Manager, QC Analytical

The Manager, QC is responsible for leading analytical method transfers and method qualifications between the Pre-Clinical and Process Development group and Quality Control (QC).   The Manager, QC must demonstrate expert technical knowledge, trains new scientist on basic Scientific/regulatory principles, possess initiative, and maintains 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:

• Manage the day to day operations in assigned area of the QC Analytical department.
• Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines 
• Build effective teams that apply their diverse skills and perspectives to achieve common goals.
• Drive engagement and create a culture where employees are motivated to do their best.
• Oversee daily activity for the group to ensure quality results Performance management for direct reports.
• Understands company goals and practices and apply them when resolving a variety of problems.
• Perform assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, RT-PCR, HPLC and Capillary Electrophoresis
• Generate internal and external documents such as assay protocols, summary reports, and SOPs
• Work with clients during initial and subsequent transfer of assays and analytical methods to support GMP manufacturing campaigns

The candidate:

• Bachelor in a Life Sciences discipline with 8 – 10 years of experience working in a cGMP QC laboratory.
• Masters’ in a Life Sciences discipline with 6 – 8 years of experience working in a cGMP QC laboratory.
• 2 – 4 Progressive Leadership experience, experience with Performance Management, Goal Setting and Managing through Conflict.
• Experience with ELISA testing preferred but not required.
• Expert 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

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