Associate Director/Director, Analytical Development

Role Summary

We are looking for an experienced Analytical Associate Director/Director to join our expanding CMC team. This position works directly with the Senior Director of Analytical Development, CMC and manages an analytical team that oversees multiple CDMOs analytical development and quality control activities. If you have a complete understanding of GMP requirements and experience working on various drug development phases, we would love to hear from you!

Responsibilities

• Oversee both international and US based contract development and manufacturing organizations (CDMOs) to manage analytical development and quality control (QC) activities for our drug substance (DS) and drug product (DP) suppliers
• Lead, coach and develop a team of direct reports, fostering a high-performance growth-oriented culture
• Manage DS and DP stability programs and corresponding shelf-life determinations
• Regularly and clearly communicate Analytical Development and QC topics both verbally and in visual presentation form, efficiently and contextually
• Support and author analytical content for CMC Regulatory for US and Rest of World dossiers
• Support Quality Assurance audits, as a QC subject matter expert, as needed
• Provide on-site technical support on an as-needed basis to oversee various manufacturing/scale-up/validation activities
• Proactively interface effectively with other CMC team members (e.g. Process Chemistry, Formulation Development, Quality Assurance, Supply Chain, etc.)

Qualifications

• Degree (BS or MS) with 7+ years of relevant analytical chemistry experience. PhD preferred
• Oversite of external QC laboratories (e.g., method development, method validation & troubleshooting analytical procedures)
• Experience with stability and shelf-life management
• Practical working knowledge of ICH guidance
• Knowledge of small molecule chemical characterization techniques
• Broad understanding of analytical techniques, with a focus on (U)HPLC
• Hands-on GMP experience with all phases of drug development including authoring IND/IMPD and marketing applications, as well as in-depth knowledge and complete understanding of GMP requirements
• Ability to critically evaluate and troubleshoot complex problems while offering timely and informed options for resolution
• Strong verbal & written communication skills, with the ability to effectively interact with and influence different functional groups across all levels of management
• Position requires up to 20% travel
• Strong focus on quality and attention to detail

Education

• Degree (BS or MS) with 7+ years of relevant analytical chemistry experience. PhD preferred

Additional Requirements

• Position requires up to 20% travel