Executive Director, Structure Characterization & Elucidation

The Executive Director of Structure Characterization & Elucidation is responsible for providing strategic and technical leadership to enable deep structural understanding of drug substances and drug products and successful advancement of small molecules, biologics, and vaccines from discovery through development and commercial launch and into supply for extended characterization methods.

The Structure Characterization team provides modality agonistic characterization to solve urgent questions arising across the entire pipeline through conformational dynamics and structure elucidation, as well as delivery of structure and quantification of molecules, intermediates, and degradation products to identify potential CQAs. The team also establishes structural understanding through high resolution Mass Spectrometry and NMR characterization across modalities to build mechanistic understanding to enable insights in structure-function and molecular interactions with excipients.

The Executive Director reports to the Associate Vice President, Analytical Enabling Capabilities and will be directly responsible for a multidisciplinary team of people managers and scientists, approximately 50-60 people across our Boston, MA, Rahway, NJ, South San Francisco, CA, and West Point, PA sites. The team works closely with leaders and scientists within Discovery, Pre-clinical Development, Manufacturing, Quality Assurance and Regulatory groups and provides technical insights and support for our portfolio of projects from discovery into supply. 

The Executive Director manages the work within their group to ensure that the goals of the project teams are met in a timely, cost-sensitive, phase-appropriate and compliant manner. The Executive Director would be accountable for the growth/career development and performance of their team with a demonstrated ability to collaborate, build high-performing teams, develop diverse talent, set and achieve a strategic direction for the team, and implement and manage change to enable process improvement and optimal workflows. 

Responsibilities include, but are not limited to, the following:

• Scientific Excellence & Innovation: Responsible for leading the overall scientific, technical and operational efforts of a department within Analytical Enabling Capabilities with delivery of high-resolution Mass Spectrometry and NMR characterization data, methods, and process knowledge in a timely manner needed to meet project milestones and associated regulatory requirements. This includes development of novel methodology and processes to position Analytical Enabling Capabilities to deliver against future pipeline needs.   

• Quality and Regulatory Standards: Develops and implements phase appropriate methods for structure and quantification of molecules, intermediates, and degradation products when required. Ensures the delivery of high-quality CMC sections for IND/CTA/NDA filings. Addresses measurement and quality-related inquiries from regulatory agencies to support clinical trial and commercial marketing applications.

• Project Management and Teamwork: Responsible for managing quality and timelines for development projects and bringing analytical representation and expertise to CMC, project teams and task forces as appropriate. Facilitates teamwork and coordinates execution of plans with key stakeholders. Allocates resources and ensures tracking and follow-up as necessary.  Ensures the department works as a partner with collaborators and teams.

• Building Teams & Talent: Responsible for setting high standards, building and managing a high performing team. Sets department goals and performance objectives, supports talent development and proactively addresses performance issues. Identifies department needs and recruits/hires/promotes talent as appropriate to grow and progress the organization. Allocates proper resources for meeting goals and objectives.  

• Communications:  Maintains productive communications with staff, colleagues across Discovery and CMC development as needed to ensure understanding of needs, proper prioritization and timely delivery of product knowledge, customer-oriented data and documentation. Regularly exchanges ideas and information to develop effective plans and strategies to meet business needs. 

Education:

• MS in relevant scientific discipline with 15+ years’ experience or PhD in relevant scientific discipline with 12+ years’ experience

Required Experience and Skills:

• 12 + years of biopharmaceutical development experience.

• Subject matter expertise in structure elucidation.

• Demonstrated ability in leading large teams and mentoring and developing talent.  

• Incumbent must have excellent interpersonal, communication, and collaboration skills.

• Strength in delivering results on firm deadlines in support of drug/vaccine development.

Preferred Experience and Skills:

• Broad external network with experience advancing the field of enhanced structure elucidation capabilities.