Associate Pilot Plant

We are seeking a highly motivated Associate Pilot Plant to support the execution of cell culture and downstream purification processes. This role will be supporting cell culture and downstream purification processes. You will work in a fast-paced biotech environment, collaborating with a team of scientists and engineers to carry out process studies.

Responsibilities:

• Perform aseptic vial thawing, cell culture flask passaging, and seed train expansion using benchtop wave bioreactors, 200L, and 500L single-use bioreactors.
• Monitor and document critical process parameters to ensure consistent performance.
• Troubleshoot cell culture deviations and suggest process optimizations when needed.
• Execute large-scale harvest operations, including chromatography, filtration, and Ultra-Filtration/Diafiltration (UF/DF).
• Operate and maintain pilot-scale skids and automated downstream processing equipment.
• Compound and prepare media and buffer solutions according to established protocols.
• Ensure proper storage and inventory management of materials and reagents.
• Assemble, disassemble, and perform routine maintenance on laboratory and production equipment.
• Conduct Clean-In-Place (CIP) and Steam-In-Place (SIP) operations for bioreactors and other systems.
• Collaborate with engineering and maintenance teams to troubleshoot equipment issues.
• Perform in-process sampling and analyze samples using laboratory instruments.
• Maintain an electronic laboratory notebook to document experimental data and process deviations.
• Compile process data and create detailed reports for analysis and decision-making.
• Adhere to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Perform routine laboratory safety evaluations and enforce safety standards.
• Participate in internal audits and inspections to ensure compliance with regulatory requirements.
• Escort and oversee external vendors and contractors during on-site activities.
• Assist in technology transfer and scaling activities by supporting experimental designs and operational execution.
• Provide training to junior staff and new team members as required.
• Maintain a clean and organized laboratory environment.
• Manage laboratory inventory, including ordering and stocking supplies.
• Identify opportunities for process improvements and contribute to their implementation.

Requirements

Qualifications:

• Bachelor’s degree in Engineering or Science.
• Associate degree and 1+ year of experience in a laboratory or manufacturing setting.
• High school diploma/GED and 2+ years of experience in a laboratory or manufacturing setting.
• Ability to work weekends is required.

Preferred Qualifications:

• Hands-on experience with pilot- or large-scale cell culture or downstream purification processes.
• Familiarity with automated, computer-controlled biopharmaceutical equipment.
• Proficiency in process data compilation and analysis.
• Strong problem-solving skills and excellent attention to detail.
• Effective written and verbal communication skills.