Quality Control Scientist I

Our purpose is to bring hope to life by enabling lifechanging 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 crossfunctional 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) subvisible 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 crossfunctional 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 Subvisible 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.

• Indepth 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 crossfunctional teams management and stakeholders.

• Demonstrated ability to collaborate effectively with crossfunctional 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..

  • Handson 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

$83920 $115390

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 sidebyside with our clients and partners every step of the way. We provide worldclass development and manufacture of mammalian and microbialbased 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 cGMPcompliant facilities in Seattle Washington; Boulder and Longmont Colorado; Copenhagen Denmark; Heidelberg Germany; Milan Italy; and Chiba Japan. We currently employ more than 2500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients most complex challenges including specialization in fasttrack projects and rare diseases. AGC Biologics is the partner of choice. To learn more visitwww.agcbio.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.