Biotechnologist Associate

Job Description:
The Manufacturing Associate is responsible for executing manufacturing operations for therapeutic protein (API) production under cGMP conditions. This includes operating equipment, following SOPs, performing basic lab tasks, and maintaining cleanroom standards. The role requires strong attention to detail, adherence to procedures, and willingness to work in a highly regulated environment.

Responsibilities:

• Execute process recipes and follow written procedures (SOPs) for API manufacturing.
• Operate and monitor production equipment including CIP (Clean-in-Place) and SIP (Steam-in-Place) systems.
• Perform basic lab tasks such as pH and conductivity testing, sampling, and product testing.
• Conduct material movements: transfer raw materials and chemicals across production areas.
• Maintain facility and equipment through routine cleaning and sanitization.
• Support 6S and lean manufacturing initiatives.
• Document production activities in both written and electronic formats per GMP/GDP standards.
• Participate in administrative tasks: shift exchanges, meetings, emails, and project support.
• Demonstrate aseptic technique and gowning compliance in cleanroom environments.
• ttain qualifications for assigned tasks and maintain an active training plan.
• Perform other duties as assigned.

Requirements:

• ssociate's or bachelor's degree in Life Sciences, Biotechnology, Chemistry, or related field preferred.
• Candidates with relevant certifications or coursework in science or manufacturing will be considered.
• bility to follow SOPs, guidelines, and industry regulations.
• Basic understanding of cGMP and GDP principles (training provided).
• Willingness to work night shifts and weekends on a rotating schedule.
• Comfortable working in cleanroom environments with full gowning.
• Strong attention to detail and documentation accuracy.
• Mechanical aptitude and ability to operate automated systems.

Preferred Backgrounds (Successful Transitions):

• Candidates with the following backgrounds have shown success in similar roles, especially when combined with scientific education or interest.
• Food service or cooks (recipe-driven environments).
• Pharmacy technicians.
• EMTs or healthcare support roles.
• Security guards or Sig Sauer employees.
• Tech support or computer-savvy individuals.
• Robotics or mechanical experience.
• Nurses or nurse aides.
• Candidates with strong SOP-following experience in regulated environments.