Downstream Manufacturing Associate III - 3rd Shift

Title: Downstream Manufacturing Associate III

Location: Milford, MA (Onsite, 3rd Shift)

Employment Type: Contract, 6+ Months

Status: Accepting Candidates

About the Role

Support GMP downstream manufacturing operations for clinical, development, validation, and commercial-scale activities, serving as a technical resource for purification processes, equipment operation, troubleshooting, and team training.

Key Responsibilities

• Execute downstream manufacturing operations involving tangential flow filtration (TFF), chromatography, monoclonal antibody (mAb) purification, and disposable technologies.
• Operate and troubleshoot manufacturing equipment and systems, including ÄKTA systems, XDUO buffer systems, process tanks, chromatography skids and columns, and related production equipment.
• Monitor and document batch parameters, complete GMP/GDP documentation, perform calculations, and support deviations, investigations, event management, and batch-record revisions.
• Train and oversee newer operators, serve as a subject matter expert, and support cross-functional teams and manufacturing stakeholders.
• Lead or contribute to continuous improvement initiatives and process improvements while maintaining cleanroom, safety, and production requirements.

Qualifications

• High school diploma with 6+ years of related experience, an associate degree in Life Sciences/Engineering with relevant experience, or a bachelor's degree with 4+ years of related experience; biotech certification preferred.
• Demonstrated experience in cGMP downstream manufacturing, particularly TFF, chromatography, and mAb purification.
• Experience operating and troubleshooting laboratory and pharmaceutical production equipment and applying structured problem-solving/root-cause analysis.
• Strong technical documentation, communication, computer, and Microsoft Word/Excel skills, with the ability to author procedures and complete GMP records accurately.
• Ability to work effectively in a cleanroom environment, follow hygiene and PPE requirements, and work the required overnight schedule, including weekends, holidays, and overtime as needed.

Compensation:

• $35–$44/hr + 20% shift differential.
• Final compensation within the posted range will depend on qualifications, experience, and interview results.