Director Quality Control

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:
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 decisionmaking ensure phaseappropriate cGMP compliance and oversee all QC laboratory operations for our biologics business. Your responsibilities will include building and developing a highperforming management team optimizing QC processes and aligning department objectives with organizational goals.

Additionally you will manage budget and resource planning lead crossfunctional 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 ontime delivery of raw materials inprocess 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 problemsolving
  

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 lowbioburden 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:

• Bachelors degree with 12 years of industry experienceMasters degree with 10 years of industry experience orPhD 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:

$164400 $226050

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 visit.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.