Job Information
Catalent Pharma Solutions Supervisor - Biomanufacturing, Downstream/mRNA in Madison, Wisconsin
We're hiring for a Supervisor – Biomanufacturing, Downstream/mRNA to support the Manufacturing Process Execution team in Madison, Wisconsin!
Catalent is a global, high-growth company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.
The Supervisor – Biomanufacturing, Downstream/mRNA is responsible for overseeing a team responsible for Downstream manufacturing of biologics drug substance and mRNA & Molecular Therapeutics, supporting direct execution and providing leadership oversight. This is a full-time, salaried position and is 100% site based. The schedule is Sunday - Wednesday, 6:00AM - 4:00PM.
Catalent’s Madison, Wisconsin site is a state-of-the-art biomanufacturing facility specializing in integrated formulation and analytical services. Our site features our proprietary Gene Expression Technology (GPEx) cell line engineering platform, and biomanufacturing capabilities utilizing single-use systems. Our employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart, and lung diseases as well as Alzheimer’s.
Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.
The Role
Supervises biomanufacturing activities in a clean room environment, ensuring execution is compliant with cGMPs and production deadlines are met.
Supervises operation of cGMP biomanufacturing equipment such as pH/conductivity meters, mixing tanks (SUMs), tubing fusers/sealers, filter integrity testers, peristaltic pumps, balances, and BioSafety Cabinets (BSC) or Laminar Flow Hoods (LFH).
Authors and revises Standard Operating Procedures (SOP), Batch Production Records (BPR) and Job Aids (JA).
Performs daily review and final sign-off of executed cGMP documentation (BPRs, forms).
Trains, monitors, and mentors direct reports on biomanufacturing activities.
Supervises completion of routine and preventive maintenance on biomanufacturing equipment.
Supervises/executes equipment qualification/validation protocols, as required.
Supports deviation investigations and change control/protocol execution in a time sensitive fashion.
Executes other duties as assigned.
The Candidate
Master’s Degree in a scientific, engineering or biomanufacturing discipline with a minimum of 2 year of related experience, or Bachelor’s or Associate's Degree in a scientific, engineering or biomanufacturing discipline with a minimum of 4 years of related experience, or High School Diploma with a minimum of 6 years of related experience. Demonstrated excellence in prior roles can be a substitute for the minimum years of experience.
GMP experience required.
Leadership experience preferred.
Downstream or upstream cGMP manufacturing experience preferred.
Excellent written and verbal communication skills with internal and external customers.
Strong organization with ability to handle and direct multiple activities within the group simultaneously.
Why you should join Catalent
Defined career path and annual performance review and feedback process.
Medical, dental and vision benefits are effective on the first day of employment.
Potential for career growth on an expanding team and organization.
152 hours of paid time off annually plus 8 paid holidays.
Community engagement and green initiatives.
Competitive salary with bonus potential.
Tuition reimbursement program.
Diverse, inclusive culture.
Generous 401K match.
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving 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 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers (https://careers.catalent.com/us/en) to explore career opportunities.
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 DisabilityAccommodations@catalent.com . 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.
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.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .
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