Biomanufacturing Technician

4 weeks ago

Madison, United States Catalent Pharma Solutions Full time

**Position**:BioManufacturing Technician, Downstream / mRNA
**Shift**:WED to SAT, 10:00pm to 8:00am (15% shift differential for 3rd Shift)
**Location**:Madison, Wisconsin

Catalent is a global leading drug development and biomanufacturing organization, partnering with more than 1,000 biotech and pharmaceutical clientele to deliver 8,000+ FDA approved products annually. Catalent has over 50 locations worldwide, and our center-of-excellence for cell line development and mammalian cell culturing is based at our Madison, Wisconsin biologics facility. This location includes our proprietary GPEx cell line engineering technology, critical to developing highly stable cells that will be fused with active pharmaceutical ingredients in lifesaving and life-enhancing treatment and medications.

The Downstream BioManufacturing department is responsible for the execution of clinical and commercial manufacturing in accordance with regulatory, site, and client requirements. Manufacturing cGMP production activities include solution preparation, master/working cell bank production, cell culture, downstream protein purification, mRNA and molecular therapeutics production, and small-scale fill/finish. Further, manufacturing operations is tasked to utilize continuous improvement methodologies to realize process optimization, efficiency gains, and waste reduction to maximize capacity outputs.

This position is an entry-level / junior position with rapid growth potential at one of Catalent’s fastest growing and most relevant sites

**The Role**:

- Performs 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 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
- Participates in daily shift huddles and may lead shift exchange activities
- Performs general cleanroom housekeeping, including room and equipment cleaning, disposal of waste, and maintenance of 5S standards
- Requires Bachelors or Associate Degree in a scientific, engineering or biomanufacturing discipline with no experience required **OR **High School Diploma with a minimum of 2 years of relevant experience
- GMP experience preferred
- Individual may be required to lift and/or move 0-10 pounds frequently, and occasionally moving and/or lifting up to 50 pounds

**Why you should join Catalent**:

- Defined career path and annual performance review and feedback process
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
- 52 hours of paid time off annually + 8 paid holidays
- Competitive salary with yearly bonus potential
- Community engagement and green initiatives
- 401K matching and tuition reimbursement initiatives
- Medical, dental, and vision benefits effective day one of employment

**Catalent offers rewarding opportunities to further your career** Join the global drug development and delivery leader and help us bring over 8,000 lifesaving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 80 billion doses per year, and each one will be used by someone who is counting on us.
- **Join us in making a difference**_

Pay: From $29.90 per hour

Expected hours: 40 per week

**Benefits**:

- 401(k) matching
- Dental insurance
- Employee discount
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Professional development assistance
- Referral program
- Tuition reimbursement
- Vision insurance

Schedule:

- 10 hour shift
- Night shift

Ability to Relocate:

- Madison, WI 53717: Relocate before starting work (required)

Work Location: In person

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