Manufacturing Associates ; Second Shift

Manufacturing Associate I

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 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.
• 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…