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Associate Director

3 months ago

Boston, United States AL Solutions Full time
Job DescriptionJob Description

One of AL Solutions leading biotech client's is looking for an Associate Director of Analytical Development CMC. In this role you will play a critical role in ensuring the quality and compliance of pharmaceutical products through the development and implementation of analytical strategies. You will provide expert scientific and technical support to internal teams and external partners in the areas of method development, validation, transfer, and troubleshooting.

Your responsibilities will include:

  • Leading the design, development, and implementation of analytical methods for product characterization, release testing, and stability studies
  • Overseeing method validation activities and ensuring compliance with regulatory standards and guidelines
  • Collaborating with internal and external stakeholders to transfer methods between laboratories
  • Performing data analysis and interpretation to support product development and regulatory submissions
  • Identifying and resolving technical issues related to analytical methods and instrumentation
  • Providing technical guidance and mentoring to junior staff members
  • Keeping up-to-date with advancements in analytical techniques and regulatory requirements

Requirements

To be successful in this role, you should have:

  • A Ph.D. or Master's degree in Chemistry, Pharmaceutical Sciences, or a related field
  • A minimum of 8 years of experience in analytical development in the pharmaceutical industry
  • Proven expertise in method development, validation, transfer, and troubleshooting
  • Strong understanding of regulatory requirements and guidelines (e.g., ICH, FDA, EMA)
  • Excellent communication and collaboration skills
  • Ability to work effectively in cross-functional teams and multi-site organizations
  • Strong problem-solving and decision-making abilities
  • Experience in leading and mentoring junior scientists