Manufacturing Associate III (Day & Second Shift)

Valid8 Financial, Inc.; San Diego (CA); On-site; USD 50,000 - 54,000; Full time

Benefits offered by this job

Shift differential 10%

Job summary

Aspen Neuroscience is seeking an experienced Manufacturing Associate III to join our on-site Torrey Pines, CA operations, with a 12-hour Pitman shift schedule starting January 2027. The role requires 5+ years in pharmaceutical/biotech and strong mammalian cell culture expertise, with emphasis on GMP and SOP adherence.

In this role you will supervise, train, and support daily manufacturing activities, troubleshoot processes, manage documentation, and ensure product flow from cell culture to

Qualifications

• Bachelor’s or equivalent in biology, chemistry, pharma sciences, biochemistry, or related field.
• Minimum 5 years in pharma/biotech with mammalian cell culture experience.
• Trainer experience.
• Experience with cell culture operations and scheduling activities.

Responsibilities

• Manufacture clinical cell therapy products in GMP-cleanroom environment.
• Oversee setup and operation of automated cell culture systems per SOPs.
• Develop SME knowledge for assigned processes and equipment.
• Execute manufacturing operations including inventory, move orders, and production of intermediates and finished goods.
• Lead work coordination and task prioritization to maintain continuous product flow.
• Instruct and train associates on SOPs, equipment operation, and GMP expectations.
• Review logs and batch records for accuracy and completeness.
• Troubleshoot routine manufacturing issues and collaborate with partners for resolution.
• Support testing and release of raw materials and reagents with Quality Control.
• Write and revise SOPs, batch records, and quality documents.

Skills

Cell culture

Training

Scheduling

GMP knowledge

Documentation

Education

Bachelor's degree or equivalent

Job description

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 TorreyPines,CA. Relocation is not available.

Role Overview:We are seekingManufacturing Associate IIIcandidateswith a minimumof5 years of experience working in pharmaceutical/biotechnology industry with first-hand understanding of mammalian cell culture.

Key Focus Areas:This role is assignedto amanufacturing supervisor and directs, assists, instructs, and reviews the daily work in the designated Manufacturing area.This includes all activities associated with cell-relatedfunctions;including producing cells and intermediate products related to induced pluripotent stem cells (iPSC) derived dopaminergic progenitor cells. This roleis responsible forensuring the approved procedures and protocols arefollowedperSOP.

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) andSecondShift (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- Saturdaymaintainingthe same work time until transitioning to 12- hour shift in January 2027.

DUTIES AND RESPONSIBILITIES:

• Manufactureclinical cell therapy products in aGMP‑controlledcleanroom environment, performing manual and automated cell culture activitiesin accordance withapproved procedures and quality standards.
• Perform and provide oversight support for the setup, operation, and breakdown of automated cell culture systems, ensuringaccurateconfiguration and adherence toestablishedprotocols.
• Develop and expand operationalproficiencywith the goal of serving as a knowledgeableresource(SME)for assigned manufacturing processes, equipment, or techniques.
• Execute all manufacturing operations, including inventory management, move orders, and the production ofintermediatesand finished goods across all manufacturingstages.
• Support daily manufacturing operations byassistingleads and management with work coordination, including task distribution and prioritization tomaintaincontinuous product flow.
• Assistwith routinefloor‑leveloperational 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, asappropriate torole and experience level.
• Monitor and mentor newly trained associates in established areas ofproficiency, 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, andassistassociates with training or documentation questions as needed.
• Troubleshoot routine manufacturing process issues and product challenges, collaborating with internal and external partners to supporttimelyand compliantresolution.
• Support testing and release of raw materials and new reagent lots, including participation in comparative evaluations of alternate materials in collaboration with Quality Control.
• Assistmanagement 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.
• Performdeviation investigations, write impact assessments, CAPAs, NCMRs, and OOS documentation bygathering information and completing assigned actions.
• Adhere to company policies, GMP requirements, and safety standards whilemaintainingconsistent 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 disciplinesuch 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 supplementingmedia, cleanroom (ISO 7 and 5), (automation, fibroblast, primary tissue culture, and iPSC cells a plus).Equivalentcombination of knowledge and experience will be considered.
• Trainerexperience.
• Experiencewithcellcultureoperationsandfamiliaritywithexecutionand troubleshooting of moderate to complex scheduling activities isa 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:Demonstratedability to perform manual and automated cell culture techniquesin accordance withapproved 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 ortask‑trackingtools to support daily operations and documentation.
• GMP & Aseptic Practices:Knowledge of GMP principles, aseptic processing techniques, cleanroom operations, safety practices, andrequiredocumentation practices.
• Collaboration:Ability to work effectively within across‑functionalteam environment to support manufacturing activities and qualityobjectives.
• Flexibility:Ability toworka flexible schedule, including overtime, weekend, and holiday work, based on manufacturing and business needs.
• Technical Writing:Ability to completeaccurateand compliant documentation, including reports, SOPs, batch records (BRs), andquality‑relateddocuments with guidance.

WORKING CONDITIONS

Office and Lab environment. While performing the duties of this Job, the employee isfrequentlyexposed 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 inCleanroomfor an extendedperiod of time.

PHYSICAL DEMANDS

While performing the duties of this Job, the employeeis regularly required tostand; 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, depthperceptionand ability to adjust focus.

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, depthperceptionand ability to adjust focus.

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.Aspenis not able toprovide 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.,locatedin 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 Companyobservedholidays, Medical/Dental insurance benefits, onsite gym, and other wellnessperks.

Theanticipatedsalary range for candidates who will workin San Diego is$36.00-$39.00hourlywith 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.