Senior Biomanufacturing Downstream Lead – mRNA

Catalent; Madison (WI); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

PTO 152 hours + 8 holidays

401K match

Medical, dental and vision benefits

Tuition reimbursement

Career growth opportunities

Job summary

Catalent, Inc. in Madison, WI, is seeking a Biomanufacturing Sr. Associate to provide process leadership in a 263,000 sq ft GMP facility.

The role involves moving biopharmaceutical products through downstream purification in a clean room, with emphasis on right-first-time execution and adherence to GDPs and BPRs. The candidate will mentor junior staff, potentially train others, and partner with clients during PIP observations while supporting continuous improvement initiatives and shift

Qualifications

• High School Diploma or equivalent with 7+ years relevant experience or a BA/AS with 3+ years, or a Master’s in STEM with 1+ year(s) of experience.
• GMP manufacturing experience is preferred.
• Proficiency with Microsoft Word and Excel and other Office tools; familiarity with listed software is a plus.

Responsibilities

• Troubleshoot and perform downstream purification for mRNA production activities (IVT, chromatography, TFF, viral filtration, filling, column packing).
• Follow Batch Production Records and SOPs per cGMP with a right-first-time focus.
• Document activities in GDP-compliant records and other quality docs.
• Identify deviations and drive safety, quality, and efficiency improvements.

Skills

Attention to detail

Problem-solving

Mentoring

Education

High School Diploma or equivalent

Bachelor's or Associate degree in science/engineering/biomanufacturing

Master’s in STEM

Tools

TrackWise

ComplianceWire

JD Edwards

DeltaV

Unicorn

Job description

Catalent, Inc. in Madison, WI, is seeking a Biomanufacturing Sr. Associate to provide process leadership in a 263,000 sq ft GMP facility.

The role involves moving biopharmaceutical products through downstream purification in a clean room, with emphasis on right-first-time execution and adherence to GDPs and BPRs. The candidate will mentor junior staff, potentially train others, and partner with clients during PIP observations while supporting continuous improvement initiatives and shift