Manufacturing Associates III (Day & Second Shift)

Key Focus Areas

This role is assigned to a manufacturing supervisor and directs, assists, instructs, and reviews the daily work in the designated Manufacturing area. This includes all activities associated with cell-related functions; including producing cells and intermediate products related to induced pluripotent stem cells (iPSC) derived dopaminergic progenitor cells. This role is responsible for ensuring the approved procedures and protocols are followed per SOP.

Shift Details

Beginning January 2027, Associates will work 12-hour shifts rotating on a 2-2-3 “Pitman” Schedule. The two shifts available are the Day Shift (5:00am – 5:00pm) and Second Shift (11:30am – 11:30pm).

Duties And Responsibilities

• Manufacture clinical cell therapy products in a GMP-controlled cleanroom environment, performing manual and automated cell culture activities in accordance with approved procedures and quality standards.
• Perform and provide oversight support for the setup, operation, and breakdown of automated cell culture systems, ensuring accurate configuration and adherence to established protocols.
• Develop and expand operational proficiency with the goal of serving as a knowledgeable resource (SME) for assigned manufacturing processes, equipment, or techniques.
• Execute all manufacturing operations, including inventory management, move orders, and the production of intermediates and finished goods across all manufacturing stages.
• Support daily manufacturing operations by assisting leads and management with work coordination, including task distribution and prioritization to maintain continuous product flow.
• Assist with routine floor-level operational decisions, such as activity prioritization and break coverage, when Lead or Management are unavailable.
• Instruct and train manufacturing associates on job procedures, equipment operation, safety practices, and GMP expectations, as appropriate to role and experience level.
• Maintain manufacturing and process development equipment and inventory, including support of material readiness and Kanban processes.
• Review daily manufacturing logs, batch records, and documentation for accuracy and completeness, and assist associates with training or documentation questions as needed.
• Troubleshoot routine manufacturing process issues and product challenges, collaborating with internal and external partners to support timely and compliant resolution.
• Support testing and release of raw materials and new reagent lots, including participation in comparative evaluations of alternate materials in collaboration with Quality Control.
• Aid management with documentation review, ERP activities (inventory, equipment maintenance, and supply orders), data trending, and participation in meetings as a SME.
• Write, review, and revise SOPs, batch records, and quality documents, ensuring accuracy and compliance with GMP requirements.
• Perform deviation investigations, write impact assessments, CAPAs, NCMRs, and OOS documentation by gathering information and completing assigned actions.
• Adhere to company policies, GMP requirements, and safety standards while maintaining consistent quality and compliance performance.
• Perform other assigned duties consistent with role scope and training.

Education And Experience

• Bachelor’s, or equivalent industry experience in a relevant technical discipline such as biology, chemistry, pharmaceutical sciences, biochemistry, molecular biology, chemical engineering or equivalent
• Minimum 5 years of experience working in pharmaceutical/biotechnology industry with first-hand understanding of mammalian cell culture, composing and supplementing media, cleanroom (ISO 7 and 5), (automation, fibroblast, primary tissue culture, and iPSC cells a plus).
• Equivalent combination of knowledge and experience will be considered.
• Trainer experience.
• Experience with cell culture operations and familiarity with execution and troubleshooting of moderate to complex scheduling activities is a must.

Job Specifications

• CMC Knowledge: Working knowledge of CMC development and manufacturing concepts, with the ability to apply established procedures within GMP manufacturing environments.
• Cell Culture Skills: Demonstrated ability to perform manual and automated cell culture techniques in accordance with approved protocols, GMP requirements, and quality standards.
• Regulatory Awareness: Working knowledge of ISO standards, Quality Systems, and FDA regulations applicable to regulated manufacturing operations.
• Communication Skills: Effective oral and written communication skills, with the ability to follow instructions, document work accurately, and communicate clearly with team members.
• Technical Skills: Proficient computer skills, including the use of Microsoft Office and basic project or task-tracking tools to support daily operations and documentation.
• GMP & Aseptic Practices: Knowledge of GMP principles, aseptic processing techniques, cleanroom operations, safety practices, and required documentation practices.
• Collaboration: Ability to work effectively within a cross-functional team environment to support manufacturing activities and quality objectives.
• Flexibility: Ability to work a flexible schedule, including overtime, weekend, and holiday work, based on manufacturing and business needs.
• Technical Writing: Ability to complete accurate and compliant documentation, including reports, SOPs, batch records (BRs), and quality-related documents with guidance.