Process Development Engineer I - Manufacturing, Science and Technology (MSAT)

Role Summary

Process Development Engineer I - Manufacturing, Science and Technology (MSAT) at Ocular Therapeutix. Join the MSAT team to assist in the clinical and commercial development of processes used to manufacture a sustained release implant for retinal diseases, including experimental design, process development, product design, characterization, and GMP manufacture of clinical trial material.

Responsibilities

• Assist in the design and development, using sound engineering problem-solving techniques, of product and process development studies.
• Assist in the execution and characterization of product and process development studies.
• Assist in the development of scalable commercial manufacturing processes, meeting all critical quality attributes, using a QbD approach.
• Assist in the improvement of current clinical and commercial manufacturing activities.
• Assist in the implementation of automated systems.
• Assist in the cGMP manufacturing of drug product batches in clean room environment to support clinical studies.
• Develop understanding of GMP regulation and FDA/EMEA guidance on manufacturing process and apply them during manufacturing of drug product/device batches.
• Analyze and evaluate the impact of process and product variables on drug 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.
• Display a strong understanding of late-stage drug product development and transfer needs of commercial development.

Qualifications

• BS in Biomedical Engineering, Chemical Engineering, Mechanical Engineering or related discipline. Advanced degree (MS/PhD) desirable.
• 0-3 years of industry experience in drug product or process development or manufacturing.
• Strong understanding of engineering principles, methods and procedures.
• Demonstrated ability to apply strong fundamental scientific and engineering skills to evaluation of processes and development of practical solutions to technical challenges.
• Good interpersonal, communication, data analysis and effective 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 (e.g., pipettes, balances, pumps, microscopes) is preferred.
• Experience with tech transfer of development manufacturing processes to commercial scale is preferred.
• Experience with statistical software such as JMP, Minitab to report data is preferred.

Working Conditions

• Production Floor - gowning/cGMP requirements
• Laboratory/ECA - bending/lifting requirements