Manufacturing Associates III; Second Shift

Manufacturing Associate III

Aspen Neuroscience is expanding its team to support clinical production with the implementation of a new shift schedule to begin in 2027. These are on-site roles in Torrey Pines, CA. Relocation is not available.

We are seeking Manufacturing Associate III candidates with a minimum of 5 years of experience working in pharmaceutical/biotechnology industry with first-hand understanding of mammalian cell culture.

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.

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).

From Date of Hire until completion of training program, new hires will work M-F (7:00-3:30) pm. Upon training completion, employees will transition to Sunday
-Thursday or Tuesday
- Saturday maintaining the same work time until transitioning to 12- hour shift in January 2027.

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.

Monitor and mentor newly trained associates in established areas of proficiency, providing feedback and support to promote independent task execution and quality performance.

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.

Assist 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.

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.

CMC Knowledge:
Working knowledge of CMC development and manufacturing concepts, with the ability to apply…