Quality Control Scientist I

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

JOB SUMMARY

We are seeking a highly skilled and motivated Quality Control Microbiology Scientist I to provide technical and compliance leadership within the Quality Control department. This role will focus on laboratory testing, data review, report authoring, and designing verification studies/protocols. The ideal candidate will collaborate with cross-functional teams to support manufacturing processes, drive microbiological testing and investigations, and ensure compliance with GMP quality systems.

The ideal candidate will have extensive expertise in biopharmaceutical microbiology , GMP laboratory skills and a strong understanding of cGMP regulations (FDA, EU, JP, ICH) as applicable to QC operations. This role may oversee microbiology programs and potentially interact with QC analysts as a project lead.

Experience in a GMP microbiology laboratory is required.

ESSENTIAL JOB DUTIES AND RESPONSABILITIES

• Conduct laboratory testing, review data, and author technical reports and protocols.

• Design and execute verification studies and validation protocols.

• Support manufacturing processes by providing microbiological expertise and troubleshooting.

• Lead microbiological investigations and implement corrective actions as needed.

• Ensure compliance with cGMP regulations (FDA, EU, JP, ICH) and maintain GMP quality systems.

• Oversee aseptic process simulations, bioburden testing, container closure integrity testing (CCIT), sub-visible particle analysis, endotoxin testing, and culture identification.

• Manage environmental and utility monitoring programs.

• Act as a project lead or owner for specific microbiology programs, potentially overseeing QC analysts.

• Drive process improvements and implement best practices using Lean methodologies.

• Communicate effectively both verbally and in writing, fostering collaboration across teams.

• Adapt to a rapidly changing environment and balance multiple priorities simultaneously.

• Represent QC Technical Operations on cross-functional teams and prepare and present data to internal and external clients.

• Assist with microbial identifications and objectionable organism assessments.

• Implement new laboratory testing technologies and rapid methods.

• Initiate and complete deviations, invalid assay investigations, and laboratory investigations.

• Act as subject matter expert on microbiological assays, method qualification, technical troubleshooting, and instrument validation.

• Contribute to continuous improvement initiatives and laboratory investigations.

• Author, review, and approve procedures, specifications, verification, and validation documents.

• Implement change controls, lead investigations, and complete CAPAs in support of cGMP operations.

• Conduct gap analysis to align with USP, EP, JP, EU, ICH, FDA and other guidance document requirements.

• Contribute to deviation investigations, CAPAs, and analytical troubleshooting.

• Support and provide oversight in the preparation of quarterly and annual reports, trend investigations, statements of quality, and other applicable reports.
   

FUNCTIONAL KNOWLEDGE

• Comprehensive understanding of GMP laboratory operations related to microbiological and chemical assays related to drug production.

• Proficiency in analytical methods across a broad range of microbiological testing technologies, including (but not limited to) Bioburden, Endotoxin, Aseptic Process Simulation (APS), Container Closure Integrity Testing (CCIT), Microbial Identification, Environmental and Clean Utility Monitoring, Sub-visible Particle Analysis, Contamination Control, and Sterility Testing.

• Strong analytical skills with the ability to interpret, assess, and perform risk analysis on complex data to support business processes.

• Exceptional technical writing, communication, and data management skills.

TECHNICAL & LEADERSHIP SKILLS

• Extensive knowledge and experience in cGMP biopharmaceutical manufacturing, regulatory requirements, contamination control, environmental monitoring, and QC microbiological testing.

• In-depth understanding of GMP guidelines and international regulations related to the production of APIs and drug products, including USP, EP, JP, EU, ICH, and FDA standards.

• Ability to act as a Microbiology Subject Matter Expert during client audits and regulatory inspections.

• Strong technical writing and verbal presentation skills, with the ability to effectively communicate complex information to cross-functional teams, management, and stakeholders.

• Demonstrated ability to collaborate effectively with cross-functional teams to achieve deadlines and objectives.
   

EDUCATION & EXPERIENCE

• Education: Minimum of a Bachelor of Science (BS) degree, preferably in Microbiology, Biochemistry, or other Biological Sciences. A Master of Science (MS) degree is preferred.

• Experience:

  • Minimum of 8+ years of relevant experience with a BS degree, or 5+ years with an MS degree, in Quality Control testing within a regulated environment (GMP, GLP, etc.).

  • Hands-on experience with compendial microbiological methods, including USP <61> Bioburden, USP <85> Endotoxin testing, and data evaluation and trending.

  • Extensive experience in contamination control, sterility assurance, aseptic processes, and environmental monitoring of controlled cleanroom areas.

  • Proficiency with analytical laboratory instruments and software relevant to microbiological testing.

  • Experience interacting with FDA or other regulatory agencies is strongly preferred.
     

COMPENSATION

$83,920 - $115,390

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe. 

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.  Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!

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.