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Associate Scientist II, Quality Control
Fri-Sun 6am-6pm
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.
Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast-growing business, backed by a global public company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent 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.
The Associate Scientist II, Quality Control requires a variety of skills necessary for biotech company operations. The position is an entry level laboratory role with the expectation that the candidate is able to be trained on technical procedures and once trained, execute them consistently and reliably. Additionally, this position may support preventative maintenance and basic laboratory maintenance activities while maintaining a GMP quality system.
Analytical testing, data analysis, document writing, and data reporting to support the manufacturing and release of bulk drug substance and drug product.
This is a full-time on-site position, Fri-Sun 6am-6pm
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:
• Executes and properly documents cGMP Quality Control testing with minimal supervision.
• Independently operates basic cGMP Quality Control equipment and moderately complex cGMP Quality Control equipment with supervision.
• Performs self-review of analytical data for accuracy and consistency with SOP.
• Enters data into Laboratory Information Management System (LIMS) or laboratory reports.
• Performs general lab housekeeping in adherence to 5S standards.
• Initiates records in TrackWise.
• Accurately completes routine and preventive maintenance on basic to moderately complex equipment.
• Actively participates in team meetings and/or training sessions.
• Other duties as assigned
The Candidate:
• Bachelor’s Degree in Biology, Biotechnology, Chemistry, or related life sciences field with a minimum of 1 year of industry experience.
• Associate Degree in Biology, Biotechnology, Chemistry, or related life sciences field with a minimum of 4 years of industry experience.
• High School Diploma or equivalent with a minimum of 6 years of industry experience.
• Preferred:
• Basic understanding of analytical chemistry and simple lab equipment.
• Familiarity with clean room procedure, aseptic technique, and general lab equipment experience.
• cGMP, Good Documentation Practices (GDP), or Good Laboratory Practices (GLP) knowledge.
• Experience following standard operating procedures (SOP).
• General laboratory equipment experience, including micropipettes
Position 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
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.
