Manufacturing Associate III; Second Shift

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.

Role Overview :

We are seeking

Manufacturing Associate IIIcandidateswith a minimumof5 years of experience working in pharmaceutical/biotechnology industry with first-hand understanding of mammalian cell culture.

Key Focus Areas:

This role is assigned to amanufacturing supervisor and directs, assists, instructs, and reviews the daily work in the designated Manufacturing area.

This includes all activities associated with cell-relatedfunctions;including producing cells and intermediate products related to induced pluripotent stem cells (iPSC) derived dopaminergic progenitor cells. This roleis responsible for ensuring the approved procedures and protocols arefollowedperSOP.

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) andSecond

Shift (11:30am – 11:30pm.)

Training Period:

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
- Saturdaymaintainingthe same work time until transitioning to 12- hour shift in January 2027.

• Manufactureclinical cell therapy products in aGMP‑controlledcleanroom 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, ensuringaccurateconfiguration and adherence toestablishedprotocols.
• Develop and expand operationalproficiencywith 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 ofintermediatesand finished goods across all manufacturing stages.
• Support daily manufacturing operations byassistingleads and management with work coordination, including task distribution and prioritization tomaintaincontinuous product flow.
• Assist with routinefloor‑leveloperational 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 torole 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, andassistassociates with training or documentation questions as needed.
• Troubleshoot routine manufacturing process issues and product challenges, collaborating with internal and external partners to supporttimelyand compliantresolution.
• 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 whilemaintainingconsistent 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…