Job Description
Position Title: Process Development Associate
Work Location: 10210 Genetic Center Drive, San Diego, CA 92121
Assignment Duration: 6 months
Work Schedule: First Shift, Monday through Friday, 6:30am to 3:00pm
Work Arrangement: 100% Onsite
Position Summary:
Primarily responsible for commercial manufacturing. Lesser role in the transfer of manufacturing processes from R&D to Manufacturing and continuous improvement of existing processes.
Background & Context:
Role supports commercial manufacturing operations in a pilot plant laboratory environment under regulated conditions for our organization.
Key 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.
Qualification & Experience:
• Bachelor’s degree (sciences)
• 1+ years’ experience preferred
• Basic knowledge of QMS (Quality Management System)/GMP requirements
• Must follow all applicable FDA regulations and ISO requirements
Working Conditions & Physical Demands (If Applicable):
• 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).
- For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 29.00/hr.