AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply. Right. On time. For more information, visit www.agcbio.com .
The QC Equipment Manager will provide leadership for QC GMP Capital Projects and Equipment Management. This position will provide direction for execution of equipment onboarding, maintenance program and long range plan for growth in alignment with site priorities within the Quality Control Department. The ideal candidate will be an expert in laboratory compliance, developing interdepartmental relationships and possess strong project management skills.
- Serve as Process Transfer representative on client project teams.
- Lead activities and change controls for new equipment, maintenance of existing equipment and decommissioning of aged equipment.
- Develop equipment lifecycle program.
- Participate in site projects and be the QC representative on capital investments for site growth.
- Lead and mentor staff with regards to technical knowledge for equipment and QC validation processes.
- Use project management skills to facilitate prioritization and scheduling of QC equipment.
- Define and provide user requirements for new equipment associated with multiple laboratories in support of GMP testing.
- Lead project team meetings, make decisions, and create milestones representing the equipment program.
- Identifying new technologies set to improve testing capabilities.
- Maintain and report equipment utilization and equipment downtime metrics.
- Able to successfully influence other groups within the company with positive outcomes for the organization
KNOWLEDGE, SKILLS & ABILITIES:
- Must be self-motivated, organized and proactive.
- Ability to coordinate multi-departmental tasks and deliverables (interaction with Process Development, Engineering, QA, MSAT, etc.).
- Proven experience successfully managing multiple projects simultaneously.
- Demonstrated ability to build effective working relationships across departments (MSAT, Process Development, Project Management and Business Development) to support new processes and products.
- Demonstrated experience leading troubleshooting efforts.
- Strong communication skills necessary to interact with internal stakeholders.
- Strong presentation skills.
- BS in Life Sciences discipline such as Biochemistry, Chemistry, Biology or related field required
- Minimum of 5 years of experience in the biotechnology or pharma industry with experience in biologics
- Minimum of 5 years of experience in managing staff
- Must have experience with and demonstrated understanding of Good Manufacturing Practices (GMP) and applicable regulations (e.g., 21 CFR Part 211, etc.).
- Experience with relevant analytical lab equipment and computers
- Must have experience writing, reviewing and approving GMP documentation.
- Equivalent education and experience may substitute for stated requirements.
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