Associate Director - Analytical Cmc

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