Vector Drug Product Bioprocessing Associate I
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Vector Drug Product Bioprocessing Associate I

King of Prussia, PA

The 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.

Summary

The Vector Drug Product Bioprocessing I Associatewill be responsible for performing routine cGMP aseptic filling 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 fillers and isolators and performing production support activities while maintaining compliance to cGMP standards. In addition, operators will perform visual inspection of finished product. Operators will be expected to assist in other areas when Drug Product fills are not occurring.

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. 

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. 
  • 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 range of 0-2 years of experience in cGMP biological manufacturing. Vector manufacturing or other gene therapy is highly preferred.  
  • General knowledge of cGMP regulations. 
  • Experience working in a Biological Safety Cabinet (BSC). 
  • General knowledge of aseptic filling equipment and isolators. 
  • 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.  


Education & Experience

  • 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. Vector manufacturing or other gene therapy is highly preferred.  


Physical Demands

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

Compensation: TBD

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