Manufacturing Associate 2

The Biotech Manufacturing Associate 2 will support the production of biologic drug products in a GMP-compliant manufacturing environment. This role will involve hands-on activities related to the production of biologics, ensuring the safe, efficient, and timely manufacturing of products. The ideal candidate will have experience in biotech manufacturing and be familiar with standard operating procedures (SOPs), equipment operation, and the ability to troubleshoot and resolve manufacturing issues.

Responsibilities:

• Perform routine and non-routine operations within the manufacturing process for biologic drug production, including but not limited to mammalian cell culture, purification, and aseptic processing.
• Perform manufacturing tasks such as media and solution preparation with precision and attention to detail.
• Operate and maintain manufacturing equipment and instrumentation, ensuring compliance with all applicable SOPs and safety guidelines.
• Complete batch records, logbooks, and documentation in accordance with Good Manufacturing Practices (GMP) and company policies. Maintain accurate records to ensure traceability and accountability.
• Identify, escalate, and resolve process or equipment issues as they arise, coordinating with senior team members or leadership as necessary.
• Ensure that all production activities comply with regulatory requirements, quality standards, and company procedures.
• Work closely with cross-functional teams, including Quality Assurance, Quality Control, and Engineering, to ensure smooth operation of manufacturing processes.
• Contribute to continuous improvement initiatives aimed at optimizing manufacturing processes, improving yield, and reducing downtime.
• Adhere to all safety and environmental regulations, promoting a safe working environment for the team.

Candidate Required Qualifications:

• Bachelor’s degree in Biological Sciences, Biotechnology, Chemistry, or a related field; or equivalent relevant experience.
• Minimum of 2-4 years of experience in a GMP-compliant biotech or pharmaceutical manufacturing environment.
• Knowledge of biotech production processes (e.g., mammalian cell culture, protein purification, aseptic technique).
• Knowledge and/or experience in expanding adherent cell culture in T-flasks and cell factories along with equipment such as the iCELLis500 bioreactor system a plus.
• Strong understanding of GMP guidelines, FDA regulations, and other industry standards.
• Experience with process equipment and automated systems.
• Ability to troubleshoot and resolve operational issues.
• Strong attention to detail and documentation practices.
• Excellent communication and team collaboration skills.

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.