Downstream Purification Specialist - Overnight

Rentschler Biopharma, Inc.; Milford (MA); On-site; USD 49,593 - 63,369; Full time

Job summary

Rentschler Biopharma, Inc. in Milford, MA seeks a Downstream Manufacturing Associate III to support biologics purification on an overnight Wed-Sat schedule.

You will operate downstream processes, including TFF and chromatography, under cGMP and GDP guidelines while training teammates and contributing to batch documentation. The role demands strong problem-solving, cross-functional collaboration, and the ability to work in a cleanroom environment.

Qualifications

• Demonstrated knowledge of cGMP downstream manufacturing.
• Experience with TFF, chromatography systems and Mab purification.
• Able to write deviations and revise batch records.
• Strong troubleshooting and cross-functional collaboration skills.
• Ability to train operators and lead process improvements.

Responsibilities

• Perform downstream manufacturing operations and purification steps as applicable.
• Monitor batch parameters and record data per GDP/GMP guidelines.
• Initiate new documents and revise procedures as needed.
• Troubleshoot process problems and respond to alarms promptly.
• Oversee training of new employees and track required certifications.
• Coordinate with support teams for inventory and event investigations.
• Lead continuous improvement activities (5S, Gemba, OMT).
• Ensure cleanroom hygiene and PPE compliance during operations.

Skills

GMP downstream manufacturing

TFF

Chromatography systems

Purification of Mabs

Troubleshooting equipment

Training others

Process documentation

Education

6+ years experience with high school diploma

Bachelor's degree + 4+ years experience

Biotech certificate (preferred)

Tools

Akta Ready

Akta Process

XDUoS buffers

Disposable technology

Job description

Rentschler Biopharma, Inc. in Milford, MA seeks a Downstream Manufacturing Associate III to support biologics purification on an overnight Wed-Sat schedule.

You will operate downstream processes, including TFF and chromatography, under cGMP and GDP guidelines while training teammates and contributing to batch documentation. The role demands strong problem-solving, cross-functional collaboration, and the ability to work in a cleanroom environment.