Director, Analytical Development

Role Summary

Director, Analytical Development. Based in Watertown, MA and reporting to the Sr. Director of Analytical Development, this position is responsible for the implementation of evolving scientific technologies to advance the development of ocular drug products towards commercialization.

Responsibilities

• Evaluate and implement new analytical technologies and contribute to strategic planning for analytical development and control strategies for small molecules.
• Collaborate in development and phase appropriate qualification or validation of analytical methods for release, stability, comparability and in-process testing.
• Cooperatively work with CMC teams and personnel from other departments such as Formulation Development, Quality Control and Quality Assurance, Regulatory Affairs, and Project Management.
• Ensure that all work is conducted in accordance with applicable policies and procedures, cGMP and regulatory standards and guidelines. Maintain an understanding of current laws & regulations applicable to the pharmaceutical/biotechnology industry.
• Guide method transfer and troubleshooting at contract testing labs and CDMOs.
• Perform data review, statistical analysis and method optimization for complex physicochemical methods.
• Lead characterization studies for structural elucidation and fate and purge studies to support regulatory submissions. Lead technical assessments and risk analyses to inform program strategies.
• Develop phase appropriate control and release strategies, specifications to support GMP manufacturing of drug substance and drug product.
• Identify, plan and complete necessary product and container compatibility, leachables and extractables studies necessary for the stage of the regulatory submission.

Qualifications

• Proven expertise in design, development, qualification, validation, and lifecycle management of analytical methods for drug substances and drug products for small molecules.
• Solid knowledge of late-stage analytical development for drug substance and drug product development (Phase 3 to commercialization).
• Proficiency with analytical instrumentation such as HPLC, UPLC, LC-MS, GC, GPC and advanced technical skills in solid state characterization of drug substance/intermediates/final product functionality (e.g. Rheology, XRPD, TGA, DSC, DVS, BET, IR, Raman, microscopy, particle size analysis, etc).
• Experience with large molecule characterization techniques is a plus.
• In-depth knowledge of current regulatory guidance including ICH, FDA, EMA/JP and experience in managing IND/IMPD and NDA filings.
• Experience in managing external contractors and contract development and manufacturing organizations (CROs, CDMOs) for analytical activities, including method development and validation.
• Excellent time management, project management, and strategic thinking.
• Flexible, adaptable and collaborative style with a willingness to take on new challenges and positively respond to changes.
• Excellent interpersonal, technical writing, and oral communication skills.
• Able to identify key performance metrics, generate actionable reports and communicate complex information clearly to internal stakeholders.
• A team player who is able to collaborate effectively with a broad range of internal functions.
• Possesses high integrity and exceptional work ethic.
• Ability to travel domestically to achieve goals, when required.
• Supervisory experience is a plus.

Education

• PhD in Analytical Chemistry or related scientific field with 15+ years industry experience.

Experience

• At least 12 years of relevant experience in the pharmaceutical industry