Manufacturing Associates II (Day & 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 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. 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 (5:00 am – 5:00 pm) and the Second Shift (11:30 am – 11:30 pm). 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

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.

EDUCATION AND EXPERIENCE

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

JOB SPECIFICATIONS

CMC Awareness: Basic understanding of CMC development and manufacturing concepts, with the ability to follow established procedures in a GMP manufacturing environment. Cell Culture Skills: Ability to perform routine manual and automated cell culture activities in accordance with approved protocols, GMP requirements, and quality standards, with supervision. Regulatory Understanding: Foundational knowledge of GMP principles and awareness of ISO standards, Quality Systems, and FDA regulations applicable to manufacturing operations. Communication Skills: 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. Technical Skills: Basic computer skills, including use of Microsoft Office and other systems required for documentation and data entry. GMP & Aseptic Practices: 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. Collaboration: Ability to work effectively as a member of a manufacturing team and coordinate with others to support assigned tasks and team objectives. Documentation: Ability to complete batch records, logs, and other manufacturing documentation accurately and in compliance with GMP expectations, with guidance as needed. Flexibility: Ability to work a flexible schedule to support manufacturing operations, including overtime, weekend, and holiday work as business needs require.

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.

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 are required. Employees must be able to gown and work in cleanroom environment. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision (especially the ability to distinguish different hues/shades of purple, red, pink, orange and yellow), peripheral vision, depth perception and ability to adjust focus. These work environmental characteristics are representative of the environment the job holder will encounter. Reasonable accommodation may be made to enable people with disabilities to perform the essential functions of the job. EEO and Employment Eligibility Aspen Neuroscience is committed to providing equal employment opportunities to all employees and job applicants and prohibits discrimination and harassment of any type. We are committed to creating an inclusive environment for all employees. Aspen Neuroscience is not able to provide visa sponsorship for this role. Applicants must have valid work authorization that does not require employer sponsorship now or in the future. 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. The anticipated hourly range for candidates who will work in San Diego is $30–$33 hourly with a shift differential of 10% provided for the Second Shift. The final hourly rate offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc. Aspen Neuroscience is multi‑state employer, and this salary range may not reflect positions that work in other states. #J-18808-Ljbffr Valid8 Financial, Inc.