Technician - Biomanufacturing, Downstream/mRNA

Catalent Pharma Solutions; United States; On-site; USD 42,000 - 64,000; Full time

Benefits offered by this job

Sign-on bonus $5,000

PTO and holidays

401K match

Medical, dental and vision benefits

Tuition Reimbursement

Job summary

Catalent, Inc. in Madison, WI is seeking an entry-level Technician - Biomanufacturing, Downstream/mRNA for 100% on-site night shift (10pm-8am). The role involves performing downstream purification and IVT-related activities, following cGMPs, and documenting work in GDP-friendly records.

It offers a $5,000 sign-on bonus and growth into a broader biomanufacturing program. The candidate will use software like TrackWise and DeltaV, work in a cleanroom, and may mentor new colleagues while

Qualifications

• Must have High School Diploma or equivalent plus at least two years of relevant experience.
• Bachelor's or Associate Degree in a scientific, engineering, or biomanufacturing discipline accepted without formal experience.
• GMP manufacturing experience preferred.
• Ability to use Microsoft Word and Excel and other Office systems.
• Preferred experience with TrackWise, ComplianceWire, JD Edwards, DeltaV, Chromatography software.

Responsibilities

• Perform basic Downstream purification and mRNA production activities, such as IVT reactions, chromatography, tangential flow filtration, viral filtration, and column packing.
• Accurately follow Batch Production Records and SOPs in accordance with cGMPs with focus on right first time.
• Document all activities in GDP-compliant records and forms.
• Recognize deviations and raise awareness through Rapid Response process.
• Identify safety, quality, and efficiency improvements; participate in Catalent Way CI.
• Possibly lead CI activities and mentor junior team members as onboarding buddy.
• Perform general cleanroom housekeeping and 5S maintenance.

Education

High School Diploma or equivalent

Bachelor's or Associate Degree in a scientific, engineering, or biomanufacturing discipline

Tools

Microsoft Word

Microsoft Excel

TrackWise

ComplianceWire

JD Edwards

DeltaV

Chromatography software

Job description

Technician - Biomanufacturing, Downstream/mRNA

$5,000 SIGN-ON BONUS

Position Summary: Work Schedule: 10pm-8am (Sunday-Wednesday or Wednesday–Saturday shift availability) 100% on-site

Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO). Located in Madison, WI, this facility features advanced mammalian cell line engineering and biomanufacturing capabilities using single-use systems to support scalable production. This 263,000 sq. ft. Good Manufacturing Practice (GMP) facility offers integrated formulation and analytical services to address complex development challenges in Biologics. This is an entry level position in the Manufacturing team and is the starting point to acquiring skills and training required for a cGMP biomanufacturing environment. The Technician is responsible for the manufacture of biopharmaceutical products within a clean room environment. The position is expected to follow detailed instructions and established procedures with frequent supervision.

Role

• Perform basic Downstream purification and mRNA production activities, such as in-vitro transcription (IVT) reactions, chromatography, tangential flow filtration (TFF), viral filtration, and column packing and qualification
• Accurately follows manufacturing Batch Production Records (BPRs) and Standard Operating Procedures (SOPs) in accordance with current Good Manufacturing Practices (cGMPs) and with a focus on “right first time” execution
• Documents all activities in accordance with Good Documentation Practices (GDPs) in BPRs, Forms, and other quality documentation
• Recognizes deviations from the intended procedure and raises awareness through the Rapid Response process
• Proactively identifies safety, quality, and efficiency improvements; Actively participates in the Catalent Way (Continuous Improvement Culture)
• May lead “Just Do It” (JDI) Continuous Improvement (CI) activities and engage in implementation of CI projects
• May coach more junior team members on basic execution activities and act as an “onboarding buddy” to facilitate bringing new team members quickly up to speed on culture and basic workplace expectations
• Performs general cleanroom housekeeping, including room and equipment cleaning, disposal of waste, and maintenance of 5S standards
• Other duties as assigned

Candidate

• Must have High School Diploma or equivalent plus at least two (2) years of relevant experience.
• We will also accept a Bachelors or Associates Degree in a scientific, engineering, or biomanufacturing discipline without any formal experience.
• GMP manufacturing experience preferred.
• Ability to use Microsoft Word and Excel, and other Office systems.
• Preferred experience with TrackWise, ComplianceWire, JD Edwards, DeltaV, Chromatography software.

Physical requirements

This position requires frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with EHS responsibilities for the position. Working conditions will be Heating Ventilation and Air Conditioned controlled. Ability to operate within a clean room environment as needed.

Why you should join Catalent

Defined career path and annual performance review and feedback process. Diverse, inclusive culture. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.

Benefits

• 152 hours of PTO + 8 paid holidays
• Generous 401K match
• Medical, dental and vision benefits
• Tuition Reimbursement - Let us help you finish your degree or start a new degree!

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [e-mail]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Visit Catalent Careers to explore career opportunities.