The Manufacturing Support Services II Associate will be responsible for performing routine cleaning and assembling activities that aid in the production of gene therapies. The incumbent will be responsible for supporting the manufacture of viral vectors, non-viral vectors, and advanced therapeutics while maintaining compliance to cGMP standards.
We are looking for individuals that have experience working within a team, are hard-working, and highly motivated. This position requires multi-tasking, interdepartmental coordination, and excellent peer-to-peer communication skills. This position has the potential to evolve into a senior role.
- Work in a hands-on capacity to prepare buffers, assemble jumper harnesses, and clean/sterilize equipment and materials.
- Work closely with manufacturing personnel by transferring/stocking critical materials and delivering samples throughout the facility.
- Clean GMP spaces, collect waste from production suites, and perform decontamination protocols.
- 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 support deviations/non-conformances and troubleshooting of support process and equipment problems.
- Assist in validation activities related to the qualification of the manufacturing support process, facility suites, and 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 1-3 years of experience in cGMP biological manufacturing. Contract, Development, and Manufacturing Organization (CDMO) experience 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 autoclaves, washers, aseptic operations, and cleanroom decontamination is preferred.
- Experience working with pipettes, micropipettes, and scales.
- Working knowledge of cleanroom behavior.
- 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.