Manufacturing Associates II (Day & Second Shift)

Aspen Neuroscience•San Diego, CA

6h•$30 - $33•Onsite

About The Position

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

Requirements

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.
Basic understanding of CMC development and manufacturing concepts, with the ability to follow 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.

Nice To Haves

Working experience in cleanroom (ISO 7 and 5), fibroblast, primary tissue culture, and iPSC cells preferred.
Some trainer experience preferred.

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.