Manufacturing Associate I - Downstream

Cytovance Biologics - Oklahoma City, OK

Full-time

Oklahoma City, OK

Administrative and Support Services

About the position

This position is responsible for executing purification manufacturing procedures and supporting the manufacturing area by adhering to standard operating procedures (SOPs) and batch records. The role involves operating production equipment for purification, conducting in-process testing, and collaborating with cross-functional teams to meet production demands while ensuring compliance with Good Manufacturing Practices (cGMP).

Responsibilities

• Perform in-process testing where applicable.
• Interface with the Quality Control department to submit in-process samples and coordinate environmental monitoring during key process steps.
• Provide support to cross-functional teams to meet production or timeline demands.
• Demonstrate understanding in scientific concepts, technical operations, safety, and Good Manufacturing Practices.
• Provide suggestions for process optimization and efficiency, where applicable.
• Accurately follow SOPs for operating production equipment and performing processing steps.
• Follow specific techniques and operations while demonstrating an understanding of cGMPs and how they apply to specific responsibilities.
• Assume ownership of production areas and associated equipment.
• Assemble, prepare, and maintain process equipment; chromatography skids, columns, TFF systems, and ancillary equipment.
• Complete and review GMP documentation and production records for accuracy and make corrections promptly.
• Initiate non-conforming events and execute corrective actions/preventative actions.
• Adhere to Quality standards and learn and comply with regulatory requirements.

Requirements

• Associate Degree in Science or Chemical Engineering or 2 years of experience in GMP production and purification including aseptic processing, chromatography, TFF, Final Formulation and Filling, and buffer preparation.
• Must be highly motivated and able to follow oral and written instructions.
• Effective communication skills and logical thinking ability.
• Ability to thrive independently and/or in a fast-paced team environment.
• Proficient in Word and Excel.
• Ability to interpret process trends and data and react appropriately to unexpected outcomes.
• Innovative spirit, strong initiative, work ethic, and positive attitude.
• Ability to work flexible hours and inconsistent schedules as necessary to meet production demands and timelines.
• Detail-oriented and able to follow written instructions and document work performed.