Technician for Upstream Biomanufacturing Operations

2 weeks ago

Madison, Wisconsin, United States Catalent Full time

Position Overview: Technician - Biomanufacturing, Upstream

Catalent is a prominent, rapidly expanding public enterprise 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 accelerating the availability of superior biologic therapies for patients. This division encompasses our proprietary GPEx cell line engineering platform, our advanced biomanufacturing facility, and our leading biologics analytical services, alongside SMARTag Antibody Drug Conjugate technology. By leveraging our expanding portfolio of differentiated technologies, exceptional manufacturing capabilities, and integrated services throughout the Catalent network, Catalent Biologics is well-positioned for substantial growth.

The Manufacturing department is tasked with executing clinical and commercial production in alignment with regulatory standards, site protocols, and client specifications. Our cGMP production activities include solution preparation, master and working cell bank production, upstream cell culture, downstream protein purification, mRNA and molecular therapeutics production, as well as small-scale fill and finish operations. Additionally, manufacturing operations are committed to employing continuous improvement methodologies to achieve process optimization, enhance efficiency, and minimize waste, thereby maximizing output capacity.

This role serves as an entry-level opportunity within the Manufacturing team, acting as a foundational step towards acquiring the skills and training necessary for a cGMP biomanufacturing environment. The Technician will be responsible for the production of biopharmaceutical products within a controlled cleanroom setting. The position requires adherence to detailed instructions and established protocols under regular supervision.

Key Responsibilities:

  • Conduct basic upstream cell culture tasks, including aseptic manipulation of cell cultures in 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), emphasizing accurate execution.
  • Document all activities in accordance with Good Documentation Practices (GDPs) in BPRs, forms, and other quality records.
  • Identify deviations from established procedures and escalate concerns through the Rapid Response process.
  • Actively seek opportunities for safety, quality, and efficiency enhancements; participate in the Catalent Way (Continuous Improvement Culture).
  • Potentially lead "Just Do It" (JDI) Continuous Improvement initiatives and engage in the implementation of CI projects.
  • May mentor junior team members on fundamental execution tasks and serve as an onboarding buddy to assist new team members in acclimating to the culture and basic workplace expectations.
  • Participate in daily shift meetings and may lead shift handover activities.
  • Perform general cleanroom maintenance, including cleaning of rooms and equipment, waste disposal, and adherence to 5S standards.
  • Undertake additional responsibilities as assigned.

Candidate Qualifications:

  • Bachelor’s or Associate’s Degree in a scientific, engineering, or biomanufacturing field with no prior experience required OR
  • High School Diploma with a minimum of 2 years of relevant experience.
  • GMP experience is preferred.
  • The individual may be required to lift and/or move 0-10 pounds frequently, and occasionally lift and/or move up to 50 pounds.

Why Join Catalent?

  • Clearly defined career progression and an annual performance review process.
  • A diverse and inclusive workplace culture.
  • Opportunities for career advancement within a growing team dedicated 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 effective from the first day of employment.
  • Tuition reimbursement programs.

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

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

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

If you require reasonable accommodation for any part of the application or hiring process due to a disability, please submit your request to ensure appropriate consideration.

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