Quality Control Associate - Cell Therapy

Description:

We are seeking a highly motivated Quality Control Associate to join our team reporting to the Senior Quality Control Associate. In this role, you will perform and evaluate the analytical quality control testing studies to support assay characterization and qualification and Phase 1 manufacturing for cell therapy - collaborating with internal partners and external CMOs / CROs.

Responsibilities:

Execution of complex biological assays with high technology instrumentation per SOPs

● Perform hands-on laboratory testing utilizing various analytical techniques including PCR, flow cytometry, cell counting, and cytotoxicity assays in support of cGMP clinical manufacturing.

● Perform cell culture work to support cGMP clinical manufacturing.

● Perform statistical and analytical analysis of experiments as appropriate to ensure analytical assay trending and control; contribute to data packages for regulatory agencies, presentations, and publications.

● Write and revise SOPs and technical / summary reports with some supervision.

Execution of QC assay studies or qualifications to meet laboratory GMP requirements under supervision

● Support analytical technology transfer from Research and Process Development to Quality Control.

● Perform and document quality investigations to support out-of-specification results and data summaries.

General QC laboratory maintenance and EH&S

● Operate, qualify, and maintain equipment within the Quality Control laboratory.

● Follow all Quality standards and environmental health and safety guidelines.

● Support setup and implementation of a Quality Control Laboratory.

Continuous improvement of Assay procedures

● Author continuous improvement of Assay procedures under supervision

Work cross-functionally with Preclinical Discovery, Translational Sciences, Clinical Development, Clinical Operations, Biometrics, Regulatory and Safety to execute on corporate goals.

Must be available to work weekend shifts and extended shifts as necessary.

Skills:

Mammalian cell culture, ddPCR, flow cytometry, cGMP, cell therapy, t-cell, mollecular, assay, cell culture, mobile assay, sop revision, method development, sop writing, method writing, cellular assay, cell based assay, potency assay, cytotoxicity, cell line, qc analytical, gene therapy, micro pipetting, quality, qc, cryopreservation, dd PCR

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.

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 for other accommodation options.