Downstream Manufacturing Associate III - TFF & AKTA Chromatography | GMP Biologics
Job Description
Title: Downstream Manufacturing Associate III – TFF & AKTA Chromatography | GMP Biologics
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Location: Greater Milford Area, MA (Onsite)
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Employment Type: Contract
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Status: Accepting Candidates
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Shift: 3rd Shift
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Hours: This position will follow an Overnight 4/3 schedule, 6pm-6:30am, Wed-Sat (working every other Wednesday).
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About the role
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Support GMP downstream manufacturing activities for biologics, with a focus on TFF, AKTA chromatography, and MAb purification. The role operates within a clinical manufacturing environment and requires strong troubleshooting, documentation, and cross-functional collaboration.
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Key Responsibilities
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- Perform downstream manufacturing operations involving TFF, chromatography, and purification.
- Operate and troubleshoot AKTA Ready, AKTA Process, and XDUOS buffer systems.
- Monitor batch parameters and complete documentation following GDP/GMP requirements.
- Troubleshoot process issues, respond to alarms, and support event investigations.
- Train newer operators and serve as a subject matter expert on production equipment.
- Support continuous improvement activities and cross-functional manufacturing teams.
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Qualifications
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- 4+ years of related experience with a Bachelor’s degree, or 6+ years with a high school diploma.
- Demonstrated experience in cGMP manufacturing, preferably downstream biologics manufacturing.
- Hands-on experience with TFF, chromatography systems, and MAb purification.
- Knowledge of AKTA systems, single-use/disposable technology, process tanks, and chromatography skids/columns.
- Strong troubleshooting, GMP documentation, and technical writing skills.
- Ability to work in a cleanroom environment and support an overnight 4/3 schedule.
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Compensation (MA Pay Transparency):
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- Estimated hourly range: $38–$44/hr (W-2) + 20% overnight differential.
- Final rate within this range will be based on skills, experience, and interview results.
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