Be Part Of A High-Performing Team

Join a growing biopharmaceutical manufacturing organization focused on developing therapies for patients with serious and rare diseases. This Technical Operations team supports the manufacture and scale-up of advanced gene therapy products, with an emphasis on quality, scientific rigor, collaboration, and patient impact. The environment brings together process development, manufacturing, quality, and technical operations professionals working to reliably translate complex biologic processes into scalable manufacturing operations.

What's In Store For You

• Engagement: W2 only (no C2C/1099)
• Full-time, 40-hour-per-week contract opportunity.
• Work directly within a pilot-scale gene therapy manufacturing environment.
• Gain exposure to downstream purification, scale-up, manufacturing investigations, technology transfer, and continuous improvement activities.
• Collaborate with cross-functional manufacturing, process development, and quality teams.

How You Will Make An Impact

• Execute downstream purification processes at pilot and production scale, including chromatography, ultrafiltration, tangential flow filtration, and depth filtration.
• Operate and maintain chromatography systems, ultracentrifuges, TFF systems, and other standard bioprocessing equipment.
• Maintain rigorous compliance with cGMP and Good Documentation Practices throughout manufacturing activities.
• Prepare, review, and maintain batch records, SOPs, logbooks, technical reports, technology transfer documentation, and manufacturing records.
• Support manufacturing investigations, process troubleshooting, root-cause analysis, and resolution of production issues.
• Provide downstream process subject matter expertise during on-floor manufacturing activities and take ownership of assigned deliverables.
• Support scale-up activities and ensure processes are executed according to established procedures and manufacturing best practices.
• Participate in change controls and continuous improvement initiatives designed to improve process robustness, reliability, and efficiency.
• Maintain inspection readiness and support compliance with quality systems, training requirements, and facility procedures.

Do You Bring Proven Success in Downstream Bioprocessing and Purification?

• Bachelor's degree in Biology, Biotechnology, Biochemistry, or a related scientific discipline.
• Approximately 4–6 years of relevant process development or bioprocessing experience.
• Hands-on manufacturing or process development experience supporting biologics or advanced therapy production.
• Demonstrated experience with chromatography, ultrafiltration/TFF, and depth filtration in a laboratory, pilot plant, or production-scale environment.
• Working knowledge of cGMP and Good Documentation Practices.
• Experience preparing or maintaining controlled manufacturing documentation such as batch records, SOPs, logbooks, and technical reports.
• Experience supporting manufacturing investigations in biologics production is strongly preferred.
• Familiarity with Quality Management Systems and ERP platforms.
• Strong technical writing, troubleshooting, communication, and cross-functional collaboration skills.
• Ability to work effectively in a hands-on manufacturing environment while maintaining safety, quality, and regulatory standards.