Job Description
Compass Bio Labs is a US-based contract manufacturer of lyophilized peptide products for the licensed healthcare practitioner market, producing sterile vialed SKUs in an ISO-7 aseptic environment for established brand partners. We are founder-led, well-capitalized, and scaling fast. Our trajectory is on a monumental curve, and we are hiring to invest not to fill seats. We are looking for a senior operator to own our production system end to end: formulation, fill-finish manufacturing, and the bridge between the two. You'll report directly to the founder and the leadership team. No layers, no committees. You will be the senior production decision-maker your work shows up in the COA on every vial that ships. We respond to every applicant within 48 hours. What you'll own Formulation Lyophilization cycles for existing SKUs and any new peptide added to the catalog. Tune cycle parameters for consistent cake formation, low residual moisture, and stable shelf life. Excipient selection, fill volumes, and bulking agent ratios per peptide. Formulation troubleshooting when a batch goes out of spec. A documented, versioned formulation library one stable recipe per SKU. Manufacturing operations Aseptic fill-finish end to end: compounding, sterile filtration, aseptic fill, lyophilization, stoppering, capping, visual inspection, labeling. Batch records and SOPs write them, train operators on them, sign off on completed lots. Yield. Drive measured improvement. The lyophilizers with stoppering: cycle development, validation, preventive maintenance, calibration. Third-party QC release testing per lot (HPLC, MS, LAL, sterility, Karl Fischer). New SKU bring-up Take a new peptide from concept to a documented, repeatable process producing a stable, COA-released product. Who you are Required Demonstrated track record in pharmaceutical manufacturing, with significant experience in lyophilization and aseptic fill-finish operations. Proven formulation development for parenteral or injectable products. Peptide experience strongly preferred; protein or biologic experience acceptable. Comfort writing batch records, SOPs, deviation reports, and CAPA documentation. BS or MS in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or Biochemistry. PhD welcome. Strongly preferred Direct peptide manufacturing experience (synthetic peptides, GLP-1 analogs, regenerative peptides). Experience qualifying API suppliers and managing supplier corrective actions. Familiarity with USP <71>, USP <85>, USP <797>/<800>, and ISO 14644 cleanroom standards. Track record of yield improvement projects with measurable financial impact. Experience architecting production systems rather than inheriting mature ones. Pay: $140,000.00 - $180,000.00 per year Benefits Dental insurance Health insurance Relocation assistance Vision insurance Work Location: In person