Manufacturing Associate ; 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 early-career

Manufacturing Associate Icandidates who are interested in 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 shiftsrotatingon 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,newhires 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.

Duties And Responsibilities:

Perform manufacturing tasks for clinical cell therapy products in aGMP‑controlledcleanroom environment by following approved procedures, work instructions, and safety standards.

Execute routine manual and automated cell culture activities, including cell expansion, feeding, passaging, harvesting, counting, freezing, seeding, labeling, and operation of laboratory equipment, following training and supervision.

Assist with the setup, operation, and breakdown of automated cell culture systems to support manufacturing activities in accordance with established protocols.

Participate in required training and qualification activities, including gowning, aseptic technique, equipment and facility qualifications, and aseptic process simulations.

Support inventory and material handling activities, including wiping, staging, and moving materials into training, controlled, and cleanroom areas, as wellasstitingwith inventory tracking and cycle counts.

Work collaboratively as a member of the manufacturing team and interact withcross‑functional partners to support clinical manufacturing operations.

Accurately complete manufacturing documentation, including batch records, logs, and forms,in accordance withGMP requirements, with review by others as required.

Assist with the preparation, review, or routing of quality and manufacturing documents, including SOPs, batch records, labels, and controlled documents, under guidance.

Support deviation and investigation activities by providing information or documentation related to manufacturingeventsunder supervision.

Promptly report process issues, equipment concerns, or conflicts to the Lead, Supervisor, or Manager.

Adhere to company policies, GMP requirements, and safety standards whilemaintaininga high levelof quality and compliance.

Perform other assigned duties consistent with training and role level.

Education And Experience:

Associate degree or higher, 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, orchemicalengineering.

Some experience working in pharmaceutical/biotechnology industry with understanding of mammalian cell culture, composing and supplementing media, cleanroom (ISO 7 and
5), (automation,fibroblast, primary tissue culture, and iPSC cells a plus), is preferred.

Job Specifications:

Manufacturing Knowledge:

Introductory knowledge of manufacturing concepts and regulated environments, with willingness and ability to learn GMP requirements; including working in a cleanroom environment whilegownedfor an extended period.

Technical Aptitude:

Ability to perform assigned manufacturing tasks after training, following detailed instructions, standard operating procedures, and safety guidelines.

Regulatory Awareness:

Basic awareness of GMP principles and cleanroom expectations, withabilityto follow established rules and quality standards.

Communication

Skills:

Basic communication skills, with ability to understand instructions, ask questions…