Mixed Modality (Peptide Downstream) Scientist - Process Translation and Execution

Responsibilities:

• Evaluate and facilitate transfer of peptide downstream manufacturing processes from development labs to pilot plant operations (kilo-scale and isolator environments) for early-phase cGMP API (grams–kilograms) clinical supply.
• Perform peptide purification/isolation; assess purification methods.
• Use peptide downstream procedures: reverse-phase chromatography, TFF, lyophilization, precipitation & drying.
• Evaluate safety of incoming procedures with safety and process engineering.
• Order/stage chemicals; obtain reference materials and set up analytical methods.
• Reprocess/analyze analytical data; summarize/present chemistry and challenges.
• Execute plant familiarization steps; perform use-tests and document Definitive Lab Trials to confirm plant readiness.
• Maintain detailed lab notebooks for technical packages and replication.
• Author/review tech transfer plan, SOPs, batch records, campaign summary and deviation reports.
• Apply process improvement; support troubleshooting, deviations/quality events/non-conformances; perform RCA and CAPAs.

Qualifications (Required):

• B.S./M.S. in chemistry, chemical engineering, or related.
• 3+ years peptide purification and/or manufacturing experience (synthetic peptide API/drug substance); reverse-phase chromatography preferred.
• Authorized to work in the U.S. full-time; no visa sponsorship.

Preferred:

• Peptide downstream knowledge; purification/purification scale-up experience; chromatography/TFF proficiency; downstream conjugation/cyclization.
• Comfort with preparative columns/TFF; attention to detail; batch record/scale-up experience.
• HPLC/UPLC, LC-MS, GC, NMR; mass balance.
• Cross-functional communication; QA/safety collaboration.

Location/Info:

• Initially Indianapolis/Carmel; permanent Lebanon, IN; travel <5%; manufacturing/lab environment.

Compensation/Benefits (as stated):

• Anticipated wage: $66,000–$171,600; possible company bonus; comprehensive benefits (401(k), pension, vacation, medical/dental/vision, flexible benefits, life insurance, time off/leave, well-being).