Sr Manufacturing Associate - Shift B

Responsibilities

• Execute upstream and downstream GMP manufacturing activities according to approved batch records and SOPs.
• Perform cell thaw, inoculum expansion, bioreactor, harvest, purification, filtration, and bulk drug substance operations.
• Set up, operate, monitor, and maintain manufacturing equipment and single-use processing systems.
• Perform aseptic operations in cleanroom environments.
• Serve as a technical resource for manufacturing equipment and processes.
• Assist with training and qualification of Manufacturing Operators.
• Provide guidance on GMP documentation and aseptic technique.
• Support onboarding and development activities.
• Troubleshoot process, equipment, and operational issues.
• Partner with QA, QC, MSAT, Engineering, Facilities, Supply Chain, and Program Management.

Qualifications

• BA/BS degree that included laboratory work in a chemistry, biology, or related field.
• At least 2 - years of purification experience in a GMP pharmaceutical/biotech environment role.
• Demonstrate knowledge and understanding of cGMPs and how they apply to responsibilities.
• Skilled in aseptic handling, including BSC operations to maintain the integrity of sterile systems.
• Skilled with using single-use technologies.
• Strong technical and mechanical aptitude in bioprocessing.
• Knowledge of purification using column chromatography.
• Skilled in leading, training, and coaching peers.
• Computer proficiency.
• A proven ability to confidently compute basic arithmetic operations.