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 Plasmid Bioprocessing Associate will be responsible for performing routine cGMP manufacture of plasmid DNA at the Center for Breakthrough Medicines. The incumbent will be responsible for operating upstream and/or downstream unit operations such as cell expansion, fermentation, filtration, and chromatography. Additional support activities such as media preparation, document review, and component preparation will be required while maintaining compliance to cGMP standards. We are looking for individuals that are willing to work within a team, are hard-working, and highly motivated. This position requires multi-tasking and excellent peer-to-peer communication skills. The incumbent will embrace and promote right-first-time culture.

Responsibilities

• Work in a hands-on capacity within a cleanroom environment to perform bioprocessing unit operations.
• 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.
• Proactively assist in the resolution of manufacturing deviations/non-conformances and troubleshooting of process and equipment problems.
• Identify opportunities for improvements in process, safety, quality, and cost.
• Provides timely technical input to support ongoing operations.

 Qualifications

• High school diploma is required, but a bachelor’s degree in biological science(s) field or related engineering is preferred.
• A range of 0-2 years of experience in cGMP biological manufacturing. Previous experience in the cell/gene therapy is highly preferred but not required.
• General knowledge of cGMP regulations.
• Experience working in a Biological Safety Cabinet (BSC).
• Experience with aseptic manipulation, pumps, sterile connections, and other common bioprocessing equipment is preferred.
• Ability to work well independently and as part of a team.
• Exhibits attention to detail, accuracy in work, and integrity of character.
• Self-starter who shows willingness to learn and problem-solve.
• Willingness 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

• Ability to carry up to 55 pounds.
• 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.