Process Engineer, MSAT
Ocular Therapeutix, Inc.
August 22, 2026
On-site
Bedford, MA
Operations
Position Summary
- Mid-level engineer focused on drug product and process development in the MSAT department for sustained release hydrogel drug products.
- Supports clinical and commercial process development, including experimental design, process development, packaging, inspection, and material characterization.
- Assists in integrating a drug product with a medical device to produce a combination product.
Principal Duties And Responsibilities
- Design, develop, execute, and characterize process development studies.
- Design and develop unit operations for a scalable commercial manufacturing process.
- Improve current clinical and commercial manufacturing activities.
- Implement and integrate automated systems into a complex manual process.
- Assist in cGMP manufacturing of drug product batches in a clean room environment for clinical studies.
- Apply GMP and FDA/EMEA guidance to manufacturing combination product batches.
- Analyze impact of process variables on combination product characteristics.
- Communicate study designs, data analysis, and conclusions.
- Generate technical documents (protocols and reports).
- Collaborate with MSAT and project teams; serve as an MSAT SME.
- Understand late-stage combination product development and tech transfer needs.
Requirements
- BS minimum (advanced degree desirable) in Chemical, Biomedical, Mechanical Engineering or related field.
- 4+ years biopharma experience in drug/combination process development.
- Prior cGMP manufacturing experience.
Preferred Skills/Experience
- Experience with generic lab equipment (pipettes, balances, pumps, microscopes).
- Experience with automated or manual inspection systems.
Skills
- Technical problem-solving; apply scientific/engineering skills to practical solutions.
- Technical writing; strong written/verbal communication; data analysis.
- Initiative, self-motivation, and cross-functional teamwork.
Salary Range (if included): $94,000–$125,000.
Working Conditions
- Production floor: gowning/cGMP requirements.
- Lab/clean room: bending/lifting requirements.
- Mid-level engineer focused on drug product and process development in the MSAT department for sustained release hydrogel drug products.
- Supports clinical and commercial process development, including experimental design, process development, packaging, inspection, and material characterization.
- Assists in integrating a drug product with a medical device to produce a combination product.
Principal Duties And Responsibilities
- Design, develop, execute, and characterize process development studies.
- Design and develop unit operations for a scalable commercial manufacturing process.
- Improve current clinical and commercial manufacturing activities.
- Implement and integrate automated systems into a complex manual process.
- Assist in cGMP manufacturing of drug product batches in a clean room environment for clinical studies.
- Apply GMP and FDA/EMEA guidance to manufacturing combination product batches.
- Analyze impact of process variables on combination product characteristics.
- Communicate study designs, data analysis, and conclusions.
- Generate technical documents (protocols and reports).
- Collaborate with MSAT and project teams; serve as an MSAT SME.
- Understand late-stage combination product development and tech transfer needs.
Requirements
- BS minimum (advanced degree desirable) in Chemical, Biomedical, Mechanical Engineering or related field.
- 4+ years biopharma experience in drug/combination process development.
- Prior cGMP manufacturing experience.
Preferred Skills/Experience
- Experience with generic lab equipment (pipettes, balances, pumps, microscopes).
- Experience with automated or manual inspection systems.
Skills
- Technical problem-solving; apply scientific/engineering skills to practical solutions.
- Technical writing; strong written/verbal communication; data analysis.
- Initiative, self-motivation, and cross-functional teamwork.
Salary Range (if included): $94,000–$125,000.
Working Conditions
- Production floor: gowning/cGMP requirements.
- Lab/clean room: bending/lifting requirements.