This is a night shift supervisory role. Hours are Monday-Friday 10pm-6:30am
Key Responsibilities:
- Perform and oversee downstream processes at various scales in a cGMP environment, including column packing, troubleshooting, and data analysis.
- Provide technical leadership in the execution and development of purification processes.
- Use software tools to collect and evaluate operating data and make on-the-fly adjustments to products, instruments, or equipment.
- Prepare and review quality management documents (deviations, change controls, investigation reports, etc.).
- Ensure timely execution of engineering and clinical batches.
- Establish equipment specifications and improve manufacturing techniques.
- Collaborate with cross-functional teams and external vendors to resolve technical issues and maintain production equipment.
- Lead adherence to GMP practices and environmental health and safety policies.
- Coordinate investigations and corrective actions for issues encountered during batch execution.
- Perform additional tasks as assigned.
- Comply with all company policies and industry standards.
Qualifications:
- Bachelor's or Master's degree in chemical, biological, or biochemical sciences.
- 7-10 years of relevant experience in the biopharmaceutical industry.
- Experience in GMP and aseptic manufacturing environments.
- Proficiency with AKTA Process skids or similar systems, and knowledge of single-use manufacturing consumables (bags, tube sets, columns, process manifolds).
- Familiarity with executing engineering and clinical batches, and understanding GMP documentation.
- Knowledge of cleaning verification/validation.