Technician- Biomanufacturing, Upstream

Catalent; Madison (WI); On-site; USD 52,000 - 64,000; Full time

Benefits offered by this job

152 hours PTO + 8 paid holidays

401K match

Medical, dental and vision benefits

Tuition Reimbursement

Job summary

Catalent, Inc. in Madison, WI, seeks an entry level Technician - Biomanufacturing, Upstream to support biopharmaceutical production in a Grade A cleanroom.

You will perform basic upstream cell culture activities, follow BPRs and SOPs, document activity in GDP-compliant records, and contribute to continuous improvement while developing skills for a cGMP manufacturing environment. Strong attention to safety and quality, willingness to learn, and ability to work with supervision are essential for

Qualifications

• High School Diploma or equivalent with at least 2 years of relevant experience, or a Bachelor's/Associate degree in a scientific/engineering/biomanufacturing discipline.
• GMP manufacturing experience is preferred.
• Proficiency with MS Word/Excel and other Office tools.
• Experience with track-and-trace quality systems is a plus.

Responsibilities

• Perform basic Upstream cell culture activities in a Grade A environment, including aseptic manipulation and large-scale culture in single-use bioreactors.
• Follow Batch Production Records (BPRs) and SOPs to ensure cGMP compliance and right first time execution.
• Document all activities according to GDP and quality records; maintain accurate and complete records.
• Identify deviations and escalate through Rapid Response processes.
• Contribute to Continuous Improvement initiatives and participate in CI projects.
• May coach junior team members and assist onboarding of new staff.
• Perform general cleanroom housekeeping and 5S standards; ensure equipment and room maintenance.
• Perform other duties as assigned.

Skills

MS Word & Excel

Attention to detail

GMP manufacturing experience

Education

High School Diploma or equivalent

Bachelor's or Associate's Degree in scientific/engineering/biomanufacturing

Tools

TrackWise

ComplianceWire

JD Edwards

DeltaV

Chromatography software

Job description

Technician - Biomanufacturing, Upstream

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.

The Role

• Perform basic Upstream cell culture activities, such as aseptic manipulation of cell culture within a Grade A environment, large-scale cell culture within single-use bioreactors (SUBs), and clarification of bulk harvest product
• 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

The 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
• GMP manufacturing experience preferred
• 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
• 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].

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.

Massachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.