Supervisor Manufacturing Leader

Company: WuXi AppTec
Location: Philadelphia
Posted on: November 2, 2024

Job Description:

Job SummaryWe are seeking an experienced Manufacturing Supervisor to join our team at WuXi AppTec. This role will be responsible for providing direct oversight and leadership in the manufacture of Master and Working Cell Banks and performing activities within production facilities to support the manufacture of Cell & Gene Therapy products according to current Good Manufacturing Practices (cGMPs).Key Responsibilities

• Understand and oversee the training, coaching, and mentoring of others on basic aseptic operational techniques, solution, material preparation, and facility start-up engineering and mechanical knowledge.
• Understand, teach, and coach others on all operations, functions, capabilities of equipment, and ancillary support to equipment, and perform complex troubleshooting.
• Drive sourcing and purchasing of standard, new, and complex equipment.
• Review and approve solution and material preparation results and resolve issues.
• Review protocols and other technical transfer documents.
• Identify and drive the application of GMP concepts and recommend improvements as the process develops during phases of technical transfer.
• Execute in-house and offsite validation activities.
• Forecast and perform material procurement activities.
• Use all support systems, such as LIMS, with demonstrated proficiency and act as a subject matter expert (SME) or super user.
• Act as a lead, member, or champion to design new systems or improve existing ones.
• Understand manufacturing processes and methods and train, coach, mentor, and manage the performance of others on basic operations such as media preparation, thaw, passage, and harvesting, as well as specific unit operations and overall systems across assigned programs.
• Interpret data and draw conclusions.
• Identify process and method gaps and opportunities and implement improvements across assigned programs and site-specific areas.Requirements
  • High School Diploma or equivalent required.
  • 5+ years of relevant technical experience and at least 2 years in a lead, leadership, or supervisory role.
  • Bachelor's degree in a science-related field preferred, or a combination of relevant experience and education.Preferred Qualifications
    • Demonstrated Lean/Six Sigma knowledge.
    • Ability to accurately and reproducibly perform arithmetic calculations, including fractions, decimals, and percentages, and basic algebraic and geometric calculations.
    • Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices.
    • Basic financial knowledge and acumen.
    • Basic and fundamental engineering and mechanical knowledge, with the ability to apply it in the manufacturing area, demonstrating unit operational and end-to-end understanding.
    • Technical knowledge and background in the pharmaceutical and biotechnology industry, specifically in cell and gene therapy.
    • Proficient in oral and written communication skills.
    • Ability to read, write, and understand English.
    • Proficient in Microsoft (Excel, Word, Outlook).

Keywords: WuXi AppTec, East Brunswick , Supervisor Manufacturing Leader, Other , Philadelphia, New Jersey