Process Development Associate

Job Description

Job Summary:

• Primarily responsible for commercial manufacturing.
• Also responsible for the transfer of manufacturing processes from R&D to Manufacturing and continuous improvement of existing processes.

Duties and Responsibilities:

• Maintains the Pilot Plant laboratory under cGMP conditions.
• Produces development, pilot, and production materials per written instructions.
• Completes ERP transactions.
• Stocks and maintains the laboratory supplies.
• Keeps accurate records and documentation.
• Completes laboratory work and associated paperwork by assigned completion dates.
• Produces notebook materials per written instructions.
• Develops manufacturing processes for transfer to Manufacturing.
• Assists with execution of process validation of new and existing manufacturing processes.
• Improves manufacturing processes.
• Completes cycle counts.
• Washes lab ware.

Education:

• Bachelor’s degree (sciences).

Experience:

• 1+ years’ experience preferred.

Skills:

• Basic knowledge of QMS (Quality Management System)/GMP requirements
• Must follow all applicable FDA regulations and ISO requirements.

Physical Demands:

• Sit; use hands to finger, handle or feel objects, tools, or controls.
• Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
• Lifting/moving and carrying products weighing up to 40 pounds.
• Exposure to moving mechanical parts, vibration and/or moderate noise levels.
• Exposure to hazardous chemicals or other materials.
• Safety Shoes with Impact and Compression Protection Must be worn (will be provided).
• Exposure to blood (serum).