Director of Analytical Development

Proclinical is seeking a Director of Analytical Development located in Tampa, Florida with a biotech company. In this role, you will lead projects that focus on the development, qualification, and validation of analytical assays for the characterization and release of TIL therapy products for Clinical Trials and Commercial supply.

Job Responsibilities:

• Lead a team of scientists developing cutting-edge competitive technology and analytical platforms for the characterization of TIL drug product.
• Develop and implement analytical methods for the characterization of anti-tumor activity for therapeutic application including co-stimulatory and co-inhibitory pathways, T cell selection strategies, proliferation and expansion, re-programming, and cytotoxicity assays.
• Drive analytical testing support for down-stream and late-stage process development and assist in the development and analytical characterization for improved manufacturing process steps.
• Work closely with partner CMOs and partner laboratories for qualification and validation of analytical methods in-line with current ICH guidelines and evaluate CRO/CMO test results and write summary reports of the results when necessary.
• Support analytical testing for both formulation development as well as methods for the release and stability assessment.
• Lead development studies and the qualification of assays providing scientific and technical leadership and overseeing scheduling for the team to ensure deliverables, coordination of external testing and data collection.
• Train new and junior Associates/Scientists in experimental design, troubleshooting, and serve as a techniques master, training supervisor, and SME for scientific rational for the discrimination of tumor immunology for Analytical Development.
• Reliably implement, troubleshoot, and perform analysis of cellular biology techniques including: immunophenotyping, metabolic profiling, ligand-binding, cytotoxicity, cytokine secretion profiling and therapeutic potency.
• Offer technical subject matter expertise for the advisement on development and risk assessment for failure of assay protocol and design of experiment including: protocol review, development/revision of BR, SOPs, DFP and CAPA investigations.
• Maintain up to date training and knowledge on automation and analytical tools/equipment to advise on top-level innovation for analysis.
• Perform robust analysis and statistical evaluation of data for results-driven presentation and multi-department discussion.
• Author protocols and associated reports per Good Documentation Practices (GDP).
• Contribute to scientific publications.
• Help identify 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.

Skills and Requirements:

• PhD with 10+ years of industry experience in the 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.
• Extensive tissue culture experience using primary and established cell lines, in vitro T-cell functional assays, subject matter expert in flow cytometry staining and acquisition techniques, immunoassays, optimization, and analysis.
• Prior experience developing and supporting the development of cell therapy.
• 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.

If you are having difficulty in applying or if you have any questions, please contact Celie Mans at (+1) 424-361-3907 or c.mans@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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