Manufacturing Associates II; Second Shift

Manufacturing Associate II

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 II candidates with 2+ years of experience working in a pharmaceutical or biotechnology setting. This is an excellent opportunity to continue building a career in biotechnology and clinical cell therapy manufacturing.

Key Focus Areas:
This role supports the production of cells and intermediate products related to fibroblasts, induced pluripotent stem cells (iPSCs), and derived dopaminergic progenitor cells.

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).

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
- Saturday maintaining the same work time until transitioning to 12- hour shift in January 2027.

Duties and Responsibilities:

• Manufacture clinical cell therapy products in a GMP-controlled cleanroom environment, including execution of manual and automated cell culture processes in accordance with approved procedures and quality standards.
• Perform setup, operation, and breakdown of automated cell culture systems, ensuring proper configuration, handling, and adherence to established protocols.
• Participate in required training and qualification activities, including gowning, aseptic technique qualifications, and equipment, facility, and aseptic process simulations.
• Support training of lower-level manufacturing personnel by demonstrating assigned procedures and reinforcing proper techniques, safety practices, and GMP expectations.
• Monitor and provide guidance to newly trained associates in areas of established proficiency, escalating issues or training gaps as needed.
• Coordinate with trainers and support groups (e.g., Quality, Materials Management, Facilities) to support production, equipment readiness, and material availability.
• Assist with ERP-related activities, including inventory tracking, Kanban maintenance, material movements, and completion of cycle counts.
• Assist with wiping and staging material into training, controlled, and cleanroom areas.
• Perform review of manufacturing documentation, data trending, and basic data management activities in support of operational monitoring.
• 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 within area of experience.
• Write, review, and revise SOPs, batch records, and quality documents with guidance, ensuring accuracy and compliance with GMP requirements.
• Assist with deviation investigations, CAPAs, non-conformance reports, and OOS documentation by gathering information and completing assigned actions under supervision.
• Identify and report process issues, equipment concerns, or conflicts to the Lead, Supervisor, or Manager in a timely manner.
• Adhere to company policies, GMP requirements, and safety standards while consistently maintaining quality and compliance.
• Perform other assigned duties consistent with training and role level.

Education and Experience:

• Associate degree or higher and/or a Biotech Program certificate from an accredited college, or equivalent industry experience in a relevant technical discipline such as biology, chemistry, pharmaceutical sciences, biochemistry, biotechnology, molecular biology, chemical or bioengineering.
• Minimum 2 years of experience working in pharmaceutical/biotechnology industry.
• First-hand understanding/ experience with cell culture (preferably adherent mammalian culture) and composing/supplementing media required.
• Working experience in cleanroom (ISO 7 and
  5), fibroblast, primary tissue…