Process Development Engineer I - Manufacturing, Science And Technology (Msat)

Overview

We are seeking a motivated Engineer to join the Manufacturing Science and Technology (MSAT) team as a Product Development engineer. The individual will join a team in the clinical and commercial development of the processes used to manufacture a sustained release implant for use in the treatment of retinal diseases. The role includes but is not limited to experimental design, process development, product design, characterization, and GMP manufacture of clinical trial material. This individual will assist in execution of assigned project activities and work with project team members to improve, evaluate, and manufacture the drug product. The position is set in a dynamic and fast-paced environment.

Critical areas of focus will be in laboratory work and experimental design for technical transfers and scale up development. Incorporation of automation into a complex manual process will be another area of focus for this engineer.

Principal Duties and Responsibilities include the following:

• 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.

Qualification Requirements:

• 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 (Ex. 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