Upstream Manufacturing Supervisor

We are in search of a proficient and seasoned Manufacturing Supervisor with expertise in GMP (Good Manufacturing Practice) environments, particularly in overseeing cell culture and downstream processing operations. 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. As an integral part of our manufacturing leadership team, you will be instrumental in driving the production of top-tier biopharmaceutical products.

Responsibilities:

• 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.

Candidate Required Qualifications:

• Bachelor’s degree in a pertinent scientific discipline (Biotechnology, Biochemistry, Biology, or a related field).
• Over 8 years of hands-on experience in GMP manufacturing, with a specialized focus on cell culture processes.
• Profound understanding of bioreactor operations, aseptic techniques, and upstream processing. Experience with tangential flow filtration, ultracentrifugation and bulk fill downstream operations is a plus.
• Experience with adherent cell culture preferred.
• Familiarity with regulatory requirements governing the production of biopharmaceuticals, including FDA and EMA guidelines.
• Exceptional problem-solving and analytical aptitude, coupled with the capacity to troubleshoot and refine manufacturing processes.
• Strong communication and collaboration skills, enabling effective interaction across departments and fostering a positive team dynamic.
• Detail-oriented with a demonstrated ability to maintain meticulous documentation in compliance with GMP standards.

Physical Requirements:

• Ability to perform lab-based tasks, including standing for long periods, working with various laboratory equipment, and handling biological samples.
• Must be able to lift and carry equipment, reagents, and materials weighing up to 25 pounds.

Professional Scope:

• JOB LEVEL: Assumes responsibility for developing professional expertise, applying company policies and procedures to resolve various issues.
• EXPERIENCE: Typically necessitates a university degree and a minimum of 8 years of relevant experience in a managerial or supervisory capacity.
• COMPLEXITY: Deals with challenges of moderate scope, requiring analysis of diverse factors. Exercises judgment within defined procedures and practices, fostering productive internal and external relationships.
• SUPERVISION: Generally receives general instructions for routine tasks, while detailed instructions are provided for new projects or assignments.

Location

Wheeler Bio’s headquarters are situated in Oklahoma City, OK. The selected individual is expected to operate onsite, necessitating relocation to the Oklahoma City headquarters to oversee this expanding team effectively.