Associate Director, Biologics Analytical Development

Proclinical is currently recruiting for an Associate Director of Analytical Development with a leading biopharmaceutical company located in Tampa, FL. As the Associate Director, you will be responsible for leading the development of innovative analytical methodologies to enable the development of a novel protein-conjugate/monoclonal antibody drug products and TIL therapy.

Job Responsibilities:

• 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.
• Develop and implement analytical methods utilized for both formulation development as well as methods for the release and stability assessment.
• Author/Review Development and Qualification reports, protocols, SOPs and Validation reports.
• Evaluate CRO/CMO test results and write summary reports of the results when necessary.
• Analyze and interpret results and methods, troubleshoot processes and analytical methodologies, generate solutions to problems and meet related regulatory requirements.
• Utilize knowledge and experience in both bioanalytical assays and protein chemistry to advise on analysis including flow cytometry, chromatography and capillary electrophoresis to contribute to the development of pipeline clinical stage oncology biotherapeutics.
• 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 training is up to date on new processes and analytical methods.
• Ensure compliance and maintenance of lab safety, environment, and quality.

Skills and Requirements:

• PhD with 8+ years of industry experience in Chemistry and or Molecular Biology field.
• Possess a solid understanding of protein chemistry and biochemistry particularly as it relates to biotherapeutic protein drug development, protein stability and concentration of protein formulations.
• Experience with CMC analytical development of monoclonal antibodies or related biotherapeutic proteins is preferred.
• Quality control and or GMP experience is required.
• Proficiency in regulations and guideline documents (cGMP / ICH / pharmacopeia) required.
• Prior experience developing and supporting cell therapy manufacturing processes desirable.
• Immunology and / or oncology research background preferred.
• Ability to apply critical thinking skills to evaluate requirements and effectively communicate (written and oral) findings.
• Must be capable of working in fast-paced, collaborative environment and manage multiple concurrent projects with a high degree of independence.
• Demonstrated communication, problem-solving, leadership, and negotiation/decision-making skills
• 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 Max Robinson at (+1) 617-903-7746 or m.robinson@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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