Supervisor, Quality Control - Microbiology

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:

This position is Sunday - Wednedsay 4x10, 8am-6pm

We are looking for an experienced Quality Control Supervisor-Microbiology to join the AGC Biologics team.  This position will represent QC for routine testing and environmental monitoring within   controlled GMP manufacturing areas. The position will manage and schedule QC testing and environmental monitoring, work with cross functional teams to support manufacturing processes and support Microbiological testing and investigations. The role will mentor and train junior laboratory personnel in microbiological methods, environmental monitoring, and contamination control processes.

A strong background in environmental monitoring, microbial investigations, risk assessments, microbiological support of aseptic processes and QC microbiology test methods is highly desired.  A background in Quality Control Microbiology and contamination control related to Biopharmaceutical or pharmaceutical manufacturing is required.

KEY RESPONSIBILITIES:

• Represent QC on teams, prepare and present data to internal and external clients
• Implement new laboratory testing technologies and rapid methods
• Perform QC testing/environmental monitoring as well as scheduling of laboratory testing
• Manage a team of analysts to support QC laboratory operations
• Assist with microbial identifications and objectionable organism assessments
• Author sample plans, test methods, and specifications to support in-process, drug substance release testing, and environmental monitoring.
• Highly motivated and self-driven individual with the ability to work independently, and multi-task under aggressive timelines to support department and business objectives
• Contribute to laboratory investigations, deviations, CAPAs and analytical troubleshooting
• Develop staff goals and perform performance reviews
• Manage and report on sample status and review laboratory data  
• Ensure QC Microbiology laboratory maintains regulatory compliance and is up to date on current industry best practices

KNOWLEDGE, SKILLS AND ABILITIES:

• Strong knowledge and experience of cGMP biopharmaceutical manufacturing, regulatory requirements, contamination control, environmental monitoring  and QC Microbiological testing
• Excellent analytical, technical writing, communication and data management skills
• Contribute expertise in analytical methods across a wide range of technologies for the analysis of peptides/ proteins related to microbiological purity
• Ability to analyze and risk assess complex data in support of manufacturing processes
• Ability to understand analytical/technical data
• Clear, concise writing skills
• Ability to interact constructively with co-workers in a cross functional environment

EDUCATION / EXPERIENCE:

• Education: Minimum BS, but preferably an advanced degree in Microbiology, Biochemistry or other Biological Science  
• Experience: Minimum of 2+ years' hands-on experience with environmental monitoring, data, Quality Control testing such as USP <61> bioburden, USP <85> endotoxin testing, and compendial microbiological methods in a regulated environment (GMP, GLP, etc.). 
• Experience in contamination control, sterility assurance, aseptic processes, and environmental monitoring of controlled cleanroom areas
• Previous management or supervisory experience preferred 
• Experience with relevant analytical laboratory instruments and software

COMPENSATION RANGE:

$ 83,920 - $115,390 

Fluctuations in the job market may necessitate adjustments to pay ranges. Final pay determinations will depend on various factors, including, but not limited to experience levels, knowledge, skills, and abilities.

Benefits available to Team Members include subsidized insurance for the Team Member and designated dependents (medical, vision, dental, life and disability), eligibility to participate in the AGC Biologics 401(k) plan (including a generous matching contribution from the company and immediate vesting), vacation, sick time, and parental leave.

Team Members are also eligible to receive a discretionary annual bonus commensurate to the level of the role. The payout is based on both the company's performance and the Team Member's performance.

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.