Overview
Manager, QC Analytical Jobs in Harmans, Maryland, USA at Catalent
Location: Harmans
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, train new scientists on basic scientific/regulatory principles, possess initiative, and maintain a strong commitment to scientific excellence.
The role:
Manage the day-to-day operations in the 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 and performance management for direct reports.
Understand 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’s in a Life Sciences discipline with 8 – 10 years of experience working in a cGMP QC laboratory.
Master’s in a Life Sciences discipline with 6 – 8 years of experience working in a cGMP QC laboratory.
2 – 4 years of progressive leadership experience, experience with performance management, goal setting, and managing through conflict.
Experience with ELISA testing preferred but not required.
Expertise relevant to QC analytical methods used for protein chemistry and molecular biology.
Experience with in 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.
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 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 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 Disabili This option is reserved for individuals who require accommodation due to a disability.
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Title: Manager, QC Analytical
Company: Catalent
Location: Harmans, Maryland, USA
Category: Healthcare, Quality Assurance – QA/QC
