Senior Manufacturing Associate, Downstream

Senior Manufacturing Associate, Downstream

Join to apply for the Senior Manufacturing Associate, Downstream role at Tanvex CDMO is Now Bora Biologics
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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 will be performed according to SOPs and batch records. The position involves performing manufacturing steps, executing routine batch records, revising documents such as batch records and SOPs as needed, driving projects and assignments, and providing mentorship to associates.

A flexible shift schedule and overtime may be required.

• Perform moderately complex tasks using defined protocols or procedures to achieve project milestones.
• Perform GMP manufacturing activities in assigned areas.
• Set‑up, operate, maintain and clean downstream bioprocessing equipment, including chromatography systems, UF/DF and viral filtration skids, mixers, and related equipment.
• Perform basic troubleshooting of bioprocess equipment.
• Perform manual cleaning and sterilization of manufacturing areas, parts and components.

• Follow SOPs, cGMPs, plant safety guidelines and other procedures to produce quality products.
• Maintain detailed process‑related documentation of equipment logs and batch records following GDP.
• Draft and revise SOPs and batch records.

• Participate in scheduled team meetings for troubleshooting, lessons learned and project planning.
• Provide mentoring and coaching to colleagues with similar or less experience.
• Act as lead when specialist/supervisor is unavailable.
• Address production issues and report compliance concerns promptly.
• Foster teamwork and suggest project improvements.

• Advanced degree in life sciences or related discipline with 3 years of experience in pharma/biotech, or equivalent.
• Bachelor’s degree with 6 years of experience, or equivalent.
• High School Diploma/GED with 8 years of experience, or equivalent.

• Downstream/purification experience: protein chromatography, TFF, depth filtration, viral filtration, bulk drug substance formulation, final filtration; aseptic sampling; buffer preparation, tubing assemblies, autoclaving operations.
• Preferred knowledge of UNICORN and Common Control Platform (CCP) Software.
• Fundamental knowledge of cGMP and current biologics regulations.
• Proficient with Microsoft Word and Excel.
• Ability to work with pressurized systems, steam and corrosive chemicals with necessary safety precautions.
• Demonstrated ability to follow and document activities in written procedures and logbooks.
• Detail‑oriented, strong team player with effective collaboration across categories and stakeholders.

$75,443 - $90,532

Seniority level:
Mid‑Senior Level

Employment type:

Full‑time
Job function:
Research, Analyst, and Information Technology
Industries:
Pharmaceutical Manufacturing

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