Upstream Manufacturing Associate I/III (CO)

SUMMARY:

The role of the Manufacturing Associate is to act as a controller, providing essential duties to support the respective production suite, Supervisor and Manager. On a daily basis, the Manufacturing Associate is expected to have a full understanding of the schedule and required tasks; promoting adequate assessment and response of any production demands.
 

PRINCIPAL RESPONSIBILITIES:

• Responsible for adherence to all Standard Operating Procedures (SOPs), Master Production Records (MPRs), protocols, policies, regulatory requirements, good manufacturing practices (GMPs), and safety guidelines.
• Participates in and/or leads unit operations described in standard operating procedures, manufacturing batch records, and cGMP guidelines.
• Proactively works with all team members, subject matter experts, and management to achieve training competency in production operations.
• Setup, maintenances, and use of cGMP equipment as directed by standard operating procedures and manufacturing batch records.
• Ensure compliance with company quality systems, safety procedures, and other company policies.
• Participate and support a culture of continuous improvement. Effectively collaborates with cross functional partners such as Quality Assurance, Quality Control, Supply Chain, and Facilities.
• Reviews executed batch production records to ensure compliance with approved procedures and GMP expectations.
• Operate analytical equipment, including analytical scale, pH meter, spectrophotometer, filter integrity tester, etc.
• Mix, store and dispose of chemical solutions (may include hazardous material).
• Works in a cleanroom environment, performing aseptic processing while maintaining manufacturing environmental conditions.

KNOWLEDGE, SKILLS & ABILITIES:

• Solid interpersonal and teamwork skills, able to work cross-functionally and collaborate with various levels.
• Ability to work in a cleanroom environment for extended periods of time.
• Flexible, have the availability to work hours necessary to support production and / or maintenance activities.
• Ability to lift up to 50 lbs. with assistance, push, pull, bend, and stand for prolonged periods of time.
• Willingness to learn and advance within the company and/or department.

EDUCATION/EXPERIENCE:

• High school diploma or equivalent required.
• Bachelor’s degree or Biotech certificate, quality systems regulations (cGMP) knowledge and clean room experience preferred but not required.
• Minimum 1 year of experience working within a federally regulated industry to be considered for a level greater than an Associate I.
• For consideration for a senior level, the associate must be proficient with the following systems, Vial Thaw & Passaging, Bioreactor Operations, Harvest Procedures, and BSC/LAF Aseptic Technique
• A pre-employment lift test and physical may be required for some positions within Manufacturing.
   

COMPENSATION RANGE:

Level I $23.31-$32.05

Level II $28.73-$39.50

Level III $36.04-$49.55

At AGC Biologics, we are always seeking dedicated and skilled Manufacturing Associates to join our team. By maintaining this evergreen job posting, we can connect with potential candidates as new opportunities arise within our team. We actively monitor applications and continuously match candidates to available positions, ensuring that we find the right fit for both you and our organization.