ASSISTANT, CGMP BIOMANUFACTURING SOLUTIONS PREP (WED-SAT 6AM-4PM)

POSITION SUMMARY:

The Manufacturing department is responsible for the execution of clinical and commercial manufacturing in accordance with regulatory, site, and client requirements.

Manufacturing 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. The Manufacturing team executes batch production records and SOPs in a cGMP environment, focusing on 'right first time' and on-time delivery.

The Solution Prep team works within the manufacturing cleanroom space and prepares all solutions used by the manufacturing execution team(s). The Technician 1 is an entry level position that provides an opportunity to gain valuable cGMP and cleanroom production experience. The Technician I is responsible for ensuring all equipment is ready for operations and that the materials needed are stocked appropriately to support solution preparation. The Technician 1 also performs general cleanroom housekeeping ensuring the lab is organized and meets all Environmental Health and Safety (EHS) expectations.

THIS IS A FULL-TIME, HOURLY POSITION. WEDNESDAY - SATURDAY 6:00AM - 4:00PM.

Our new, state of the art Madison, WI facility, with expanded mammalian cell line engineering and biomanufacturing capabilities utilizing single-use systems, offers increased flexibility and manufacturing scale to support our customers' growth. We offer a broad range of integrated formulation and analytical services to solve your most difficult development challenges in Biologics.

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.

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:

• Performs daily calibrations of equipment needed to support solution preparation such as pH meters, balances, and other equipment requiring daily calibrations.

• Supports solution preparation activities by picking and prepping materials, documenting use of materials in the batch production record, setting up the storage bags, and other various support functions.

• Organizes and prepares the room for the next shift.

• Performs general cleanroom housekeeping, including room and equipment cleaning(s), disposal of trash and recyclables, and adherence to 5S standards.

• Performs the EHS room inspection of the formulation lab.

• Performs logbook reviews as directed by the SOP.

• Executes other duties as assigned.

THE CANDIDATE:

• High School Diploma, or equivalent, with no experience required

• GMP experience preferred.

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 +8paid 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.

Catalent is a global leader in providing integrated services, superior drug delivery technologies and manufacturing solutions to help life science innovators develop and launch successful pharmaceuticals, biologics and consumer health products. We have built an advanced range of technologies and capabilities and are dedicated to enabling a better and faster customer journey from product development directly to patient. At Catalent, we share a common goal, to put patients first and help people around the world live better and healthier lives.