Job Description
We are seeking a Senior QC Scientist to support QC and assay development/qualification for the development of therapeutics in our biologics pipeline. This role involves establishing, qualifying, and conducting assays for product characterization and release/stability testing. It also includes maintaining assay-specific cell banks for cell-based assays and generating reference data for assay qualification and comparability assessments. The successful candidate will work within a GLP/GMP framework and participate in tech transfer of assays to the GMP manufacturing environment. Responsibilities also include hands-on performance of immunohistochemistry, PCR, flow cytometry, fibroblast proliferation, and ELISA-based assays, as well as cell and tissue culture, cell banking, and cell-based assay performance.
ResponsibilitiesDevelop, optimize, qualify, and transfer protein, immunologic, and nucleic acid-based assays to GMP manufacturing environment.Oversee validation for the biologics portfolio where appropriate.Demonstrate proficiency in molecular biology techniques such as sample preparation, nucleic acid amplification and purification (RNA/DNA) from biologically complex tissues, qPCR, and related techniques.Provide or oversee the provision of data reports necessary for completion of Certificate of Analysis to support lot release of biomanufactured products.Generate and communicate data for critical decision-making on experimental design, clinical study considerations, and overall corporate strategy.Perform and train others on appropriate documentation procedures to meet GXP Quality standards.Essential SkillsAssay development with 5+ years of experience.Cell assay development with 5+ years of experience.Proficiency in PCR, flow cytometry, and related techniques.Experience in a GXP environment is required.Additional Skills & QualificationsBS degree with 12-14 years, MS degree with 10-12 years, or Ph.D. with 6-8 years of relevant experience in the biopharmaceutical industry.Experience with assay development, qualification, and validation.Work Environment
The position is based in an onsite lab, providing a hands-on environment for conducting scientific research and development.
Pay and Benefits
The pay range for this position is $150000.00 - $180000.00/yr.
The company offers dental, vision, health benefits. Offers 401k, bonuses and PTO
Workplace Type
This is a fully onsite position in El Segundo,CA.
Application Deadline
This position is anticipated to close on Jun 30, 2025.
About 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.
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 due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.