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 SUMMARYManages a team of Microbiology Technical Operations professionals. Leads and manages QC Microbiology method transfers and verification, new product on boarding, risk assessments, and other technical activities for the Microbiology Technical Operations team; assigns tasks and ensures team adherence to key milestones. Evaluates and monitors ongoing Microbiology environmental monitoring and utility monitoring, contamination control, method transfers and validations as well as ensures compliance with all applicable current regulatory standards for Microbiology.
ESSENTIAL JOB DUTIES/RESPONSIBILITIES- Manage the activities of the Microbiology Technical Operations Group supporting both the Longmont and Boulder, CO sites.
- Responsible for Microbiology Technical Operations team's adherence to standards, methods and procedures for QC Microbiology testing and method verification activities.
- Support and lead Contamination Control Strategies for the CO sites
- Ensure QC Microbiology Technical Operations team output conforms to regulatory and company standards and adheres to all applicable cGMP regulations.
- Manages daily operations for a project/team comprised of professional employees.
- Prioritizes and assigns technical resources internally and externally; ensures tasks are completed and work area/project goals and objectives are met.
- Coordinates and collaborates with other teams to meet organizational goals and work requirements.
- Train, coach, mentor, and develop team members on skill proficiency and performance with general direction on tasks and regular feedback.
- Provide key performance indicators and metrics for the Microbiology Technical Operations team
- Develop staff (i.e. set goals, assign development activities, review performance, etc.)
- Act as Subject Matter Expert for technical Microbiology related questions internally, externally and across sites and clients. Support regulatory and client audits as needed.
- Lead EM and Utility testing strategy and alignment activities across CO sites
- Support New Product on boarding activities for Microbiology, aseptic processes and sterility assurance risk assessments, and provide cross functional Microbiology support to key internal stakeholders.
- Ensure CO Microbiology laboratories remain in compliance with current regulatory requirements related to Microbiology testing, environmental and utility monitoring, and contamination control.
- Additional activities as required to support the Microbiology Technical Operations team
LEADERSHIP SKILLS- Begins to play a hand in professional development of others; may mentor less experienced employees on job duties and general departmental operations.
- Provides direct supervision to professional individual contributors and/or skilled, support and technical operations microbiology staff.
QUALIFICATIONS Required:- BS/BA degree with 8+ years of industry experience, or Master's degree with 6+ years of industry experience. Equivalent education and experience may substitute for stated requirements.
Preferred: - Experience with facility contamination control, Environmental and Utility Monitoring. Microbiology QC method verification and validation, subject matter and technical expert experience for Microbiology related deviations and aseptic/sterility assurance process improvement activities
COMPENSATION$94,000 - $129,250
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.