Associate Director Analytical Development

Proclinical is currently recruiting for an Associate Director of Analytical Development with a global biopharmaceutical company located in New York, NY. As the Associate Director, you will be responsible for managing the analytical aspect of portfolio projects with the responsibilities to serve as an analytical subject matter expert and to oversee the timely delivery of analytical methods and data analysis .

Job Responsibilities:

• Manage the development, validation and implementation of appropriate analytical methods at CDMOs and CROs in support of API drug substance and solid dose drug product in pre-clinical and clinical programs with focus on analytical methods for process development, process controls, impurity controls, API and drug product characterization.
• Provide technical oversight of outsourced analytical activities to enable timely delivery of supplies for portfolio programs.
• Analyze results, solve analytical issues, and meet regulatory expectations for analytics applied to small molecule drug substances and drug products.
• Author, review and approve change controls, deviations, CAPAs, and risk assessments.
• Review and approve analytical documents such as analytical method development report, feasibility study, qualification protocol, validation protocol, transfer protocol, validation report, method of analysis, and laboratory investigation report.
• Provide on-site presence at CDMOs for audit, training, meetings as needed to achieve objectives.
• Manage tracking of analytical reference standards and impurities.
• Oversee stability studies for drug substances and drug products to support shelf-life.
• In collaboration with regulatory, author relevant Chemistry, Manufacturing and Controls (CMC) sections for drug substances and address Regulatory reviewer comments with data supporting responses to enable accurate and timely registrational submission.
• Flexibility to travel up to 20% domestic/international (post-COVID).

Skills and Requirements:

• PhD or MS in Chemistry with 10+ years of related pharmaceutical development experience.
• In-depth working knowledge of analytical techniques, analytical method development, method transfer, method validation and stability.
• Knowledge in biologic analytical methods is a plus.
• Ability to understand complex processes, identify knowledge gaps and propose efficient and effective solutions to issues.
• Experience in regulatory filings, specifications and controls, analytical method development and validation and the commercialization process.
• Knowledgeable of ICH guidelines and FDA Guidance related to Pharmaceutical development, validation, manufacturing and stability of drug substance and drug product.
• Experience in actively managing outsourcing to contract development and manufacturing organizations.
• Ability to work independently in a cross-functional team environment.
• Ability to manage multiple priorities and operate effectively.

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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