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 Investigator will own and investigate all Manufacturing related deviations. The Deviation Investigator will work with cross functional stakeholders to perform simple and complex root cause analysis to root cause and identify corrective actions to close assigned investigations on time.

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

• Investigation of manufacturing deviations to determine root cause and implementation of corrective actions to prevent recurrence.
• Work with cross functional teams to gather data, lead and perform Root Cause Analysis to determine the likely root cause of the event.
• Assessment of event for overall impact.
• Identification of Corrective and Preventative actions to prevent recurrence.
• Management of multiple investigations concurrently.
• Provide routine client updates to communicate status and alignment on investigation findings.
• Ability to communicate roadblocks and challenges in a timely manner that can impact task and timely delivery of investigation.

Qualifications

• BS in Life Sciences or Engineering discipline required; Master’s degree preferred
• 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.
• Prior experience in Manufacturing Environment or troubleshooting Manufacturing related issues preferred.
• Excellent verbal and written communication skills.
• Excellent interpersonal 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.
• Ability to prioritize tasks.
• Ability to work well on a team.
• 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.