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 and cell and gene therapies. 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 AGC Biologics Quality team is looking for a (Senior) Manager, Quality Assurance- Lot Disposition. This position is responsible for the Quality oversight of product disposition activities, batch record review, and managing various Quality projects and programs. Key responsibilities for this role include establishing processes and procedures, in conjunction with corporate requirements, for reviewing batch records and other documentation required to disposition commercial drug product. The successful candidate will be able to work under minimal direction, have previous management experience, work collaboratively to solve complex problems, and ensure robust and compliant execution of the disposition process. Experience with cell and/or gene therapy is strongly preferred.
- Ensuring site QA policy and procedures are in place, are maintained current to corporate and regulatory requirements, and effectively meeting the needs of GMP Operations.
- Provide strong leadership, development, and oversite of direct/indirect reports.
- Batch record review.
- Batch disposition.
- Ensure training of staff (QA, QC, and Manufacturing) on documentation requirements for batch disposition.
- Quality Projects and Programs:
- Participate in Quality Management Review Program.
- Participate in Inspection Preparation and Management.
- Lead Quality Project Teams for Continuous Improvement.
- Proactively address GMP compliance concerns and resolve problems.
- Diplomatically partners with other departments/groups for corrections and problem solving.
- Review and approve Quality Assurance SOPs.
- Participate in GMP-related issue resolution.
- Provides direct supervision to exempt employees and/or skilled nonexempt employees.
- Assigns daily/weekly tasks to staff members.
- Performance appraisals.
- Participate in and facilitates teams supporting regulatory inspection readiness.
- Other duties as assigned.
KNOWLEDGE, SKILLS & ABILITIES:
- Knowledge of cell and/or gene therapy disposition requirements.
- Strong verbal and written communications skills.
- Excellent analytical and problem-solving skills.
- Ability to seamlessly manage a variety multiple project simultaneously.
- Outstanding customer service skills with the ability to work effectively with diverse groups at various levels within the company.
- Deeply well organized, flexible, and responsive.
- Good judgement with strong interpersonal relationship, team building, and collaboration skills.
- Willing and able to travel.
- Bachelors of Science in chemistry or life sciences or equivalent experience.
- 8+ years of relevant experience in a pharmaceutical or FDA/GMP environment.
- Experience with cell and/or gene therapy preferred.
- Management experience.
- Ability to understand and apply GMP regulations as they relate to manufacturing, test laboratory and facility operations.
- Experience in test method and process validation preferred.
- Demonstrated ability to effectively manage staff and multiple tasks utilizing organization and prioritization skills, driven to meet timelines, results-oriented.
$121,844 - $159,615
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