CBM

Full Time EE

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 Vector Drug Product Bioprocessing II Associate will be responsible for performing routine cGMP manufacture of viral vectors, non-viral vectors, and advanced therapeutics supporting the gene therapy asset at the Center for Breakthrough Medicines. The incumbent will be responsible for operating aseptic filling equipment and performing production support activities while maintaining compliance to cGMP standards. May be expected to support other areas of manufacturing when aseptic filling is not ongoing.

We are looking for individuals that have experience working within a team, are hard-working, and highly motivated. This position requires multi-tasking, interdepartmental coordination, and xcellent peer-to-peer communication skills. This position has the potential to evolve into a senior role.

Responsibilities

• Work in a hands-on capacity within a cleanroom environment to perform aseptic filling, inspection, labeling, and packaging of Drug Product. 
• Assist in maintaining the cGMP status of the manufacturing facility to always ensure inspection readiness. 
• Ensures work is completed in compliance with approved SOPs, batch records, controlled documentation, and all applicable regulations, guidelines, safety policies and procedures are followed. 
• Assist in the resolution of manufacturing deviations/non-conformances and troubleshooting of process and equipment problems. 
• Assist in validation activities related to the qualification of the manufacturing process, facility suites, and process equipment.

Qualifications

• High school diploma is required, but a bachelor’s degree in biological science(s) field or related engineering is preferred. 
• A minimum of 2 year of experience in cGMP biological manufacturing. Vector manufacturing or other gene therapy is highly preferred.  
• A minimum of 2 year of experience in cGMP biological manufacturing. Vector manufacturing or other gene therapy is highly preferred.  
• Working knowledge of cGMP regulations. 
• Experience working in a Biological Safety Cabinet (BSC). 
• Effective written and verbal communication skills, with excellent teamwork aptitudes. 
• Experience working with aseptic filling equipment and isolators is preferred. 
• Experience working with pipettes, and micropipettes. 
• Ability to work well independently, as part of a team, and establish working interdepartmental relationships. 
• Exhibits attention to detail, accuracy in work, and integrity of character. 
• Self-starter who shows ability to learn and problem-solve. 
• Exhibits technical aptitude to learn and operate production equipment. 
• Able to adhere to all safety and company regulations. 
• Able to accommodate a flexible work schedule to support business demands.

Physical Demands

• Able to carry up to 55lbs.
• Ability to stand for long periods of time while wearing PPE daily.

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.