Upstream Supervisor (cGMP)
Oklahoma City, OK

The Upstream Manufacturing Supervisor will be responsible for overseeing the cell culture and upstream processing operations. As an integral part of our manufacturing leadership team, you will be instrumental in driving the production of top-tier biopharmaceutical products and lead a team of employees directly or indirectly during production processes.

Job Responsibilities

 Upstream knowledge and experience with the following:

• • Oversee and supervise GMP manufacturing processes for cell culture-based production, ensuring strict compliance with established protocols and regulatory standards.
    

  • Lead routine tasks such as media preparation, cell inoculation, bioreactor operation, and harvest operations, ensuring meticulous execution and adherence to quality parameters.
    

  • Foster collaboration with cross-functional teams, including Quality Control and Quality Assurance, to uphold product quality and regulatory compliance.
    

  • Spearhead troubleshooting efforts and resolution of process deviations, conducting root cause analyses and implementing corrective measures to optimize manufacturing efficiency.
    

  • Maintain comprehensive documentation of all manufacturing activities in accordance with GMP standards, ensuring the accuracy and completeness of batch records and related documentation.
    

  • Play a pivotal role in technology transfer activities, leveraging expertise in cell culture processes to contribute to process enhancement initiatives.
    

  • Facilitate the training and development of junior team members, actively participating in the formulation of standard operating procedures SOPs pertaining to cell culture manufacturing. Ensure the upkeep of equipment and work areas in accordance with safety protocols and guidelines, fostering a culture of safety and compliance. 
    

  
  

• Continuous flow centrifuges
  

• Homogenization and depth filtration operations
  

• Single-Use temperature controlled mixing systems
  

• Bulk fill and aseptic handling techniques
  

• Responsible for leading daily manufacturing activities, which will include training and supporting performance evaluations.
  

• Develop, write, and review Standard Operating Procedures, Compounding Records, and Batch Records.
  

• Ensure team execution of NetSuite functionality for batch material traceability.
  

• Responsible for review of executed production records for proper GDP and execution of production records.
  

• Support deviation and CAPA resolution with SME and quality teams.
  

• Provide input and support to MSAT/PD during development and scale up activities as necessary.
  

• Support equipment calibration and preventative maintenance as part of the equipment control program.
  

• Communicate safety policies and goals and ensure team members adhere to facility safety policies.

Education & Experience

• BS or MS from an accredited college or university with major coursework in a Scientific or Engineering discipline.
  

• Experience working in a GMP manufacturing environment is essential.
  

• The ideal candidate should possess over 6 years of relevant experience, demonstrating a strong proficiency in cell culture techniques and a track record of ensuring adherence to quality standards.
  

• Requires a strong background in cGMP principles and Quality Management Systems.

Job Details:

• Night Shift-11pm-7am
  

• Direct Hire Opportunity!
  

• Flexible to work overtime/weekends as needed
  

• Benefits Package

For immediate consideration, please forward  your updated resume.

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