WuXi AppTec

Supervisor, Cell Therapy Manufacturing

US-PA-Philadelphia
Job ID
2017-2986

Overview

The Manufacturing Supervisor provides on-the-floor production leadership to ensure that manufacturing processes are optimized and managed efficiently.

 

Demonstrates strong supervisory skills and contributes to the achievement of company and departmental goals and objectives.  Has a strong working knowledge of the regulatory compliance requirements for the commercial production of biologics.  Remains current regarding current Good Manufacturing Practices (cGMP) guidelines and develops and/or modifies production methods to fully address compliance issues.  Demonstrates innovative technical knowledge and significantly contributes to the overall manufacturing operations. Demonstrates strong oral and written communication skills and actively contributes to training, report generation and documentation.  Participates in manufacturing operations in assigned area. Analyzes scientific data with accuracy and precision, critical at time of processing.   

Responsibilities

  • Schedule and coordinate day-to-day manufacturing operations. Ensure conformance to the daily production schedule.
  • Provide clear objectives for daily manufacturing operations to meet customer and cGMP requirements.
  • Train, develop and supervise personnel in assigned activities
  • Work closely with all operations support functions (Quality Assurance, Quality Control, Facilities, Engineering, Validation, Project Management and Materials Management groups) to ensure that Company objectives are met on schedule. Interact with material/equipment vendors and commercial partners, as required.
  • Ensure full compliance with CGMPs and applicable health and safety regulations (OSHA) is achieved and maintained
  • Author and revise SOPs and batch records
  • Ensure cGMP compliance, confirming that all production equipment is properly working and production processes meet quality standards.
  • Perform review of batch documentation and logbooks for completeness and accuracy.
  • Establish objectives and conduct performance reviews, monitoring progress toward objectives and provide timely and professional feedback to Manufacturing Management
  • Timely status communication of operations, safety and maintenance problems to Area Management.
  • Participate in internal meetings, client audits, and conference calls as appropriate.
  • Author and contribute to deviations/investigations, Corrective/Preventative Action initiatives, Change Control procedures, technical protocols and logistical planning
  • Ensure equipment and facilities are serviced and maintained properly
  • Contribute data to routine metric reports

Additional duties may include:

  • Author and contribute to deviations/investigations, Corrective/Preventative Action initiatives, Change Control procedures, technical protocols and logistical planning
  • Ensure equipment and facilities are serviced and maintained properly
  • Contribute data to routine metric reports

Qualifications

  • High School diploma and at least 6 years in cell production/biologics facility or Bachelor’s degree with major in Biology, Chemistry or related Science major and 4 - 6 years of experience in cell production/biologics facility or equivalent.
  • Meets physical requirements of the job, as follows:  must have the ability to lift a minimum of 50 pounds, stand for long periods, bend, reach, stretch, climb ladders and work in tight spaces in order to complete job tasks.
  • Significant experience in aseptic processing techniques and a thorough understanding of regulatory requirements for a cGMP manufacturing facility is required.
  • Ability to work under limited supervision and to handle problems of a more difficult nature.

We are an equal opportunity employer - disabled/veterans.

 

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