Downstream Manaufacturing Supervisor
BS/BA or Associates Degree in biological sciences, chemical sciences, engineering or equivalent technical discipline
Degree in other discipline if sufficient technical depth has been achieved from professional experience.
- Minimum of 8 years of directly related experience in the Pharmaceutical or Biotechnology industry
- Knowledge and experience in a production area (e.g. cell culture, microbial fermentation, buffer prep, media prep, purification, etc.).
- Clear understanding of the control systems used to run processes in modern large scale Biopharmaceutical plants.
- Strong verbal and written communication skills which emphasize teamwork and a strong quality orientation.
- Strong team player with demonstrated ability to lead and motivate a diverse team.
- Demonstrated ability to solve complex technical problems
- Strong quality/compliance orientation and track record.
- Excellent interpersonal and leadership skills.
- Strong influence and relationship building skills with an emphasis on teamwork.
Comprehensive understanding of Lean/Six Sigma (OE) principles and their application.
MS/MA in Biological sciences, chemical sciences, engineering or equivalent technical discipline
- Provides first-line supervision (on either day, swing or night shift) to a staff of Manufacturing Associates who conduct: microbial fermentation, cell culture or purification unit operations including overseeing preparation of media and buffers, seed lab operations, large scale microbial fermentation and/or cell culture, harvest and recovery operations, chromatographic processing, filtration and concentration operations, and the ordering of raw materials and components from the warehouse. Production Supervisors are expected to have the capability to perform aforementioned activities alongside Manufacturing Associates.
- Perform duties in a compliant manner and behave in accordance with site SOP's, GSK EHS standards and guidelines and relevant legal requirements and ensure that their team do the same.
- Assures that the preparation of bulk biopharmaceutical intermediates meets all quality standards for cGMP, GSK and any other applicable regulatory agency.
- Supports successful implementation of new products and processes into the facility, including all appropriate equipment and area changeover activities.
- Lead new production projects, develop commissioning plans and author commissioning documents
- Effectively troubleshoot production equipment and processing problems of varying scope
- Accountable for Manufacturing Associate development and/or performance management though activities such as assignments and associated technical training programs.
- Ensure all staff are adequately trained on all cGMP manufacturing operations and documentation.
- Work on problems of advanced scope, potentially cross-functional, where analysis of situation or data requires a review of identifiable and unknown factors
- Participate and implement continuous improvement and operational excellence methods and tools to improve the overall efficiency of production operations.
Job Description Summary-Job Family - Production/Manufacturing Operations:
Sets up and operates automatic or semiautomatic machines and related equipment in a continuous production/processing operation.
Manufactures sufficient quantities of quality products at or below budgeted production costs to meet marketplace demand.
Monitors meters, gauges, valves, flow ratios, temperatures, pressures, and related controls and guidelines to ensure adherence to production/process specifications.
Resolves issues related to the organization's production, machinery, processing and/or packaging operations.
Follows established procedures and respects Good Manufacturing Practices (GMP) concerning quality, safety and hygiene.
Job Family Group - Manufacturing:
Responsible for the organization's manufacturing and/or production operations including assembly, machinery, processing and/or packaging.
Sets production schedules based on product introduction, equipment efficiency, materials supply, staffing resources, and volume required to meet demand and to ensure maximum production quantity and quality.
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