Manufacturing Associates I (Day & Second Shift)

Role Overview

We are seeking early-career Manufacturing Associate I candidates 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 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

• 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.
• Absorb and 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.

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, or chemical engineering.
• 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 while gowned for 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, with ability to follow established rules and quality standards.
• Communication Skills: Basic communication skills, with ability to understand instructions, ask questions when unclear, and report issues to supervisors or team leads.
• Documentation: Ability to complete required documentation accurately and legibly, with close supervision and review.
• Computer Skills: Basic ability to use computers and electronic systems for training, documentation, or data entry purposes.
• Cleanroom Practices: 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
• Teamwork: Ability to work effectively as part of a team, demonstrating reliability, cooperation, and respect for established processes.
• Flexibility: Ability to work a flexible schedule to support manufacturing operations, including overtime, weekend, and holiday work as business needs require.

Physical Demands

• While performing the duties of this Job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear. Fine motor skills include eye/hand coordination, flexibility and balance required. The employee must occasionally lift and/or move up to 30 pounds.

Working Conditions

• Office and Lab environment. While performing the duties of this Job, the employee is frequently exposed to toxic or caustic chemicals. This is an indoor position requiring the ability to perform experiments in the laboratory, and type and use a computer.
• May work in Cleanroom for an extended period of time.

Total Rewards and Culture

• Aspen Neuroscience, Inc., located in scenic Torrey Pines, is noted for its collaborative and learning focused culture where each person is valued for contributing their strengths and energy to building a world-class line of products for patients in need. The company offers a competitive total compensation package, time-off in addition to Company observed holidays, Medical/Dental insurance benefits, onsite gym, and other wellness perks.