Process Engineer, MSAT

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. (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™. Ocular Therapeutix has built a robust product pipeline of drug delivery solutions developed to reduce the complexity and burden of the current standard of care and position itself to become a leader in the ophthalmic space.

Outside of the ophthalmic realm and behind the doors of our headquarters in Bedford, MA, we strive to build a strong culture where employees can flourish and achieve their career goals. We encourage out of the box thinking, cross-functional collaboration, and creativity.

Position Summary

This position will serve as a mid-level engineer focused on drug product and process development in the Manufacturing Sciences and Technology (MSAT) department. This engineer will join a team in the clinical and commercial development of the processes used to manufacture sustained release hydrogel drug products. This role includes but is not limited to experimental design, process development, packaging, inspection and material characterization. This individual will execute some assigned project activities, lead some project activities, and work with team members to improve, evaluate, and develop the products and their associated processes. This engineer will be supporting the integration of a drug product with a medical device to produce a combination product. The position is set in a dynamic and fast‑paced environment at a growing company.

Critical areas of focus will be in experimental design, laboratory work, testing, technical transfers, scale-up and new process development. Incorporation of automation into a complex manual process will be another area of focus for this engineer. This position will be based full-time onsite in Bedford, MA.

Principal Duties And 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 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 MSAT group and project team members.


• Serve as an MSAT SME 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 evaluation of processes and development of 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 that is passionate about helping patients and effectively collaborates in a dynamic, cross‑functional environment.


• Experience with generic lab equipment (Ex. pipettes, balances, pumps, microscopes) is preferred.


• Experience with automated or manual inspection systems is preferred.

Working Conditions

• Production Floor – gowning/cGMP requirements.


• Laboratory/Clean Room – bending/lifting requirements.

Salary Range: $94,000 USD - $125,000 USD

Ocular Therapeutix is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws regarding nondiscrimination. Ocular Therapeutix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or status as a veteran. For information on how Ocular Therapeutix collects, stores, and utilizes candidate information please see our privacy policy found at https://www.ocutx.com/privacy-policy/. For the Privacy Notice for California Job Applicants, please see CCPA Applicant Notice.