Manufacturing Associate III (Day & Second Shift)

Manufacturing Associate III

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 III candidates with a minimum of 5 years of experience working in pharmaceutical/biotechnology industry with first-hand understanding of mammalian cell culture.

Key Focus Areas

This role is assigned to a manufacturing supervisor and directs, assists, instructs, and reviews the daily work in the designated Manufacturing area. This includes all activities associated with cell-related functions; including producing cells and intermediate products related to induced pluripotent stem cells (iPSC) derived dopaminergic progenitor cells. This role is responsible for ensuring the approved procedures and protocols are followed per SOP.

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

Manufacture clinical cell therapy products in a GMP-controlled cleanroom environment, performing manual and automated cell culture activities in accordance with approved procedures and quality standards.

Perform and provide oversight support for the setup, operation, and breakdown of automated cell culture systems, ensuring accurate configuration and adherence to established protocols.

Develop and expand operational proficiency with the goal of serving as a knowledgeable resource (SME) for assigned manufacturing processes, equipment, or techniques.

Execute all manufacturing operations, including inventory management, move orders, and the production of intermediates and finished goods across all manufacturing stages.

Support daily manufacturing operations by assisting leads and management with work coordination, including task distribution and prioritization to maintain continuous product flow.

Assist with routine floor-level operational decisions, such as activity prioritization and break coverage, when Lead or Management are unavailable.

Instruct and train manufacturing associates on job procedures, equipment operation, safety practices, and GMP expectations, as appropriate to role and experience level.

Monitor and mentor newly trained associates in established areas of proficiency, providing feedback and support to promote independent task execution and quality performance.

Maintain manufacturing and process development equipment and inventory, including support of material readiness and Kanban processes.

Review daily manufacturing logs, batch records, and documentation for accuracy and completeness, and assist associates with training or documentation questions as needed.

Troubleshoot routine manufacturing process issues and product challenges, collaborating with internal and external partners to support timely and compliant resolution.

Support testing and release of raw materials and new reagent lots, including participation in comparative evaluations of alternate materials in collaboration with Quality Control.

Assist management with documentation review, ERP activities (inventory, equipment maintenance, and supply orders), data trending, and participation in meetings as a SME.

Write, review, and revise SOPs, batch records, and quality documents, ensuring accuracy and compliance with GMP requirements.

Perform deviation investigations, write impact assessments, CAPAs, NCMRs, and OOS documentation by gathering information and completing assigned actions.

Adhere to company policies, GMP requirements, and safety standards while maintaining consistent quality and compliance performance.

Perform other assigned duties consistent with role scope and training.

Education and Experience

Bachelor's, or equivalent industry experience in a relevant technical discipline such as biology, chemistry, pharmaceutical sciences, biochemistry, molecular biology, chemical engineering or equivalent.

Minimum 5 years of experience working in pharmaceutical/biotechnology industry with first-hand understanding of mammalian cell culture, composing and supplementing media, cleanroom (ISO 7 and 5), (automation, fibroblast, primary tissue culture, and iPSC cells a plus). Equivalent combination of knowledge and experience will be considered.

Trainer experience.

Experience with cell culture operations and familiarity with execution and troubleshooting of moderate to complex scheduling activities is a must.

Job Specifications

CMC Knowledge: Working knowledge of CMC development and manufacturing concepts, with the ability to apply established procedures within GMP manufacturing environments.

Cell Culture Skills: Demonstrated ability to perform manual and automated cell culture techniques in accordance with approved protocols, GMP requirements, and quality standards.

Regulatory Awareness: Working knowledge of ISO standards, Quality Systems, and FDA regulations applicable to regulated manufacturing operations.

Communication Skills: Effective oral and written communication skills, with the ability to follow instructions, document work accurately, and communicate clearly with team members.

Technical Skills: Proficient computer skills, including the use of Microsoft Office and basic project or task-tracking tools to support daily operations and documentation.

GMP & Aseptic Practices: Knowledge of GMP principles, aseptic processing techniques, cleanroom operations, safety practices, and required documentation practices.

Collaboration: Ability to work effectively within a cross-functional team environment to support manufacturing activities and quality objectives.

Flexibility: Ability to work a flexible schedule, including overtime, weekend, and holiday work, based on manufacturing and business needs.

Technical Writing: Ability to complete accurate and compliant documentation, including reports, SOPs, batch records (BRs), and quality-related documents with guidance.

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. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, 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 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 salary range for candidates who will work in San Diego is $36.00-$39.00 hourly with a shift differential of 10% provided for the Second Shift. The final salary 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.