Biotech Manufacturing Associate 1

Department: Manufacturing

Reports To: Director of Manufacturing

Position Overview

We are seeking a motivated and detail-oriented Biotech Manufacturing Associate 1 to join our team in a dynamic and fast-paced biotech manufacturing environment. As a key member of our manufacturing team, the associate will assist with the production of biopharmaceutical products, following strict adherence to regulatory standards, safety protocols, and company guidelines.

Key Responsibilities

-         Operate and monitor manufacturing equipment, including bioreactors, filtration units, and chromatography systems, ensuring compliance with SOPs (Standard Operating Procedures).

-         Assist with the preparation, assembly, and sterilization of production equipment and materials used in the manufacturing process.

-         Maintain accurate and detailed records of manufacturing processes, batch production, and product testing in compliance with GMP (Good Manufacturing Practices).

-         Perform routine equipment maintenance and troubleshooting to ensure operational efficiency and minimize downtime.

-         Support the execution of in-process testing, sampling, and documentation of results as part of quality assurance protocols.

-         Collaborate with cross-functional teams including Quality Control, Research and Development, and Supply Chain to ensure the timely and accurate production of biopharmaceutical products.

-         Adhere to safety guidelines, cleanliness, and environmental protocols to maintain a safe and compliant work environment.

-         Assist in the preparation and execution of validation and qualification activities as needed.

-         Participate in continuous improvement efforts to optimize production efficiency, product quality, and compliance.

-         Contribute to the training of new associates as needed.

Qualifications

-         High school diploma or equivalent; Associate’s degree in Biotechnology, Biology, Chemistry, or related field preferred.

-         0-2 years of experience in a biotech or pharmaceutical manufacturing environment.

-         Basic knowledge of Good Manufacturing Practices (GMP), cleanroom environments, and safety protocols preferred.

-         Familiarity with basic lab equipment and manufacturing tools is a plus.

-         Ability to work in a team-oriented environment and collaborate effectively across departments.

-         Strong attention to detail, organizational skills, and the ability to manage multiple tasks simultaneously.

-         Ability to follow written and verbal instructions accurately.

-         Willingness to work in shifts (e.g., day, night, or rotating shifts) as required.

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).

Additional Information

-         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.