Description:
Review protocols, testing, reports, and CoA/CoTs for release and stability of AAV based gene therapy products (e.g., qPCR, ddPCR, in-vitro based assays, ELISA, SDS-PAGE, HPLC, MS, and Western Blot)
Review QC Data
Help run method development, transfer and qualification/validation activities associated with the release of bacterial plasmids, viral vector products, critical reagents
Review QC data released from QC testing
Trend data for qualified materials, release products, and stability products.
Assist in writing and reviewing quality documents such as SOP, OOS/OOT, CAPA and Change Control
Author and review test methods, development reports, study protocols, and validation reports
Skills:Quality control, Agarose Gel Electrophoresis, Elisa, PCR, QC Data review, SDS page, Spectrophotometry Assay, Qc testing, AAV, Gmp, ddpcr, bacterial plasmid, Microbiology, cell culture, Data review, validation transfer, change control, Quality assurance, molecular biology, cell biology, virologyAdditional Skills & Qualifications:
BS. or M.S. degree in molecular biology, cell biology or virology with at least 5-8 years relevant experience
Experience with GMP
cell culture methods, polymerase chain reaction (PCR,) agarose gel electrophoresis, SDS-PAGE electrophoresis, ELISA, and spectrophotometric assays
Knowledge of compendial (USP, ICH, EP) guidance
Use of developing, validating, and deploying molecular biology test methods
Experience Level:Expert LevelAbout Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.