What are the responsibilities and job description for the Director, Quality Control position at AGC Biologics, Inc.?
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:
As the Director of Quality Control, you will lead the Quality Control department across our two Colorado sites (Boulder and Longmont). In this key leadership role, you will drive strategic decision-making, ensure phase-appropriate cGMP compliance, and oversee all QC laboratory operations for our biologics business. Your responsibilities will include building and developing a high-performing management team, optimizing QC processes, and aligning department objectives with organizational goals.
Additionally, you will manage budget and resource planning, lead cross-functional initiatives, and provide expert support for client audits and regulatory inspections.
PRINCIPLE RESPONSIBILITIES:
- Ensure compliance and business deliverables are met for mammalian QC programs
- Make strategic department and project decisions
- Forecast and manage resources and budget needs
- Oversee the on-time delivery of raw materials, in-process samples, and Bulk Drug Substance
- Establish key metrics to determine department performance
- Provide mentoring and career development to employees
- Oversee QC regulatory compliance and manage the efficiency of operations and continuous improvement activities
- Provide expert technical analysis and evaluation of Quality Control issues impacting projects for mammalian operations processes
- Interact with clients during CDMO selection and throughout projects for problem-solving
KNOWLEDGE, SKILLS, AND ABILITIES:
- Ability to direct a 24/7 Quality Control laboratory operation, including oversight of management and technical employees
- Ability to manage department budget and resources
- Ability to work in a highly dynamic environment, including working with and through others to accomplish goals
- Knowledge and expertise in mammalian testing, including instrumentation, analytical method transfers, and analytical method validation
- Knowledge of microbiological and environmental monitoring methods and practices for a low-bioburden facility
- Experience in leading change management efforts in support of a growing and dynamic business
- Experience participating in regulatory inspections
- Experience in all aspects of GMP QC laboratory management
- Knowledge of US and EU regulatory requirements concerning Quality Control
- Ability to solve technical and quality analytical problems
- Expertise in the development of product specifications and stability studies, including the review and approval of analytical test results, controlled documents, and validation protocols/reports
- Strong interpersonal, written, and oral communication skills
EDUCATION/EXPERIENCE:
- Bachelor's degree with 12 years of industry experience, Master’s degree with 10 years of industry experience, or PhD with 7 years of industry experience
- Minimum of 5 years management experience in a GMP Quality Control Laboratory
- Equivalent education and experience may substitute for stated requirements
COMPENSATION RANGE:
$164,400 - $226,050
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.
Salary : $164,400 - $226,050
