Manufacturing Associates I (Day & Second Shift)

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

About the role

We are seeking early-career Manufacturing Associate I candidates who are interested in 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.

Schedule

Beginning January 2027, Associates will work 12-hour shifts rotating on a 2-2-3 “Pitman” Schedule. The two shifts available are:

• Day Shift: 5:00am – 5:00pm
• Second Shift: 11:30am – 11:30pm (includes a 10% shift differential)

Training Period: From date of hire until completion of training program, new hires will work Monday–Friday (7:00am–3:30pm). Upon training completion, employees will transition to either Sunday–Thursday or Tuesday–Saturday, maintaining the same work time until transitioning to the 12-hour shift in January 2027.

Responsibilities

• Perform manufacturing tasks for clinical cell therapy products in a GMP-controlled cleanroom 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 well as assisting with inventory tracking and cycle counts.
• Work collaboratively as a member of the manufacturing team and interact with cross-functional partners to support clinical manufacturing operations.
• Accurately complete manufacturing documentation, including batch records, logs, and forms, in accordance with GMP 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 manufacturing events under supervision.
• Promptly report process issues, equipment concerns, or conflicts to the Lead, Supervisor, or Manager.
• Adhere to company policies, GMP requirements, and safety standards while maintaining a high level of quality and compliance.
• Perform other assigned duties consistent with training and role level.

Requirements

• Associate degree or higher, a Biotech Program certificate from an accredited college, or equivalent industry experience in a relevant technical discipline (e.g., biology, chemistry, pharmaceutical sciences, biochemistry, biotechnology, molecular biology, or chemical engineering).
• Some experience working in the pharmaceutical/biotechnology industry with understanding of mammalian cell culture, media composition, cleanroom environments (ISO 7 and 5), and related processes (automation, fibroblast, primary tissue culture, and iPSC cells a plus).
• Introductory knowledge of manufacturing concepts and regulated environments, with willingness and ability to learn GMP requirements, including working in a cleanroom environment while gowned for extended periods.
• Ability to perform assigned manufacturing tasks after training, following detailed instructions, standard operating procedures, and safety guidelines.
• Basic awareness of GMP principles and cleanroom expectations, with ability to follow established rules and quality standards.
• Basic communication skills, with ability to understand instructions, ask questions when unclear, and report issues to supervisors or team leads.
• Ability to complete required documentation accurately and legibly, with close supervision and review.
• Basic computer skills for training, documentation, or data entry purposes.
• Ability to follow cleanroom procedures, aseptic practices, and safety requirements after appropriate training.
• Due to GxP requirements, employees may not smoke during scheduled work hours; nicotine patches or other cessation aids are acceptable.
• Ability to work effectively as part of a team, demonstrating reliability, cooperation, and respect for established processes.
• Flexibility to work a variable schedule to support manufacturing operations, including overtime, weekends, and holidays as business needs require.

Working Conditions

• Office and lab environment with frequent exposure to toxic or caustic chemicals.
• Indoor position requiring the ability to perform experiments in the laboratory, type, and use a computer.
• May work in a cleanroom for extended periods of time.

Physical Demands

• Regularly required to stand, walk, sit, use hands to finger/handle/feel, reach with hands and arms, and talk or hear.
• Fine motor skills include eye/hand coordination, flexibility, and balance.
• Occasionally lift and/or move up to 30 pounds.
• Specific vision abilities required include close vision, distance vision, color vision (especially distinguishing hues/shades of purple, red, pink, orange, and yellow), peripheral vision, depth perception, and ability to adjust focus.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job.

Pay

The anticipated pay range for candidates who will work in San Diego is $27.40 - $33.65 per hour. The final pay offered to a successful candidate will depend on several factors, including type and length of experience within the industry, education, and other relevant qualifications. Aspen Neuroscience is a multi-state employer, and this salary range may not reflect positions in other states.

Benefits

• Competitive total compensation package.
• Paid time off in addition to company-observed holidays.
• Medical and dental insurance benefits.
• Onsite gym and other wellness perks.

Aspen Neuroscience is noted for its collaborative and learning-focused culture where each person is valued for contributing their strengths and energy to building world-class products for patients in need.