/particle size control and safe handling of solids; strong communication and cross-functional collaboration.
Benefits (as stated): 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits (e.g., healthcare/dependent day care FSA), life insurance, time off/leave, well-being benefits.
Other role info: Initial Indianapolis location; permanent Lebanon, Indiana; limited travel <5%; manufacturing/lab environment required.