Summary
The Vector Upstream Bioprocessing employee 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 upstream equipment for adherent and suspension systems and performing production support activities 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.
Responsibilities
- Work in a hands-on capacity within a cleanroom environment to perform cell culture scale-up and operate single use bioreactors.
- 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.
Education & Experience
- High school diploma is required, but a bachelor’s degree in biological science(s) field or related engineering is preferred.
- 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 cell expansion vessels.
- 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.
