Scientist, QC Analytical

The Scientist, QC is responsible for supporting analytical testing in order to support GMP manufacturing for both clinical and commercial clients. The Scientist, QC must demonstrate technical knowledge, be familiar with basic scientific/regulatory principles, possess initiative, and maintain a strong commitment to scientific excellence. 

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:

• Perform assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, ddPCR, HPLC, Capillary Electrophoresis, Appearance, Osmo, and pH
• Documenting testing per GMP/GDP procedures
• Generate internal and external documents such as assay protocols, summary reports, and SOPs
• Analytical support to QC method services of method verification of platform test methods
• Supports release and stability testing for raw materials, components, standards, intermediate/finished products
• Generate internal and external documents such as summary reports, and SOPs
• Reviews laboratory work and approves data packages as designated by the Supervisor
• Provide instrumentation care, maintenance, troubleshooting, and data interpretation
• Responsible for document writing (laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trending

The candidate:

• Bachelor in a Life Sciences discipline with 2 – 4 years of experience working in a cGMP QC laboratory.
• Masters’ in a Life Sciences discipline with 0 – 2 years of experience working in a cGMP QC laboratory.
• Experience with any of the following techniques is preferred ELISA, qPCR, ddCPR, HPLC,CE
• Knowledge/expertise relevant to QC analytical methods used for protein chemistry and molecular biology
• Experience within the biologic, pharmaceutical, or medical device industry performing direct hands-on work in QC function with a strong familiarity of general GMP practices
• Experience in writing SOPs
• Broad experience with biochemistry, as well as generating/reviewing the documentation that supports such work
• Proficient knowledge and ability to apply basic scientific and regulatory principles to solve operational, as well as routine quality tasks

The anticipated salary range for this position in Maryland is $74,080-$101,860 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 applicat