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Ocular Therapeutix

Process Engineer, MSAT

Bedford
$94k – $125k/yr
Posted 13 days ago
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Mid-Level Drug Product and Process Development Engineer – Manufacturing Sciences & Technology (MSAT)

Location: Bedford, MA (Onsite, Full-Time) Company: Ocular Therapeutix, Inc. (NASDAQ: OCUL)

Ocular Therapeutix, a biopharmaceutical company, develops innovative therapies for eye diseases using its proprietary ELUTYX™ hydrogel-based formulation technology. The company aims to reduce the burden of current eye care standards and establish itself as a leader in ophthalmology. Beyond medicine, Ocular Therapeutix fosters a collaborative, creative, and employee-focused culture.


About the Role

This mid-level engineer will work in the Manufacturing Sciences and Technology (MSAT) department, supporting the development, optimization, and scaling of processes for sustained-release hydrogel drug products. The role includes:

  • Participating in both clinical and commercial development, spanning experimental design, manufacturing, packaging, and material characterization.
  • Supporting process integration of a drug-product-medical-device combination product.
  • Operating within a dynamic, fast-paced environment at an expanding biotech company.

Key responsibilities revolve around process development, automation, and GMP compliance with emerging submission needs for Regulatory and Tech Transfer.


Principal Duties & Responsibilities

Key areas of focus include:

Drug Product & Process Development

  • Design, conduct, and characterize process development studies for hydrogel-based drugs.
  • Develop unit operations for a scalable commercial manufacturing process.
  • Improve existing clinical and commercial manufacturing activities.

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Automation & Process Integration

  • Implement automation for complex manual processes.
  • Collaborate on otechnical control and monitoring strategies for component integration.

cGMP Compliance & Manufacturing Support

  • Assist in cGMP manufacturing in cleanroom settings, supporting clinical drug product batches.
  • Ensure adherence to GMP regulations and FDA/EMEA guidance.
  • Evaluate implementation of process changes to optimize combination product characteristics.

Technical Documentation & Team Collaboration

  • Generate technical reports (protocols, SOPs, specifications) summarizing experimental plans and results.
  • Present data analysis and study designs to cross-functional teams.
  • Serve as an MSAT Subject Matter Expert (SME) in interactions with QA, Regulatory, and Operations teams.

Regulatory & Commercial Considerations

  • Gain experience in late-stage combination product development.
  • Contribute to tech transfer readiness for commercial deployment.

Requirements

  • Education:
    • Minimum bachelor’s degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, or a related scientific/technical field; master’s-level degrees preferred.
  • Experience:
    • 4+ years in biopharmaceutical process development (preferably drug or combination products).
    • Hands-on experience in cGMP manufacturing, ideally in cleanroom environments.
    • Proficiency in laboratory operations (pumps, balances, autoclaves, etc.).
  • Soft Skills & Competencies:
    • Strong scientific problem-solving and data analysis skills.
    • Clear communication (written and verbal) with regulatory implications.
    • Highly self-motivated and collaborative—thrives in cross-functional teams.
    • demonstrable written technical content creation (SOPs, test methods).
    • Adaptability to patient-focused, patient empowerment-inclusive industry-oriented challenges.
  • Preferred Experience:
    • Familiarity with manual/automated inspection systems for medical devices.
    • Experience linking device attributes to therapy outcome attributes in combo product design.

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Salary Range

$94,000–$125,000 USD (annually)


Working Conditions

  • Must meet gowning/clean room standards (production floor and laboratory access).
  • Bending and lifting requirements; mobility required to work within sterile environments.

Diversity & Equality Commitment

Ocular Therapeutix is an Equal Opportunity Employer; compliance with diversity, equity, inclusion (DEI) values, and federal/state/local anti-discrimination laws.

Privacy Policy: https://www.ocutx.com/privacy-policy/

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Skills

Process Development
Experimental Design
cGMP Manufacturing
Technical Transfer
Scale-up
Automation Integration
Data Analysis
Material Characterization
Combination Products
Technical Writing
Problem Solving
Laboratory Equipment

Location

Bedford, England, United Kingdom

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