Associate Scientist, Quality Control

Associate Scientist, Quality Control – Analytical Development

The Associate Scientist, Quality Control will support the Analytical Development team in developing, optimizing, implementing, and supporting robust analytical methods that enable a deep understanding of cell therapy products and processes. In this role, you will execute analytical operations that contribute to the development and qualification of critical assays, provide analytical support for process development and cGMP manufacturing activities, and help ensure CMC readiness for early and late phase clinical assets.

You will work extensively at the bench with bioanalytical and cell-based assays, collaborate with cross-functional teams, and apply your experience in cell therapy, CAR-T, and bioanalytical techniques in a fast-paced, highly regulated environment.

Responsibilities

• Support all aspects of assay lifecycle management for bioanalytical and cell-based assays, including development, optimization, qualification, and transfer.
• Independently design and execute experimental protocols in support of analytical development activities.
• Provide analytical support for cell therapy manufacturing process development and characterization activities.
• Perform routine characterization testing on in-process, final product, and stability samples according to established SOPs in support of clinical trials.
• Perform cell culturing and maintenance of human and non-human mammalian cell lines.
• Maintain aseptic technique while working within a biosafety cabinet in a BSL-2 environment.
• Properly record and report all generated data in accordance with current Good Documentation Practices.
• Review data recorded by peers for accuracy, completeness, and adherence to current Good Documentation Practices.
• Effectively communicate experimental data, interpretations, and conclusions to peers, department leadership, and cross-functional teams within Technical Operations.
• Perform daily, weekly, and monthly maintenance on laboratory equipment and analytical instruments.
• Prepare, operate, and maintain delicate analytical instruments used in bioanalytical and cell-based assays.
• Prepare, analyze, and properly discard biological samples and materials in compliance with safety and environmental requirements.
• Maintain a clean, organized, and safe working environment in the laboratory.
• Maintain an understanding of applicable regulatory guidelines for assay development, implementation, qualification, and CMC readiness.
• Adhere strictly to company policies, rules, regulations, and safety procedures while handling hazardous chemicals and substances.
• Contribute to cross-functional project teams by representing the interests and needs of the Analytical Development group.
• Manage priorities and timelines effectively to meet key departmental deliverables and project milestones.

Essential Skills

• Bachelor's degree and 4+ years of experience, or Master's degree and 2+ years of experience in cell and molecular biology, immunology, biochemistry, or another relevant life science field.
• At least 2+ years of biotech industry experience, with a preference for experience in cell therapeutics.
• Hands-on experience with flow cytometry (FACS) for cell therapy or related applications.
• Proficiency with ELISA and other immunoassay-based bioanalytical techniques.
• Experience with cell-based potency assays such as IFN-γ release assays and direct cell killing measurements.
• Experience with metabolic function assays, including platforms such as Seahorse, MTT assay, and MetaFLEX.
• Experience performing qPCR for analytical or characterization purposes.
• Experience with image-based cell counting methods and instruments.
• Demonstrated ability to culture and maintain human and non-human mammalian cell lines.
• Strong aseptic technique and experience working within a biosafety cabinet in a BSL-2 laboratory.
• Experience with assay development and optimization for cell therapy or related applications.
• Familiarity with release testing and quality control activities for biologics or cell therapy products.
• Strong technical writing skills for documenting methods, results, and reports.
• Effective data presentation skills, including the ability to…