Responsibilities
- Facilitate transfer of chemical processes (with supervisory guidance) from development labs to pilot plant operations (kilohood or larger) to enable early-phase cGMP manufacturing of kilogram quantities of API for clinical trials.
- Receive and safety-evaluate incoming procedures; order and stage chemicals.
- Set up analytical methods; reprocess/analyze data for fact-based decisions; summarize results and challenges.
- Perform familiarization/use-test reactions and document lab trials to confirm plant readiness (reactions, distillations, extractions, crystallizations/isolations).
- Maintain detailed lab notebooks; prepare/replicate technical transfers.
- Author/review technical documents (tech transfer plan, SOPs, batch records, campaign summaries, deviation reports).
- Drive process improvement; support troubleshooting/investigations, RCA, and CAPAs.
Qualifications (Required)
- B.S. or M.S. in chemistry, chemical engineering, or related field.
- 2+ yearsβ 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 sponsorship).
Skills/Preferences
- Organic chemistry; scale-up experience; purification (extraction/crystallization/chromatography/distillation); larger glass equipment.
- Batch records/scale-up experiments; analytical techniques (HPLC/UPLC, LC-MS, GC, NMR, IR, KF, XRPD, etc.); mass balance.
- Communication, prioritization, attention to detail; root-cause problem solving; cross-functional collaboration.
Benefits/Compensation
- Anticipated wage: $66,000β$171,600; company bonus eligibility; 401(k), pension, vacation, medical/dental/vision, flexible benefits, life insurance, time off/leave, well-being benefits (e.g., EAP, fitness).
Other Information
- Locations: Indianapolis (initial) then Lebanon, IN (permanent). Travel <5%. Work in manufacturing and lab environments.