Biotechnologist Associate

Job Description:
The Manufacturing Associate is responsible for producing therapeutic proteins (Active Pharmaceutical Ingredient API) under cGMP conditions. This role involves executing process recipes, following Standard Operating Procedures (SOPs), monitoring equipment and processes, performing basic laboratory tasks, and maintaining a clean and compliant manufacturing environment.
Responsibilities:

• Execute manufacturing processes according to SOPs and process recipes under cGMP guidelines.
• Operate and monitor production equipment, including Clean-in-Place (CIP) and Steam-in-Place (SIP) systems.
• Perform basic laboratory tasks such as pH and conductivity measurements, sampling, and documentation.
• Maintain facility and equipment cleanliness through routine sanitization and support 6S programs.
• Accurately document all activities in compliance with Good Documentation Practices (GDP).
• Handle material movements: transfer raw materials and chemicals within production areas.
• Participate in administrative tasks such as shift exchanges, meetings, and project work.
• Work in a cleanroom environment with proper gowning and aseptic techniques.
• Perform other duties as assigned.

• Bachelor's degree in Life Sciences, Biotechnology, Chemistry, or related field preferred.
• Associate degree or relevant technical certification considered.
• Prior experience in manufacturing, pharmaceutical, or biotech industry preferred.

• Food service/cooks (recipe following).
• Pharmacy technicians.
• EMTs, nurses/nurse aides.
• Mechanical/technical roles (robotics, tech support).
• Security guards.
• Roles requiring SOP adherence and regulatory compliance.

• Basic understanding of cGMP compliance and aseptic techniques.
• Ability to follow written procedures and maintain accurate documentation.
• Mechanical aptitude and comfort with automated systems.
• Strong computer skills for operating automated equipment.
• Attention to detail and ability to work in a regulated environment.
• Willingness to work in cleanroom conditions and wear appropriate gowning.