Supervisor, QC Analytical Lead

3 weeks ago


Harmans, Maryland, United States Catalent Inc Full time
Job Summary

The Supervisor, QC Analytical is responsible for leading analytical testing, investigations, and key deliverables for the Quality Control (QC) group. This role requires expert technical knowledge, mentoring direct reports on basic scientific/regulatory principles, and maintaining a strong commitment to scientific excellence and compliance within the department.

Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide.

Key Responsibilities:

  • Supervise the day-to-day operations in assigned areas of the QC department.
  • Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhere to safety guidelines.
  • Drive department process improvements to increase efficiency and compliance.
  • Ensure department adherence to batch record, stability protocol timelines, and deliverable dates.
  • Responsible for document writing (laboratory investigations, out-of-specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trending.
  • 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/department goals and practices and apply them when resolving a variety of problems.
  • Oversee 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 to support resolution of concerns/hurdles seen during GMP manufacturing campaigns, ongoing stability studies, and method verifications.

Requirements:

  • Bachelor's in a Life Sciences discipline with 6-8 years of experience working in a cGMP QC laboratory.
  • Masters' in a Life Sciences discipline with 4-6 years of experience working in a cGMP QC laboratory.
  • Experience with ELISA, ddPCR, qPCR, Empower 3 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.
  • Expert experience with biochemistry, as well as generating/reviewing the documentation that supports such work.
  • Expert knowledge and ability to apply basic scientific and regulatory principles to solve operational, as well as routine quality tasks.

Why Catalent?

Catalent is a dynamic, fast-paced work environment that offers competitive medical benefits and 401K, 152 hours PTO + 8 Paid Holidays, and opportunities to work on Continuous Improvement Processes.

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.



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