cGMP Process Development (PD) Specialized Laboratory Technician jobs in United States
cer-icon
Apply on Employer Site
company-logo

University of Southern California · 2 months ago

cGMP Process Development (PD) Specialized Laboratory Technician

The University of Southern California (USC) is a prestigious research university located in downtown L.A. They are seeking a cGMP Process Development (PD) Specialized Laboratory Technician to support the development and manufacturing of cell and gene therapies. The role involves conducting laboratory experiments, maintaining equipment, and ensuring compliance with cGMP guidelines while assisting in process optimization.

EducationHigher EducationUniversities
check
Growth Opportunities
check
H1B Sponsor Likelynote

Responsibilities

Performs moderate to complex laboratory procedures related to cell therapy development
Utilizes specialized techniques and technology to achieve results (e.g., media preparation, cell expansion, harvesting, cryopreservation, and cell culture) and conducts quality control testing to ensure product safety, purity, and compliance, utilizing methods such as sterility testing, endotoxin assessment, mycoplasma detection, and flow cytometry
Supports cGMP manufacturing activities by performing aseptic techniques in a fully gowned cleanroom environment
Assists in executing laboratory experiments related to process development (e.g., preparing, operating, cleaning equipment)
Performs routine quality control tests and assays on materials, products, and processes to ensure compliance with standards
Conducts environmental monitoring in cGMP cleanrooms (e.g., viable and non-viable particulate monitoring and surface sampling)
Follows established SOPs and adheres to regulatory guidelines, ensuring compliance with cGMP and safety protocols
Maintains awareness of emerging laws, regulations, industry best practices, and advancements in cell therapy and cGMP manufacturing
Prepares, calibrates, and maintains laboratory equipment for use
Participates in routine lab maintenance and ensures a clean, safe, and organized working environment across all departments
Monitors inventory of lab supplies and materials, ensuring sufficient stock for ongoing operations and timely ordering
Collects, documents, and records data accurately, maintaining detailed and organized electronic records
Assists with technology transfer activities, ensuring smooth transition of processes between development and manufacturing
Supports process optimization efforts by gathering and analyzing data from experiments and production runs
Stays up to date with the latest advancements, regulations, and best practices in cell therapy and cGMP manufacturing
Engages in professional development and training to enhance skills and ensure compliance with evolving industry standards
Promotes an environment that fosters inclusive relationships and creates unbiased opportunities for contributions through ideas, words, and actions that uphold principles of the USC Code of Ethics
Performs other related duties as assigned or requested

Qualification

CGMP complianceCell therapy developmentLaboratory equipment maintenanceQuality control testingRegulatory knowledgeTroubleshooting skillsCommunicationTeamwork skillsAttention to detail

Required

Degree in a directly related specialized scientific field
Demonstrated knowledge of all aspects of biotechnology and cell therapy
Demonstrated passion for solving complex scientific issues
Experience with Food and Drug Administration regulations and clinical trials
Strong communication and writing skills with demonstrated ability to work as an individual contributor and in a dynamic team environment
Bachelor's degree in Biological Science And/Or Biotechnology
2 years in cell therapy development
Proficiency in operating and maintaining laboratory equipment used in cGMP manufacturing and quality control testing
Strong attention to detail and ability to follow standard operating procedures (SOPs) and quality assurance principles meticulously
Excellent communication and teamwork skills to collaborate effectively with cross-functional teams
Ability to troubleshoot and resolve technical issues in a timely manner
Knowledge of regulatory requirements and guidelines (e.g., FDA, EMA) related to cGMP

Preferred

Master's degree
3 years in cell therapy development

Company

University of Southern California

company-logo
University of Southern California is a private research university offering opportunities for interdisciplinary study and collaboration.

H1B Sponsorship

University of Southern California has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (253)
2024 (239)
2023 (172)
2022 (207)
2021 (182)
2020 (195)

Funding

Current Stage
Late Stage
Total Funding
$19.64M
Key Investors
Patient-Centered Outcomes Research InstituteCalifornia Institute for Regenerative MedicineCDA Foundation
2025-02-04Grant· $10.8M
2025-01-30Grant· $5.93M
2024-07-30Grant

Leadership Team

leader-logo
David A Barnhart
Director, USC Space Engineering Research Center
linkedin
H
Hossein Pourmand
Assistant Vice President, Research Initiatives, University Advancement
linkedin
Company data provided by crunchbase