Stability Analyst I

The Stability Analyst I position under general supervision, performs work that is varied and that may be somewhat difficult in character, but usually involves limited responsibility. Some evaluation, originality or ingenuity is required. Follows established protocols and work plans. May be assisted by laboratory technicians/assistants. Comply with divisional and site Environmental Health and Safety requirements.

Catalent Cell & Gene Therapy hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives.

The role:

• Execute laboratory work plan / schedule developed with input from supervisor or senior team member
• May draft technical documents such as methods or certificates of analysis
• Performs parallel review of laboratory documentation and may become qualified to perform technical review of documents for accuracy, thoroughness and regulatory compliance
• Trains others on laboratory techniques
• Assists in the execution of efficiency improvement project with guidance 5 6. All other duties as assigned

The candidate:

• Master's degree and 0 years related experience
• Bachelor's degree and up to 3 years related experience
• Associate's degree and up to 6 years related experience or equivalent education, experience, and training
• Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs
• Basic understanding of instrument operations and troubleshooting skills in multiple techniques
• All employees must receive training on the fundamental principles of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), Data Integrity, and employee conduct as a condition for performing GxP activities.
• All employees performing GxP activities must be trained

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 [email protected]. 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 [email protected] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.