Director, QC Microbiology

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

Quality Control (QC) is seeking an experienced Director to lead our QC Microbiology department. In this critical role, you will be responsible for providing strategic direction and technical expertise to ensure the microbiological safety, quality, and compliance of our clients' biopharmaceutical products, from clinical phase I through to commercial supply.

Your focus is to empower team members to secure Customer deliverables, as well as to lead and develop QC Microbiology in accordance with our Company Core Values of Teamwork, Quality, Trust, Knowledge, Ingenuity and Accountability. You are expected to develop your employees, build capabilities, secure transparency, optimize resource prioritization and collaborate proactively in the leadership team and in cross-organizational collaborations.

Qc Microbiology Department

QC Microbiology is one of six departments in the QC area. QC Microbiology covers both the safety testing of products, and the environmental monitoring of our cGMP manufacturing facilities.

The QC Microbiology department consists of 28 employees divided into 3 teams. Each team is lead by a manager who will be reporting into you.
It is a well-functioning department of highly skilled and passionate scientists and technicians. They are responsible for supporting the production of biopharmaceuticals by performing analytical testing and validating analytical procedures according to ICH guidelines, as well as interacting with customers and authorities on method related topics. Moreover, there is close collaboration with departments across the QC area and with stakeholders internally in AGC Biologics. Finally. the QC Microbiology department is responsible for the daily execution of the environmental monitoring program for the GMP manufacturing facilities.

As Director of QC Microbiology, you will report directly to the Senior Director of QC and will be part of the QC leadership team.

Key Responsibilities

• Develop and manage the long-term vision for QC Microbiology, ensuring alignment with overall site goals, client needs, and global regulatory expectations.
• Lead, mentor, and empower a high-performing team of managers, scientists and technicians, fostering a culture of scientific integrity and operational excellence.
• Manage departmental resources, including staffing, and laboratory capacity, to effectively support a dynamic portfolio of client projects.
• Ensure the Microbiology laboratories operate in a state of constant inspection readiness, maintaining full compliance with cGMP and regulatory standards. Support during regulatory inspections and audits.
• Oversight of all activities to ensure timely testing to meet production and project timelines.
• Act as a key technical expert and senior point of contact for clients on all microbiological matters, providing expert guidance and building strong, trust-based relationships.
• Drive the evaluation and implementation of new technologies within the department to enhance efficiency, safety, and compliance.

Qualifications

• Education: You hold a Master's degree or Ph. D. in natural sciences (e.g. Pharmacy, Molecular Biology, or a related life sciences field).
• Experience: You have a minimum of 8+ years of relevant experience in the pharmaceutical industry, with at least 5+ years in a leadership role with experience leading other managers. Experience in a CDMO environment is a significant plus.
• Leadership: Proven leadership, coaching, and mentoring skills with the ability to build and motivate a high-performance team. You are an analytical, pragmatic, and change-oriented leader with a proactive approach to delivering results and a natural ability to manage multiple priorities in a fast-paced environment.
• Technical Expertise: You possess strong knowledge of microbiological testing methods, environmental monitoring in a manufacturing setting, and method validation strategies.
• Regulatory Knowledge: You have an in-depth knowledge of cGMP and global regulatory requirements.
• Communication: You are an excellent communicator and have a strong proficiency in written and spoken English. 
• Your Application
• Apply as soon as possible. We treat the applications as we receive then, and conduct interviews with qualified candidates. When the right candidates are found, the ad will close.

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.