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. 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:

We are currently looking for a Quality Control Scientist I, Microbiology (Shift Lead Supervisor) to join the AGC Biologics team.  This position will provide technical and compliance leadership related to microbiological assays, environmental monitoring, facility qualification, and GMP quality systems within the Quality Control department. The individual in this role will also review data, author reports, and support laboratory instrument validation as required. The ideal candidate will have extensive experience in biopharmaceutical microbiology, GMP compliance, environmental and utility monitoring, and strong organizational skills. This position will oversee QC analysts as a team lead or supervisor. Experience in a GMP Microbiology laboratory is preferred. This may be a Sunday through Wednesday or a Wednesday through Saturday (4- 10 hour) Day Shift, position. 
 

KEY RESPONSIBILIES:

  • Complete microbiology and environmental monitoring assays, including bioburden, endotoxin, conductivity and total organic carbon (TOC). 
  • Perform and oversee product and facility testing related to microbiological assays, review data and interpret and report results. 
  • May perform sampling of water for injection, air, clean steam, compressed gas and facility surfaces/air in ISO classified manufacturing spaces. 
  • Support projects / initiatives / team goals by delivering on all assigned tasks. 
  • Perform data verification and data entry. 
  • Seeks opportunities for continual learning and improvement. 
  • Participate in test method transfers and assay validations. 
  • Act as subject matter expert on microbiological assays, method qualification, technical troubleshooting, and instrument validation.           
  • Support onboarding and qualification of laboratory equipment and GMP software systems. 
  • Assist with the generation of SOPs related to test methods and product release. 
  • Assist in drafting technical documents including test methods, validation documents, and deviations. 
  • Implement change controls, lead investigations, and complete CAPAs in support of GMP operations. 
  • This position will support preparation of quarterly and annual reports, trend investigations, statements of quality, and other applicable reports. 
  • Serve as a trainer for Junior Analysts 
  • Serve as a Subject Matter Expert on a particular method, program or discipline 
  • Represent QC Microbiology on cross-functional teams and prepare and present data to internal and external clients.      
  • This position will support and provide oversight of laboratory analysts and laboratory analyses, testing logistics, data review, and mentoring and coaching of lab analysts. 

KNOWLEDGE, SKILLS & ABILITIES:

  • Requires knowledge of environmental and utility monitoring programs, compendial microbiological testing (Bioburden, Endotoxin) and testing of water for injection. 
  • Experience working in a GMP laboratory. 
  • Strong organizational skills in a high-throughput environment. 
  • Excellent communication with clear and concise writing & verbal presentation skills. 
  • Ability to interact well in a team environment 
  • Demonstrated organizational skills and attention to detail. 
  • Ability to lift 50 lbs. 

EDUCATION/EXPERIENCE:

  • Education: Minimum BS in Biology, Microbiology, or other scientific discipline. 
  • Minimum of 5+ years hands-on experience in a GMP QC Laboratory 
  • Prior supervisory experience strongly preferred
  • Strong understanding of Microbiology related to drug substance or drug product manufacturing. 
  • Experience with relevant analytical laboratory equipment and software. 
  • Experience with GMP biologics manufacturing and related regulatory requirements including USP and EP compendial testing.  

COMPENSATION RANGE:

$87,417 - $104,900 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.

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