Senior Manufacturing Associate, Downstream

Position Overview

Under general supervision, the Senior Manufacturing Associate, Downstream will perform routine manufacturing activities in GMP manufacturing areas, including purification and the associated sub‐processes/preparation. Operations are executed according to established Standard Operating Procedures (SOPs) and batch records, including performing manufacturing steps, executing routine batch records, and revising documents as needed. The role drives projects and assignments while providing mentorship to associates. A flexible shift schedule and overtime may be required.

Key Responsibilities

• Perform moderately complex tasks using defined protocols or procedures to achieve project milestones.
• Conduct GMP manufacturing activities in assigned areas.
• Set up, operate, maintain, and clean downstream bioprocessing equipment, including chromatography systems, UF/DF units, viral filtration skids, and mixers.
• Perform basic troubleshooting of bioprocess equipment.
• Execute manual cleaning and sterilization of manufacturing areas, parts, and components.
• Follow SOPs, cGMP guidelines, plant safety protocols, and established procedures to ensure quality product production.
• Accurately complete and maintain detailed equipment logs and batch records in line with Good Documentation Practices (GDP).
• Draft and revise SOPs and batch records as needed.
• Participate in team meetings to discuss ideas, troubleshoot issues, review lessons learned, and plan future projects.
• Provide mentoring and coaching to colleagues and act as lead when Specialist/Supervisor is unavailable.
• Address production issues and report any compliance-related concerns immediately.
• Foster teamwork and propose project improvements.

Required Qualifications

• Education and Experience:
• Advanced degree in life sciences or a related discipline with 3 years of experience in the pharmaceutical or biotech industry, or equivalent education and experience.
• Bachelor's degree with 6 years of experience in the pharmaceutical or biotech industry, or equivalent education and experience.
• High School Diploma/GED with 8 years of experience in the pharmaceutical or biotech industry, or equivalent education and experience.
• Knowledge, Skills, and Abilities:
• Experience in Downstream/Purification, including Protein Chromatography, TFF, Depth Filtration, Viral Filtration, Bulk Drug Substance Formulation, and Final Filtration; familiarity with aseptic sampling, buffer preparation, tubing assemblies, and autoclaving operations.
• Knowledge of UNICORN and Common Control Platform (CCP) Software is preferred.
• Fundamental understanding of current biologics regulations and cGMP for drug substance operations.
• Proficiency with Microsoft Word and Excel.
• Ability to work with pressurized systems, steam, and corrosive chemicals with necessary safety precautions.
• Demonstrated capability to follow and document activities in written procedures and/or logbooks.
• Strong attention to detail, effective collaboration skills, and a proven team player.