The Plasmid Bioprocessing Associate will be responsible for performing routine cGMP manufacture of plasmid DNA at the Center for Breakthrough Medicines. The incumbent will be responsible for operating upstream and/or downstream unit operations such as cell expansion, fermentation, filtration, and chromatography. Additional support activities such as media preparation, document review, and component preparation will be required 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. The incumbent will embrace and promote right-first-time culture.
- Work in a hands-on capacity within a cleanroom environment to perform bioprocessing unit operations.
- 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.
- Proactively assist in the resolution of manufacturing deviations/non-conformances and troubleshooting of process and equipment problems.
- Identify opportunities for improvements in process, safety, quality, and cost.
- Provides timely technical input to support ongoing operations.
- High school diploma is required, but a bachelor’s degree in biological science(s) field or related engineering is preferred.
- A range of 0-2 years of experience in cGMP biological manufacturing. Previous experience in the cell/gene therapy is highly preferred but not required.
- General knowledge of cGMP regulations.
- Experience working in a Biological Safety Cabinet (BSC).
- Experience with aseptic manipulation, pumps, sterile connections, and other common bioprocessing equipment is preferred.
- 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.
- Ability to carry up to 55 pounds.
- Ability to stand for long periods of time while wearing PPE daily.
As an Equal Opportunity Employer, we believe in each person’s potential. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, sexual orientation, gender identity, disability or any other protected category including veteran status.