CBM

Full Time EE - Hybrid

Center for Breakthrough Medicines is on track to be the largest single-site cell and gene therapy contract development and manufacturing organization in the world. Our comprehensive service offering accelerates speed to market through supply chain disruption mitigation strategies, end-to-end program management expertise and unique platform technology with the ability to follow a molecule from idea to commercialization. CBM’s integrated approach provides high quality and consistent end-to-end manufacturing capability including: Process and Analytical Development; Plasmid DNA production; Viral Vector Production of Lentivirus; AAV and Adenovirus; Testing and Analytics; Autologous, Allogeneic and Gene-edited Cell Therapy Bioprocessing; and Cell banking. CBM’s horizontal and vertical integration provides one source throughout a product’s life cycle.

CBM’s mission is to accelerate the delivery and affordability of lifesaving and life-changing therapies from discovery to market by offering a complete solution for the development and commercialization of cell and gene therapies.

CBM is located just outside of Philadelphia in the Heart of Cellicon Valley on The Discovery Labs campus set on 300 acres with 2.4 million square feet of life sciences lab and manufacturing space, allowing clients to scale their development and manufacturing needs without ever having to change sites, while providing employees a true community campus experience focused exclusively on life sciences.

Summary

The Deviation and Quality Records Supervisor will provide investigation leadership and compliance support for Viral Vector Manufacturing deviations as well as oversight of Corrective and Preventative actions. The Supervisor will work with stakeholders to perform complex root cause analysis and identify corrective actions and ensure the Viral Vector Manufacturing team is audit ready.

The role will support all aspects of the Viral Vector Philosophy, Strategy, and Execution Plan to make Center for Breakthrough Medicines (CBM) a best-in-class Contract and Development Manufacturing Organization (CDMO).

Responsibilities

•  Direct supervision of a team of investigators.
•  Coaching and mentoring investigators on common root cause analysis techniques.
•  Provide oversight of investigations management to ensure timely and compliant closure in collaboration with Quality Assurance.
•  Report metrics for investigation activities.
•  Attend appropriate meetings to report out on investigations and investigation metrics for Manufacturing Operations.
• Presentation of critical investigation findings to key stakeholders and senior leadership.
• Actively develop, promote, and implement safe work practices to ensure safe working conditions for all employees while maintaining permanent inspection readiness

Qualifications

• BS in Life Sciences or Engineering discipline required; Master’s degree preferred
• 3 to 5 years of related pharmaceutical experience required, including relevant experience in manufacturing in a GMP environment
• Experience utilizing root causes analysis tools and identifying corrective and preventative actions is required.
• Experience with viral vector manufacturing/support preferred
• Excellent verbal and written communication skills.
• Excellent interpersonal and customer service skills.
• Excellent sales and customer service skills.
• Excellent organizational skills and attention to detail.
• Excellent time management skills with a proven ability to meet deadlines.
• Strong analytical and problem-solving skills.
• Strong supervisory and leadership skills.
• Ability to prioritize tasks and to delegate them when appropriate.
• Ability to lead multi-disciplinary project teams.
• Ability to function well in a high-paced and at times stressful environment.
• Proficient with Microsoft Office Suite or related software.
• Ensures accuracy and relevance of assigned training curriculum.
• Drives timely completion of training for employees to meet regulatory requirements

As an Equal Opportunity Employer, we believe in each person’s potential. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, sexual orientation, gender identity, disability or any other protected category including veteran status.