Associate, Manufacturing I

Purpose
Performs cGMP manufacturing operations in a biologics production environment, primarily upstream processing and buffer preparation.

Responsibilities
- Execute routine/non-routine cGMP manufacturing per approved batch records, SOPs, safety requirements, and current Good Manufacturing Practices.
- Prepare buffers/solutions/process materials; perform material transfers, sampling, in-process checks, and related quality activities.
- Operate, monitor, and support process equipment setup and calibration with technical/engineering personnel.
- Use systems (e.g., LIMS, SAP, LabX, Pi, SAIS, automated control platforms) to document work, review/evaluate data, and verify compliance.
- Make routine adjustments within defined limits to maintain process control, product quality, and efficiency.
- Support troubleshooting; investigate assigned deviations and escalate unusual conditions.
- Maintain accurate documentation (batch records, logs, electronic entries) and support continuous improvement.

Qualifications
- Bachelor’s degree (or equivalent) required.
- 2–5 years relevant experience; strong writing skills.
- Working knowledge of media/buffer preparation and cell culture or purification of biological drugs.
- Computer proficiency; knowledge of safety, quality systems, and cGMP; familiarity with tech transfer.
- Flexible, team-oriented, able to handle multiple tasks under pressure; professionalism and relationship-building.

Benefits (if applicable)
Paid time off; medical/dental/vision insurance; 401(k) (eligible employees); eligible for short-term incentive programs.