Sr. QC Scientist - QC Analytical

The Senior Scientist, QC Analytical is responsible for supporting analytical testing in order to support GMP manufacturing for both clinical and commercial clients. The Senior 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.

Shift: Monday-Friday 8:30am-5pm

The role:

• Perform assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, ddPCR, HPLC, Capillary Electrophoresis, Appearance, Osmo, and pH
• Troubleshoot testing issues, escalate all needs and provide potential resolutions to maintain successful deliverables to support batch release, stability testing and ad hoc testing.
• Mentor and develop other operational staff
• Act as a subject matter expert for at least two techniques. Understanding of the scientific nature, current industry norms, and functional working of testing in order to support discussion with auditors, vendors, instrumentation, method services, and other cross functional teams
• Drive cross functional teams in order to drive continuous improvement projects within the department
• Reports errors, deficiencies, discrepancies, and observations to management that could impact product Quality on release.
• Create, lead, and manage change requests (CR) and corrective and preventive actions (CAPA) needed to ensure production changes and improvements are implemented in a timely manner.

The candidate:

• Bachelor in a Life Sciences discipline with 4 – 6 years of experience working in a cGMP QC laboratory.
• Masters’ in a Life Sciences discipline with at least 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

The anticipated salary range for this position in Maryland is $93,280 - $128,260 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.

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