Upstream Manufacturing Associate – at AGC Biologics, Apply Now!
AGC Biologics, a global leader in biopharmaceutical manufacturing, is seeking motivated candidates for the role of Upstream Manufacturing Associate I/III in Colorado. This role supports critical production activities within a cleanroom setting, ensuring compliance with GMP standards while contributing to the safe and efficient manufacturing of life-saving biologics. If you’re looking to advance in the biotech industry, AGC Biologics offers a strong foundation with training, growth opportunities, and competitive compensation.
About AGC Biologics:
AGC Biologics is a leading global contract development and manufacturing organization providing extensive services in the biopharmaceutical industry. Committed to delivering high-quality services, AGC Biologics focuses on helping clients accelerate the development of life-saving therapeutics.
Job Title: Upstream Manufacturing Associate I/III (CO)
Job Requisition ID: JR100951
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 to 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 as Associate.
- 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 as Associate.
- 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 as Associate.
- 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 cleanroom 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 specific systems and techniques.
- 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
Keywords: Manufacturing Associate job opportunity, Upstream Manufacturing role, Biopharmaceutical industry, AGC Biologics, GMP guidelines, cleanroom environment.
