Manufacturing Associates II (Day & Second Shift)

Duties and Responsibilities

• Maintain a GMP-controlled cleanroom environment during manual and automated cell culture processes.
• Execute setup, operation, and breakdown of automated cell culture systems, ensuring proper configurations and adherence to protocols.
• Participate in training and qualification activities, including gowning, aseptic technique qualifications, and facility simulations.
• Support training of new associates by demonstrating procedures and reinforcing safety practices and GMP expectations.
• Monitor and guide newly trained associates, escalating issues or training gaps as necessary.
• Coordinate with trainers and support groups to ensure production readiness, equipment availability, and material flow.
• Assist with ERP-related activities, including inventory tracking, Kanban management, material movements, and cycle counts.
• Assist with wiping and staging materials into training, controlled, and cleanroom areas.
• Review and manage manufacturing documentation, data trends, and basic data management activities.
• Attend cross-functional meetings as a subject matter expert (SME).
• Support process and assay development activities by assisting Process Engineers with manufacturing of development or engineering cell lots.
• Participate in cross-functional meetings as a manufacturing representative and contribute technical input.
• Write, review, and revise Standard Operating Procedures (SOPs), batch records, and quality documents, ensuring accuracy and compliance with GMP requirements.
• Assist with deviation investigations, Corrective and Preventative Action (CAPA) reports, non-conformance reports, and Out-of-Specification (OOS) documentation.
• Identify and report process issues, equipment concerns, or conflicts to appropriate supervisors or managers.
• Adhere to company policies, GMP requirements, and safety standards while maintaining quality and compliance.

Educations and Experience

• Associate degree or higher in a relevant technical discipline such as biology, chemistry, pharmaceutical sciences, biochemistry, biotechnology, molecular biology, or chemical/bioengineering.
• Minimum 2 years of experience working in a pharmaceutical or biotechnology setting.
• First-hand experience with cell culture (preferably adherent mammalian culture) and composing/supplementing media.
• Experience in cleanroom environments (ISO 7 and 5), fibroblast, primary tissue culture, and iPSC cells.
• Some trainer experience preferred.

Job Specifications

• Basic understanding of CMC development and manufacturing concepts, following established procedures in a GMP manufacturing environment.
• Ability to perform routine manual and automated cell culture activities in accordance with approved protocols, GMP requirements, and quality standards, with supervision.
• Foundational knowledge of GMP principles and awareness of ISO standards, Quality Systems, and FDA regulations applicable to manufacturing operations.
• Effective verbal and written communication skills, with the ability to follow instructions, document work accurately, and communicate status or issues to team members and supervisors.
• Basic computer skills, including use of Microsoft Office and other systems required for documentation and data entry.
• Working knowledge of cleanroom behavior, aseptic techniques, safety practices, and documentation requirements in a regulated environment, including working in a cleanroom environment while gowned for an extended period.
• Ability to work effectively as a member of a manufacturing team and coordinate with others to support assigned tasks and team objectives.
• Ability to complete batch records, logs, and other manufacturing documentation accurately and in compliance with GMP expectations, with guidance as needed.
• Ability to work a flexible schedule to support manufacturing operations, including overtime, weekend, and holiday work as business needs require.