Manufacturing Associate 3

The Biotech Manufacturing Associate 3 is a key role within the biotechnology manufacturing team. This individual will work in a regulated environment to support the production of biopharmaceutical products. The role requires advanced technical knowledge, experience in GMP (Good Manufacturing Practices), and the ability to lead and mentor junior staff. The ideal candidate will have a strong understanding of the manufacturing process, equipment operation, troubleshooting, and documentation to ensure the successful production of high-quality products. Wheeler Bio’s headquarters are in Oklahoma City, OK. Because it is expected that this individual will work and operate onsite, he or she will be required to relocate to the Oklahoma City headquarters to lead this expanding team.

Responsibilities:

• Operate and maintain bioprocessing equipment such as bioreactors, chromatography systems, filtration units, and other related biotechnology equipment.
• Execute production procedures for mammalian cell culture, filtration, purification, and other biotech manufacturing processes in compliance with GMP and standard operating procedures (SOPs).
• Lead and support manufacturing batches, ensuring timely execution of production steps and maintaining batch records in accordance with established protocols.
• Review and approve batch records, logbooks, and other production documentation for accuracy and completeness.
• Perform equipment setup, cleaning, calibration, and maintenance to ensure continuous, optimal functioning of manufacturing systems.
• Monitor production processes and identify any deviations or anomalies; troubleshoot issues as necessary and escalate to the appropriate level of management.
• Maintain a clean and safe working environment by following appropriate safety protocols, regulations, and cleanliness standards.
• Conduct routine quality control checks and collaborate with Quality Assurance (QA) to ensure products meet quality standards and compliance.
• Provide training and guidance to junior manufacturing associates and assist in process improvements.
• Collaborate with cross-functional teams (e.g., QA, Process Development, Facilities) to ensure the smooth execution of manufacturing processes and timely product delivery.
• Contribute to investigations of deviations, root cause analyses, and CAPA (Corrective and Preventive Actions) when issues arise.
• Participate in continuous improvement initiatives to enhance process efficiency, product quality, and safety.

Candidate Required Qualifications:

• Bachelor’s degree in a relevant scientific field (Biotechnology, Biochemistry, Chemical Engineering, or similar) or equivalent work experience.
• 3-5 years of experience in biotech or pharmaceutical manufacturing, preferably in a GMP environment.
• Hands-on experience with operating bioprocessing equipment (e.g., bioreactors, chromatography systems) and related systems.
• Strong knowledge of GMP regulations, batch record documentation, and quality control processes.
• Ability to troubleshoot and resolve technical issues independently and within a team setting.
• Strong communication skills and the ability to train and mentor junior staff members.
• Experience with data review, analysis, and reporting.

Candidate Preferred Qualifications:

• Knowledge and/or experience in expanding adherent cell culture in T-flasks and cell factories along with equipment such as the iCELLis500 bioreactor system.
• Experience in sterile techniques, aseptic processing, and environmental monitoring.
• Knowledge of bioprocess automation and data management systems (e.g., SCADA, DeltaV).
• Certification in relevant industry standards (e.g., GMP, ISO).

Physical Requirements:

• Ability to lift up to 10 pounds.
• Ability to stand, walk, and perform repetitive tasks for extended periods.
• Willingness to work in a cleanroom or controlled environment (PPE required).

Working Conditions:

• This position requires flexibility in working hours, including potential shift work, weekends, and on-call duties as necessary.
• Work is performed in a regulated, cleanroom environment and involves the handling of biological materials.

Why Wheeler Bio?

• Opportunity to work with cutting-edge biotechnology in a rapidly growing field.
• Competitive compensation and benefits package.
• Collaborative and inclusive work environment.
• Professional development and growth opportunities.