Associate Director of Analytical Development
Boston, MA
Currently partnered with a leading Biopharmaceutical company dedicated to developing innovative biologic therapies to improve patient outcomes. They are seeking a highly skilled and motivated Associate Director of Analytical Development to join their dynamic team.
The Associate Director of Analytical Development will lead be responsible for the development, validation, and implementation of analytical methods for biologic drug substances and products. This role will oversee all aspects of analytical activities, including method development, transfer, qualification, and stability testing, ensuring compliance with regulatory requirements and industry standards
Key Responsibilities:
- Lead and manage the analytical efforts across the development and testing of biologic drug substances and products.
- Oversee method development, transfer, qualification, and troubleshooting activities for the characterization and release testing of biologics.
- Collaborate with cross-functional teams, including process development, quality, clinical, and regulatory, to ensure alignment and successful project execution.
- Establish and implement phase-appropriate quality control strategies and set specifications for biologic products.
- Manage stability programs and oversee stability studies at Contract Development and Manufacturing Organizations (CDMOs).
- Author and review technical reports, protocols, and regulatory submissions, including IND, IMPD, BLA, and MAA filings.
- Ensure compliance with cGMP, ICH guidelines, and other regulatory requirements.
- Build and maintain strong relationships with internal and external partners to support analytical development activities.
- Provide leadership in the development of scientific capabilities and analytical strategies within the team.
Qualifications:
- Ph.D. in Analytical Development, Chemical Engineering, or a related discipline with a minimum of 6 years of relevant industry experience, or M.S. with 8 years, or B.S. with 10 years of experience.
- Extensive experience in analytical development for biologics, including monoclonal antibodies, ADCs, or multidomain protein biologics.
- Strong knowledge of regulatory requirements and guidelines related to biologic drug development.
- Proven track record of leading method development, qualification, and validation activities.
- Excellent leadership, communication, and project management skills.
- Ability to work collaboratively in a cross-functional team environment.
- Experience with CDMOs and managing external partnerships is highly desirable.
Benefits:
- Competitive salary and benefits package.
- Opportunity to work in a dynamic and innovative environment.
- Professional development and career growth opportunities.
