Position Overview:
Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent?s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Yourtalents,ideasandpassionare essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here
This position will report directly to the Group Leader, Project Director.
Overview
Due to expansion, Catalent is looking to recruit an experienced Senior Associate Scientist ? Data Reviewer to join a growing analytical stability team at our site in Morrisville, NC. The analytical stability team at Catalent Morrisville is responsible for performing commercial, clinical and pre-commercial stability studies. Testing includes purity and potency by HPLC, dissolution testing (immediate and extended release products) and physical attributes (water, appearance, etc.). This position will support the laboratory as a technical data reviewer and report directly to the Group Leader.
The Research Triangle Park (RTP) facility is Catalent's Center of Excellence for Analytical Services and is also home to Catalent's Inhalation franchise including product development, clinical and commercial manufacturing for pMDI, DPI and Nasal Sprays.
The Role
Perform technical review of laboratory documentation (paper and electronic) for accuracy, completeness and regulatory compliance.
Laboratory rotation would be expected for training purposes.
The Candidate
Bachelor?s degree with 3-5 years related experience or an Associate?s degree with at least 5-7 years related experience
Experience reviewing GMP laboratory documentation
Experience with Empower, Excel
Experience with HPLC, dissolution and Karl Fischer testing.
Ability to interpret a variety of test methods, protocols and SOPs
Position Benefits
Potential for career growth within an expanding department as well as other areas
Medical, Dental, Vision and 401K are all offered from day one of employment
19 days of paid time off annually + 8 paid holidays
Leadership Competencies for Performance and Development
Leads with Integrity and Respect
Delivers Results
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
Champions Change
Engages and Inspires
Coaches and Develops
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 www.catalent.com/careers to explore career opportunities.
C atalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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 ********** . 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.
