Analytical Director

Key responsibilities

• Lead the development and execution of analytical strategies
• Design and oversee the development, validation, and transfer of analytical methods in compliance with ICH, USP/EP/JP, and regulatory guidelines.
• Support regulatory filings (IND, IMPD, NDA, ANDA, BLA, etc.) by preparing analytical sections of CMC documentation.
• Represent Analytical Development in technical project teams and contribute to strategic project planning.
• Serve as a subject matter expert (SME) during regulatory agency interactions, including preparation for and participation in meetings with FDA, EMA, MHRA, and other agencies.
• Provide scientific justification for specifications, stability protocols, impurity profiles, and analytical methods.
• Interpret complex analytical data and provide risk assessments and mitigation strategies.
• Manage and guide contract testing laboratories (CROs/CMOs) in method development, transfer, and validation activities.
• Ensure all analytical activities are conducted in accordance with GMP, GLP, and regulatory compliance standards.

Job requirements:

• Experience
o Minimum 5+ years (PhD) or 8+ years (MSc) of experience in pharmaceutical analytical development.
o Proven experience in developing and implementing analytical strategies for small molecules and/or biologics.
o Solid understanding of global regulatory expectations and ability to draft and defend analytical CMC content in submissions.
o Hands-on experience with a range of analytical techniques.

• Skills

o Deep technical expertise in analytical method development and a strong understanding of regulatory expectations across development stages.
o Excellent written and verbal communication skills; ability to articulate complex scientific concepts clearly.
o Proven ability to thrive in a highly fluid, interactive, matrix environment.

• Education

o Ph.D or M.Sc. in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or closely related field.