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.
The Vector Downstream Bioprocessing III 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 downstream equipment for adherent and suspension systems and performing production support activities while maintaining compliance to cGMP standards. This position will participate in the onboarding and training of the inaugural manufacturing staff for the stand up of a new organization.
We are looking for individuals that have experience working within a team, are hard-working, highly motivated, and solution oriented. This position requires multi-tasking, interdepartmental coordination, and excellent peer-to-peer communication skills. This position has the potential to evolve into a lead role.
- Work in a hands-on capacity within a cleanroom environment to operate chromatography systems, ÄKTA chromatography controllers, UF/DF systems, ultracentrifuges, and perform sterile filtrations.
- 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.
- Assists with the training of Bioprocessing associates.
- Assist in validation activities related to the qualification of the manufacturing process, facility suites, and process equipment.
Education & Experience
- High school diploma is required, but a bachelor’s degree in biological science(s) field or related engineering is preferred.
- A minimum of 3 years of experience in cGMP biological manufacturing. Vector manufacturing or other gene therapy experience is highly preferred.
- Strong knowledge of cGMP regulations.
- Experience working in a Biological Safety Cabinet (BSC).
- Strong written and verbal communication skills, with excellent teamwork aptitudes.
- Experience working with single-use chromatography and UF/DF systems, ultracentrifuges, and aseptic operations is highly preferred.
- Demonstrated ability to troubleshoot and resolve equipment and processing issues.
- Strong knowledge of process validation practices for biopharmaceutical products.
- Proven efficiency working in a Biological Safety Cabinet (BSC).
- Experience working with single-use mixers, sterile tube welders, sterile tube sealers, turbidimeters, and integrity testers.
- Proven 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 eagerness to learn and problem-solve.
- Innovative and efficient when solving problems with a focus on continuous improvement.
- Possesses 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.
- Ability to carry up to 55 pounds.
- Ability to stand for long periods of time while wearing PPE daily.