Upstream Biomanufacturing Specialist

2 weeks ago

Madison, Wisconsin, United States Catalent Full time

Position Overview: Technician - Biomanufacturing, Upstream

Catalent is a prominent, rapidly expanding public entity and a key collaborator for the pharmaceutical sector in the creation and production of innovative therapies for patients globally. Your skills, creativity, and enthusiasm are vital to our mission: to enhance the quality of life for individuals.

Catalent Biologics represents a dynamic segment within Catalent Pharma Solutions, dedicated to delivering cutting-edge technologies and solutions aimed at facilitating the timely delivery of biologic therapies to patients. This division encompasses our proprietary GPEx cell line engineering platform, our advanced biomanufacturing facility, and our leading analytical services for biologics, alongside SMARTag Antibody Drug Conjugate technology. By leveraging our diverse technology portfolio and world-class manufacturing capabilities, Catalent Biologics is poised for substantial growth.

The Manufacturing department oversees the execution of clinical and commercial production in alignment with regulatory, site, and client standards. Our cGMP production activities involve solution preparation, master and working cell bank production, upstream cell culture, downstream protein purification, mRNA and molecular therapeutics production, and small-scale fill/finish operations. Furthermore, the manufacturing team is committed to applying continuous improvement strategies to enhance process efficiency, optimize outputs, and minimize waste.

This role serves as an entry-level opportunity within the Manufacturing team, providing a foundation for acquiring the necessary skills and training for a cGMP biomanufacturing setting. The Technician will be responsible for producing biopharmaceutical products in a controlled cleanroom environment, adhering to detailed instructions and established protocols under close supervision.

Key Responsibilities:

  • Conduct basic upstream cell culture tasks, including aseptic manipulation within a Grade A environment, large-scale cell culture in single-use bioreactors, and clarification of bulk harvest products.
  • Diligently follow manufacturing Batch Production Records (BPRs) and Standard Operating Procedures (SOPs) in compliance with current Good Manufacturing Practices (cGMPs), ensuring accurate execution.
  • Maintain comprehensive documentation of all activities in accordance with Good Documentation Practices (GDPs) in BPRs, forms, and other quality records.
  • Identify deviations from established procedures and promptly report them through the Rapid Response process.
  • Actively seek opportunities for safety, quality, and efficiency enhancements; engage in the Catalent Way (Continuous Improvement Culture).
  • Potentially lead "Just Do It" (JDI) Continuous Improvement initiatives and contribute to the implementation of CI projects.
  • May mentor junior team members on fundamental execution tasks and serve as an onboarding buddy to assist new hires in acclimating to workplace culture and expectations.
  • Participate in daily shift meetings and may facilitate shift handover activities.
  • Perform general cleanroom maintenance, including cleaning of rooms and equipment, waste disposal, and upholding 5S standards.
  • Undertake additional duties as assigned.

Candidate Qualifications:

  • A Bachelor’s or Associate’s Degree in a scientific, engineering, or biomanufacturing field is required, with no prior experience necessary OR
  • A High School Diploma with at least 2 years of relevant experience.
  • Experience in GMP environments is preferred.
  • Ability to lift and/or move 0-10 pounds frequently, with occasional lifting/moving of up to 50 pounds.

Why Join Catalent?

  • Clearly defined career progression and annual performance evaluations.
  • A diverse and inclusive workplace culture.
  • Opportunities for career advancement within a growing organization committed to improving lives.
  • 152 hours of paid time off annually, plus 8 paid holidays.
  • Competitive salary with potential for annual bonuses.
  • Community involvement and sustainability initiatives.
  • Generous 401K matching and Paid Time Off accrual.
  • Comprehensive medical, dental, and vision benefits from day one of employment.
  • Tuition reimbursement programs.

Catalent provides rewarding career opportunities. Join the leader in drug development and delivery and contribute to bringing over 7,000 life-saving and life-enhancing products to patients worldwide. Catalent is an exciting and expanding international organization where employees collaborate with pharmaceutical, biopharmaceutical, and consumer health companies of all sizes to advance new therapies from early development through clinical trials to market. Catalent produces over 70 billion doses annually, each one relied upon by someone in need. Join us in making a meaningful impact.

Catalent is dedicated to the health and safety of its employees, visitors, and the patients we serve. In response to the global pandemic, we have adapted our recruitment and onboarding processes to ensure everyone's safety. The Human Resources team will communicate all necessary safety protocols throughout each stage of the process.

Catalent is an Equal Opportunity Employer, including individuals with disabilities and veterans.

Important Security Notice: Catalent NEVER requests candidates to provide any form of payment, bank details, identification photocopies, social security numbers, or other sensitive personal information during the hiring process. If you receive such a request, do not respond; it is fraudulent. Please report such requests for investigation.

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