Manufacturing Associate Downstream (Flex)

Your Role

Join our dynamic team as a Manufacturing Associate, Downstream! In this role, you'll be a crucial part of our multi-product manufacturing facility, working in strict compliance with cGMP and Standard Operating Procedures. Your responsibilities will encompass various tasks, including production, meticulous documentation, report writing, materials procurement, and equipment scheduling. You'll be instrumental in ensuring the timely production and release of top-quality products.

• Ensuring the timely setup of equipment and materials for each production run.
• Planning and preparing all necessary resources for various processes and activities.
• Operating and diligently maintaining BioProcess chromatography skids.
• Proficiently handling the packing, unpacking, and cleaning of production-scale chromatography columns.
• Executing antibody and enzyme purification techniques using Affinity chromatography, Size Exclusion chromatography, Ion Exchange chromatography, Hydrophobic Interaction, and Tangential Flow Filtration (TFF).
• Conducting pH and conductivity meter calibration and testing.
• Managing product filtration processes, including sterile filtration, ultrafiltration, and viral filtration.
• Demonstrating exceptional aseptic techniques with precise, deliberate movements.
• Participating in product filling, including aseptic processing and media fill qualifications.
• Upholding the cleanliness and maintenance of cleanroom facilities and equipment.
• Monitoring and controlling raw material inventory levels.
• Ensuring compliance with Good Manufacturing Practices (GMP) documentation standards.
• Taking the initiative to revise and initiate Batch Production Records, Standard Operation Procedures, study protocols, and reports.
• Leading and managing independent projects as assigned, contributing to the overall success of the manufacturing team.
• Skillfully preparing media and buffer solutions critical for production processes.
• Performing thorough filter integrity testing using specialized equipment like the Sartocheck 3/4 Filter Integrity Tester.
• Operating and ensuring the proper maintenance of the ARS Frontier Autoclave.

Minimum Qualifications

• 2+ years of experience with large-scale liquid chromatography columns or similar equipment.
• 1+ years of related experience in the life sciences industry.
• Proficiency in working within a GMP production environment with aseptic techniques.
• Capability to gown for a class 10,000 cleanroom environment and work under aseptic conditions in a class 100 environment.

Preferred Qualifications

• Bachelor’s or associate degree (A.A.) with a preference for biology or chemistry emphasis.

Position Type/Expected Hours of Work

This role is a full-time onsite position with a Monday through Friday schedule, working 5 days and 8 hours each day (5 days x 8 hours), with operating hours from 5:00pm to 2:00am. During the initial training period, working days and hours will be Monday through Friday 7:00am to 4:00pm.