MSAT Process Engineer — Drug-Device Combo & Automation

Ocular Therapeutix, Inc.; Bedford (MA); On-site; USD 94,000 - 125,000; Full time

Job summary

Ocular Therapeutix, Inc. in Bedford, MA is seeking a mid-level engineer for the MSAT department to advance drug product and process development for hydrogel-based formulations.

You will design experiments, develop unit operations, support cGMP manufacturing, and help integrate drug product with a medical device, with a focus on automation, scale-up, and tech transfer. The role is full-time onsite in Bedford, MA, requiring a BS in engineering and 4+ years in biopharma; strong communication and

Qualifications

• Bachelor's degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering or related discipline.
• 4+ years of biopharma industry experience in drug or combination process development.
• Prior experience in a cGMP manufacturing environment.
• Ability to apply fundamental scientific and engineering skills to evaluation of processes.
• 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.
• Team-player who collaborates across functions.
• Experience with lab equipment (pipettes, balances, pumps, microscopes).
• Experience with automated or manual inspection systems.

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 clean rooms.
• Understand GMP regulation and FDA/EMEA guidance and apply them during manufacturing.
• Analyze and evaluate impact of process variables on product characteristics.
• Communicate study designs, data analysis and conclusions to project teams.
• Generate technical documents including protocols and reports summarizing results.
• Collaborate with MSAT group and project teams as an MSAT SME.
• Demonstrate understanding of late-stage development and tech transfer needs.

Skills

Written communication

Data analysis

Problem solving

Team collaboration

Initiative

Self-motivation

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering or related discipline

Tools

Lab equipment

Automated inspection systems

Job description

Ocular Therapeutix, Inc. in Bedford, MA is seeking a mid-level engineer for the MSAT department to advance drug product and process development for hydrogel-based formulations.

You will design experiments, develop unit operations, support cGMP manufacturing, and help integrate drug product with a medical device, with a focus on automation, scale-up, and tech transfer. The role is full-time onsite in Bedford, MA, requiring a BS in engineering and 4+ years in biopharma; strong communication and