Associate I - Biomanufacturing, Downstream

Position Summary:

Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services in Kansas City, MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.

The Manufacturing 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, upstream 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 is a full- time, hourly, position: Sunday – Wednesday, 10:00 pm – 8:00 am

The Associate I – Biomanufacturing, Downstream position is an entry level position in the Downstream Manufacturing team and is the starting point to acquiring skills and training required for a cGMP biomanufacturing environment. The Associate II is responsible for the manufacturing of biopharmaceutical products through the use of general analytical equipment and liquid handling equipment including pH and conductivity meters, biophotometers, single-use mixing tanks, tube fusers, and tube sealers. This role is also responsible for the use and maintenance of single-use chromatography and filtration skids, as well as large scale chromatography column packing.

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:

• Follows detailed procedures to purify, concentrate, and bulk fill drug substance.
• Performs aseptic techniques within in a clean room environment.
• Operates single-use biomanufacturing processing skids, including but not limited to, chromatography and normal flow filtration.
• Uses basic biomanufacturing equipment such as tube fusers, tube sealers, pumps, balances, pH meters, biophotometers, mix tanks and other applicable manufacturing equipment.
• Performs packing and unpacking of large-scale chromatography columns.
• Performs final storage freezing of product as required.
• Executes and documents with proper completion of Standard Operating Procedures (SOP), Batch Production Records (BPR) and Job Aid (JA).
• Other duties as assigned.

The Candidate:.

• Bachelors or Associates 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.
• Ability to use Excel, Word, and other office systems
• Ability to learn and use quality, operations and/or scientific management software such as TrackWise®, ComplianceWire®, JD Edwards®, DeltaV®, Chromatography (i.e. Unicorn®), etc
• Ability to gain a basic understanding of pharmaceutical laboratory and/or production operations.
• Supports deviation investigations and corrective / preventative actions.
• Must comply with EHS responsibilities for the position.

Catalent Benefits:

• 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 paid time off annually + 8 paid holidays
• Competitive salary with yearly bonus potential
• Community engagement and green initiatives
• Generous 401K match and Paid Time Off accrual
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement
• On-site fitness center and wellness programs

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 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.