Overview 

The Scientist will lead and support analytical development and assay qualification, and GXP early-stage assay development projects. This role requires relevant experience on analytical method development under the GMP and ICH guidelines. Proficient technical training in functional cellular and ligand binding potency assays. The scientist should have a working knowledge of cancer immunology and T cell activation. The scientist will be responsible for planning, documentation, execution and reporting to timely facilitate the analytical and process development goals. 

Specific Responsibilities

• Experience with cell based and immunology assays such as ELISA, cell-killing assays, multiplexed ligand binding assays (LBA) on Meso Scale Discovery and/or ELLA platforms.
• Provide scientific input for the design of cell-mediated immunoassays (CMI) regulated studies.
• Responsible for assay format selection based on risk assessment and fit-for-purpose.
• Responsible for method development, qualification/validation, troubleshooting and sample analysis as needed.
• Assess and implement new technologies for CMI assays.
• Serve as an internal subject matter expert on developed assays, providing technical support as needed to internal and external laboratories working to implement assays.
• Ensure assays are developed and executed in compliance with applicable Guidance and Regulations. Contribute to assay protocol and qualification/validation report preparation. Address quality assurance (QA) findings and observations.
• Contribute to regulatory filings pertaining to assay details as needed.
• Ability to independently analyze and interpret experimental data and to present and communicate results effectively to stake-holders and within a multi-disciplinary team environment
• Experience with multi-color flow cytometry analytical methods is required and familiarity with BD FACSLyric is preferred.
• Collaborate with Quality Control to enable effective assay transfer, enabling clinical product development and manufacturing required support.
• Provide technical leadership and scheduling for the team to ensure deliverables, coordination of external testing required and data collection. 
• Maintain up to date training and knowledge on automation and analytical tools/equipment. 
• Perform robust analysis and statistical evaluation of data for results-driven presentation and cross-functional discussion. 
• Contribute to scientific publications and to identification of patentable inventions 
• Maintain high level of professional expertise through regular consulting of scientific literature and attendance of training and/or scientific seminars. 

• Ensure compliance and maintenance of lab safety, environment, and quality. 

Education and Qualifications 

• PhD with 2 years of industry experience or Master’s degree with 5 years of industry in Immunology, Cellular, Molecular Biology field. 
• GMP or Quality experience with proficiency with regulatory compliance and FDA guidelines for Title 21 Code of Federal Regulations part 211 current Good Manufacturing Practices (cGMP) and Good Clinical (Research) Practices (GCP), ICH standards for analytical test methods as required. 
• Prior experience developing and supporting T cell and genome editing cell therapy product development. 
• Knowledge of medical terminology and intellectual capacity to use judgement and critical thinking skills to ensure that the data are accurate, logical, and consistent with internal and regulatory reporting requirements are required.
• Must be capable of working in fast-paced, collaborative environment and manage multiple concurrent projects with a high degree of independence. 
• Strong interpersonal, written, and oral communication skills are required. 
• Must be organized, be able to multi-task, and be a team player. 

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