Federation of American Societies for Experimental Biology (FASEB)

Manufacturing Associate I/II

AGC Biologics
Longmont, Colorado, United States
11 days ago

Description

AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.

SUMMARY:

The Manufacturing Associate performs GMP manufacturing operations safely, reliably and in compliance with stated processes. 



Requirements

PRINCIPAL RESPONSIBILTIES:

  • Execute unit operations described in standard operating procedures and batch records
  • Perform bioprocess operations such as filtration, purification, cell culture or recovery
  • Perform review of GMP documentation
  • Clean, assemble/disassemble, sterilize and operate primary process equipment
  • Complete required processing documentation including deviation reports, change control, product change over, etc.
  • Ensure compliance with company quality systems, safety procedures, and other company policies.
  • Ensure acceptable quality and quantity of work executed.
  • Ensure that standard operating procedures are followed and are correct for bioprocess operations and equipment.
  • Other duties as assigned.

KNOWLEDGE, SKILLS & ABILITIES:

  • Expertise in relevant math, science and engineering disciplines.
  • Excellent aseptic technique
  • Thorough knowledge of GMP regulations (ICH Q7A) as it applies to job function
  • Thorough understanding equipment and technology as applies to job function.
  • Ability to exercise independent judgement when applying industry practices and company policies to daily operations.
  • Working knowledge of business practices used by company
  • Demonstrated ability to manage time efficiently and effectively.
  • Ability to interact constructively with peers and support groups
  • Organizational and communication skills necessary to ensure daily work plan is executed
  • Must be detail oriented, with the ability to complete written and verbally assigned tasks following specific procedures.
  • Ability to interact constructively with peers and support groups.
  • Excellent technical writing skills.

EDUCATION/EXPERIENCE:

  • BS in Chemistry, Biology or other relevant discipline
  • Depending on level, 1-8 years relevant experience, including experience in aseptic processing
  • Advanced computer skills including Excel and Word.
  • Equivalent education and experience may substitute for stated requirements

COMPENSATION RANGE:
$48,500- $68, 322 annually


AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any
other characteristic protected by applicable laws, regulations and ordinances

Job Information

  • Job ID: 54933280
  • Location:
    Longmont, Colorado, United States
  • Company Name: AGC Biologics
  • Position Title: Manufacturing Associate I/II
  • Job Function: Other
  • Job Type: Full-Time
  • Min Education: BA/BS/Undergraduate
  • Min Experience: 1-2 Years
  • Salary: $48,500.00 - $68,322.00 (Yearly Salary)
Biotechnology
Boulder , CO , US

AGC Biologics is a leading global Contract Development and Manufacturing Organization (CDMO), providing world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), viral vectors and genetically engineered cells. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast track projects for orphan drugs and rare diseases.   AGC Biologics purchased a state-of-the-art commercial m...

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