Biomanufacturing Associate, Downstream/mRNA - Evening Shift

Catalent Pharma Solutions; Madison, Northern (WI, KY); Hybrid; USD 68,000 - 86,000; Full time

Benefits offered by this job

152 hours PTO + 8 holidays

Generous 401K match

Medical, dental, vision benefits

Tuition Reimbursement

Job summary

Catalent Pharma Solutions in Madison, WI is hiring an Associate for Biomanufacturing (Downstream/mRNA). The role focuses on downstream purification and IVT workflows in a cleanroom, operating 2pm–12am on-site shifts, with documentation in BPRs and GDP-compliant records.

You will follow cGMP, perform deviations reporting, and participate in CI activities. Qualifications include a HS diploma with 4+ years of experience or a STEM degree with relevant experience.

Qualifications

• Must have High School Diploma or equivalent plus at least four years of relevant experience.
• Bachelor’s/Associate in science or engineering with 1+ year experience accepted; Master’s in STEM welcome.
• GMP manufacturing experience preferred; proficient with Word/Excel; familiarity with TrackWise, ComplianceWire, JD Edwards, DeltaV, Unicorn.

Responsibilities

• Perform downstream purification for mRNA production activities (IVT, chromatography, TFF, viral filtration, fill, column packing).
• Follow Batch Production Records (BPRs) and SOPs per cGMP with right‑first‑time execution.
• Document activities with GDP in BPRs and forms; recognize deviations and raise through Rapid Response.
• Lead CI activities and participate in Catalent Way; may coach junior teammates and onboard new staff.
• Interact with clients during PIP observations and provide batch status updates; participate in shift huddles.
• Maintain cleanroom housekeeping and 5S standards; other duties as assigned.

Skills

GMP manufacturing experience

Attention to detail

Microsoft Word & Excel

Cleanroom procedures

Education

High School Diploma or equivalent

Bachelor’s or Associate in science/engineering/biomanufacturing with 1+ year experience

Master’s in STEM (no experience required)

Tools

TrackWise

ComplianceWire

JD Edwards

DeltaV

Unicorn Chromatography

Job description

Catalent Pharma Solutions in Madison, WI is hiring an Associate for Biomanufacturing (Downstream/mRNA). The role focuses on downstream purification and IVT workflows in a cleanroom, operating 2pm–12am on-site shifts, with documentation in BPRs and GDP-compliant records.

You will follow cGMP, perform deviations reporting, and participate in CI activities. Qualifications include a HS diploma with 4+ years of experience or a STEM degree with relevant experience.