Manufacturing Associate I (Day & Second Shift)

Valid8 Financial, Inc.; San Diego (CA); On-site; USD 37,000 - 47,000; Full time

Benefits offered by this job

Medical/Dental insurance

Onsite gym

Paid time off

Job summary

Aspen Neuroscience is expanding its team to support clinical production with a new shift schedule beginning in 2027. This on-site role is in Torrey Pines, CA, relocation not available. We seek early-career Manufacturing Associate I candidates interested in biotech and clinical cell therapy manufacturing.

The role involves producing cells and intermediate products related to fibroblasts, iPSCs, and dopaminergic progenitor cells, with 12-hour shifts on a 2-2-3 Pitman schedule.

Qualifications

• Associate degree or higher in biotechnology or related field, or equivalent industry experience.
• Experience in pharmaceutical/biotechnology industry with cell culture knowledge preferred.
• Willingness to work 12-hour shifts in a GMP cleanroom.
• Ability to follow SOPs, batch records, and controlled documents.

Responsibilities

• Perform manufacturing tasks for clinical cell therapy products in 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.

Skills

GMP knowledge

Cleanroom experience

Cell culture

Documentation

Education

Associate degree or higher in biotech

Biotech program certificate

Job description

Aspen Neuroscience is expanding its team to support clinical productionwith 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 seeking early-careerManufacturing Associate Icandidates 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 shiftsrotatingon a 2-2-3 “Pitman” Schedule.

The two shifts available are the DayShift (5:00am – 5:00pm)andSecondShift (11:30am – 11:30pm.)

Training Period:From Date of Hire until completion of training program,newhires will work M-F (7:00-3:30)pm.Upon training completion, employeeswill transition to Sunday-Thursday or Tuesday- Saturdaymaintainingthe same work time until transitioning to 12-hour shift in January 2027.

DutiesAnd Responsibilities:

Perform manufacturing tasks for clinical cell therapy products in aGMP‑controlledcleanroom 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.

Assistwith the setup, operation, and breakdown of automated cell culture systems to support manufacturing activitiesin accordance withestablished 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 wellasstitingwith inventory tracking and cycle counts.

Work collaboratively as a member of the manufacturing team and interact withcross‑functionalpartners to support clinical manufacturing operations.

Accurately complete manufacturing documentation, including batch records, logs, and forms,in accordance withGMP requirements, with review by others asrequired.

Assistwith 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 manufacturingeventsunder supervision.

Promptly report process issues, equipment concerns, or conflicts to the Lead, Supervisor, or Manager.

Adhere to company policies, GMP requirements, and safety standards whilemaintaininga high levelof 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, orchemicalengineering.

Some experienceworking 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 whilegownedfor 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, withabilityto 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 teamleads.

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 afterappropriate training.Due toGxPrequirements, 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,demonstratingreliability, cooperation, and respect for established processes.

Flexibility:Ability toworka 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 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 in Cleanroom for 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.Fine motor skills include eye/hand coordination,flexibilityand balancerequired.The employee must occasionally lift and/or move up to30pounds.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.

These work environment characteristics are representative of the environment the job holder willencounter. Reasonable accommodations 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.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 acompetitive total compensation package, time-off in addition to Companyobservedholidays, Medical/Dental insurance benefits, onsite gym, and other wellnessperks.

Theanticipatedpayrange for candidates who will work in San Diego is$27.40-$33.65withashift differentialof 10% provided for theSecond Shift.The finalpayoffered 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.