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About the job

Summary

A leading biotechnology organization in the Cell & Gene Therapy sector is seeking a Contract Manufacturing Associates to support the production of advanced therapies. This role involves operating both automated and manual equipment to support manufacturing processes in a cGMP environment. The position requires adherence to standard operating procedures (SOPs), quality standards, and safety protocols. The ideal candidate will have demonstrated experience in aseptic processing, specifically in the area of upstream cell culture while working within a Biosafety Cabinet (BSC) environment. This role also includes performing in-process quality control checks, handling biological materials, and contributing to continuous improvement initiatives.

Essential Duties and Responsibilities

• Operate manufacturing equipment and perform manual tasks in support of advanced cell & gene therapy production.
• Follow SOPs and regulatory guidelines (e.g., cGMP, GxP) to ensure compliance and product quality.
• Perform quality control evaluations during and after production processes.
• Maintain accurate documentation and assist in drafting and revising SOPs.
• Collaborate with cross-functional teams to support production goals and resolve issues.
• Execute cleaning and sanitization procedures for equipment and cleanroom areas.
• Handle biological materials safely, following hazardous material handling protocols.
• Support investigations and corrective/preventive actions related to quality and safety.
• Maintain a safe work environment and complete required training on time.

Qualifications Required:

• Experience in a cGMP-compliant manufacturing environment.
• High school diploma or equivalent with at least 2 years of relevant education or work experience.
• Ability to work full-time, M-F day-shift
• Strong attention to detail and ability to follow procedures accurately.
• Effective communication and teamwork skills.
• Ability to lift and move materials up to 50 pounds and stand or sit for extended periods.
• Proficiency in basic math and unit conversions.
• Familiarity with Microsoft Office applications.

Preferred:

• Associates or Bachelor's degree in a scientific or engineering discipline.
• Knowledge of biologic, cell, and/or gene therapy manufacturing processes.
• Experience with quality systems and documentation practices

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