The Vector Upstream Bioprocessing IIIAssociatewill be responsible for performing routine cGMP manufacture of viral vectors, non-viral vectors, and advanced therapeutics supporting the genetherapy asset at the Center for Breakthrough Medicines.The incumbent will be responsible foroperatingupstream equipmentfor adherent and suspension systemsand performingproductionsupportactivitieswhile maintaining compliance to cGMP standards. This position willparticipate in theonboarding and training ofthe inaugural manufacturing staff for the stand upofa new organization.
We are looking for individualsthathave experience working withina team,arehard-working, highly motivated,andsolution oriented.This position requires multi-tasking,interdepartmental coordination,and excellentpeer-to-peercommunicationskills.Thisposition hasthe potentialtoevolve into a lead role.
- Work in a hands-on capacity within a cleanroom environment toperformcell culturescale-up and operatesingle use bioreactors.
- Assist in maintaining thecGMP status of the manufacturing facilitytoalways 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 ofprocess andequipmentproblems.
- Assists with the training of Bioprocessing associates.
- Assist in validation activitiesrelated tothe qualification of themanufacturing process, facilitysuites, andprocessequipment.
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 bioreactors, aseptic operations, cell culture, and seed scale-up 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 incubators, pipettes, and micropipettes.
- Experience working with sterile tube welders, sterile tube sealers, and cell counting machines.
- Experience working with of cell expansion vessels such as T-flasks or shake flasks.
- 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.