Manager, CMC Analytical Development

Location
New York City, New York
Salary
Compensation commensurate with experience
Posted
Oct 12, 2018
Closes
Nov 11, 2018
Field of specialization
Analytical
Work Function
Management-General
Job Type
Full time

ESSENTIAL ROLE AND RESPONSIBILITIES

  1. Provide technical oversight of outsourced analytical activities to enable timely delivery of supplies for portfolio programs.
  2. Analyze results, solve analytical issues, and meet regulatory expectations for analytics applied to small molecule drug substances and drug products.
  3. Author, review and approve analytical related change controls, deviations, CAPAs, and risk assessments.
  4. 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.
  5. Provide on-site presence at CDMOs for audit, training, meetings as needed to achieve objectives.
  6. Manage tracking of analytical reference standards and impurities.
  7. Review stability studies for drug substances and drug products to support retest date or shelf-life.
  8.   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.
  9. Flexibility to travel up to 25% domestic/international

ESSENTIAL KNOWLEDGE, SKILLS AND EXPERIENCE

  1. Ph.D. or M.S. in Chemistry with 10+ years of related pharmaceutical development experience.
  2. In-depth working knowledge of analytical techniques, analytical method development, method transfer, method validation and stability.
  3. Knowledge in biologic analytical methods is a plus.
  4. Ability to understand complex processes, identify knowledge gaps and propose efficient and effective solutions to issues.
  5. Experience in regulatory filings, specifications and controls, analytical method development and validation and the commercialization process.
  6. Knowledgeable of ICH guidelines and FDA Guidance related to Pharmaceutical development, validation, manufacturing and stability of drug substance and drug product.
  7. Experience in actively managing outsourcing to contract development and manufacturing organizations.
  8. Ability to work independently in a cross-functional team environment.
  9. Ability to manage multiple priorities and operate effectively.
  10. Excellent written and oral communication skills.

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