The Vector Downstream BioprocessingII Associate will 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 foroperatingdownstream equipmentfor adherent and suspension systemsand performingproductionsupportactivitieswhile maintaining compliance to cGMP standards.
We are looking for individualsthathave experience working withina team,arehard-working, and highly motivated.This position requires multi-tasking,interdepartmental coordination,and excellentpeer-to-peercommunicationskills.Thisposition hasthe potentialtoevolve into a senior role.
- Work in a hands-on capacity within a cleanroom environment tooperatechromatography systems, ÄKTA chromatography controllers, UF/DF systems, ultracentrifuges, and perform sterile filtrations.
- 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.
- 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 2 year of experience in cGMP biological manufacturing. Vector manufacturing or other gene therapy experience is highly preferred.
- Working knowledge of cGMP regulations.
- Experience working in a Biological Safety Cabinet (BSC).
- Effective written and verbal communication skills, with excellent teamwork aptitudes.
- Experience working with single-use chromatography and UF/DF systems, ultracentrifuges, integrity testers, and aseptic operations is preferred.
- Working knowledge of viral vector purification methods for gene therapy products.
- 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 ability to learn and problem-solve.
- Exhibits 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.