Process Engineer, MSAT
Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology, ELUTYX™. We strive to build a strong culture where employees can flourish and achieve their career goals through out-of-the-box thinking, cross-functional collaboration, and creativity.
About the Role
This position will serve as a mid-level engineer focused on drug product and process development in the Manufacturing Sciences and Technology (MSAT) department. The engineer will join a team in the clinical and commercial development of processes used to manufacture sustained release hydrogel drug products. Responsibilities include experimental design, process development, packaging, inspection, and material characterization. This role supports the integration of a drug product with a medical device to produce a combination product in a dynamic, fast-paced environment at a growing company.
Responsibilities
- Design, develop, execute, and characterize process development studies.
- Design and develop unit operations of a scalable commercial manufacturing process.
- Execute improvement of current clinical and commercial manufacturing activities.
- Implement and integrate automated systems into a complex manual process.
- Assist in the cGMP manufacturing of drug product batches in a clean room environment to support clinical studies.
- Understand GMP regulation and FDA/EMEA guidance on manufacturing processes and apply them during manufacturing of combination product batches.
- Analyze and evaluate the impact of process variables on combination product characteristics.
- Communicate study designs, data analysis, and conclusions to project team members.
- Generate technical documents including protocols and reports summarizing experimental plans and test results.
- Collaborate effectively with the MSAT group and project team members.
- Serve as an MSAT subject matter expert in cross-functional interactions with other departments.
- Demonstrate an understanding of late-stage combination product development and tech transfer needs of commercial development.
Requirements
- Minimum of a bachelor’s degree (advanced degree desirable) in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, or related discipline.
- 4+ years of biopharma industry experience in drug or combination process development.
- Prior experience working within a cGMP manufacturing environment.
- Ability to apply fundamental scientific and engineering skills to evaluate processes and develop practical solutions to technical challenges.
- Experience creating technical, written content.
- Demonstrated written and verbal communication skills.
- Demonstrated data analysis and problem-solving skills.
- High degree of initiative and self-motivation.
- A diligent team-player passionate about helping patients and collaborating in a dynamic, cross-functional environment.
Preferred Skills
- Experience with generic lab equipment (e.g., pipettes, balances, pumps, microscopes).
- Experience with automated or manual inspection systems.
Working Conditions
- Production Floor – gowning/cGMP requirements.
- Laboratory/Clean Room – bending/lifting requirements.
Pay
$94,000 USD - $125,000 USD