Lead Scientist, QC Program Management

The Lead Quality Control Scientist will serve as the liaison between Quality Control (QC) and clients. The Lead QC Scientist will work with Project Management and clients to establish testing in the Quality Control lab, external contract testing laboratories and stability programs.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

The role:

• Attend client meetings to establish testing and stability protocols.
• Ensure completion of project team assigned QC related activities.
• Coordinate internal testing with Quality Control group.
• Coordinate product and raw material testing with external testing laboratories.
• Coordinate with the stability group and clients to establish stability studies.
• Review and approve client sampling plans.
• Review and approve batch records.  Ensure sample testing schedule is accurate.
• Develop and maintain QC client activities tracker.
• Communicate manufacturing and testing schedules to the Quality Control group.

The candidate:

• Bachelor’s degree in field relating to Biology, Chemistry, Engineering, Pharmacy, Information Technology or related discipline and 8 - 10 years of experience working in a QC (will consider reduced experience with increased levels of education in same field)
• Project Management and Contract Manufacturing experience necessary.
• Comprehensive and practical working knowledge of applicable GMP regulations, ICH guidelines, FDA guidelines, USP and EP, and other applicable regulatory guidances (US and EU).
• Strong focus on responsiveness, ability to multi-task, attention to detail, effective problem-solving skills, consistent follow-up and ability to make timely and sound decisions (Quality and Business).  Must be able to prioritize.
• Must possess excellent communication and writing skills, patience, professionalism and ability to effectively interact with staff and management alike (transversally collaborative) across functional groups and levels and with external clients.
• Ability to analyze information and solve problems relating to Quality Control.

The anticipated salary range for this position in Maryland is $118,720-$163,240 plus an annual bonus target. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.

Why you should join Catalent:

• Competitive medical benefits and 401K
• 152 hours PTO + 8 Paid Holidays
• Dynamic, fast-paced work environment
• Opportunity to work on Continuous Improvement Processes

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. 

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