Position Summary
The Analytical Method Sciences team partners across the global quality analytical science and technology organization to deliver quality separations methods and specifications to be used for commercial release and stability testing of our biopharmaceutical products. Reporting to the Director of Analytical Method Sciences (AMS) in Analytical Science and Technology (AS&T) the Associate Director of Separations provides strategic and organizational leadership for the AMS Separations organization while maintaining deep expertise in analytical methodologies used to support commercial biologics testing and lifecycle management. The role is responsible for building organizational capability, developing scientific talent, establishing strategic priorities, and ensuring successful execution of analytical lifecycle activities supporting commercial product supply. The Associate Director leads a team of scientists supporting chromatographic, electrophoretic, and characterization methods including SEC, CEX, CE-SDS, icIEF, peptide mapping, glycan analysis, SDS-PAGE, UV/Vis, and related analytical technologies. Leveraging strong technical expertise, the incumbent provides direction on complex scientific issues, influences analytical strategy, and ensures the organization maintains the capabilities required to support current and future business needs. Responsibilities also include contributing to the analytical CMC strategy and dossier authorship for licensure, including contributing technical expertise to assist in responding to Health Authority queries. As a member of the AMS leadership team, the Associate Director drives organizational effectiveness, operational excellence, talent development, and strategic execution while fostering a culture of accountability, innovation, inclusion, and continuous improvement.
Location
Cruiserath, Devens
Key Responsibilities
Strategic Leadership & Organizational Development
- Define and execute the strategic vision for the AMS Separations organization in alignment with business and functional objectives.
- Build organizational capability through talent development, succession planning, workforce planning, performance management, and strategic hiring.
- Develop future technical and people leaders, creating a sustainable pipeline of scientific talent.
- Establish priorities and allocate resources across multiple products, platforms, and business initiatives.
- Drive organizational effectiveness, flexibility, simplification, and continuous improvement initiatives.
- Foster a culture of accountability, collaboration, technical excellence, and innovation.
Technical Leadership & Scientific Excellence
- Maintain deep expertise in development and commercial analytical GMPs, in analytical separation methodologies including SEC, CEX, CE-SDS, icIEF, peptide mapping, glycan analysis, and related technologies used to characterize biologics.
- Provide strategic oversight and scientific direction for analytical lifecycle management, validation, transfer, comparability, remediation, and method performance monitoring activities.
- Serve as the technical escalation point for complex scientific issues, analytical risks, and business-critical decisions.
- Ensure appropriate scientific rigor, risk assessment, and governance across analytical programs.
- Guide the organization's technical strategy and ensure the development of capabilities required to support evolving portfolio needs.
- Coach and develop scientists in technical decision-making, problem-solving, and scientific leadership.
Cross-Functional and Business Leadership
- Partner with Quality Control, Analytical Development, MS&T, Regulatory, Manufacturing, and Product Teams to develop and execute analytical strategies.
- Drive alignment between commercial needs, analytical capabilities, and resource planning.
- Support regulatory submissions, inspections, audits, and health authority interactions as a technical and strategic leader.
- Influence organizational and business decisions through strong technical and leadership credibility.
Qualifications & Experience
Preferred Experience
- Significant experience in analytical sciences supporting biologics development, commercialization, licensure, and lifecycle management.
- Demonstrated expertise in analytical characterization methodologies including SEC, CEX, CE-SDS, icIEF, peptide mapping, glycan analysis, and other techniques used to support biologics control strategies.
- Experience developing, validating, transferring, and sustaining analytical methods while establishing lifecycle management and validation strategies aligned with industry’s best practices and global regulatory expectations.
- Strong understanding of Quality Control operations, analytical testing, cGMP/GDP requirements, quality systems, and product quality investigations within regulated environments.
- Experience authoring, reviewing, and supporting regulatory submissions, health authority interactions, and inspection readiness activities.
- Proven success leading scientific organizations responsible for analytical lifecycle management, investigations, technical problem-solving, and commercialization support.
- Demonstrated ability to build high-performing teams, develop scientific talent, and create organizational capability through coaching, succession planning, and strategic leadership.
- Strategic thinker with strong business acumen and a proven ability to translate organizational strategy into operational execution while balancing scientific excellence, compliance, and business priorities.
- Strong leadership, communication, influencing, and stakeholder management skills with demonstrated success working across complex global matrix organizations.
- Proven ability to lead through change, drive innovation and continuous improvement, and deliver sustainable business results in a rapidly evolving environment.
Education / Experience
- PhD in Chemistry, Biochemistry, Biological Sciences, Pharmaceutical Sciences, or related scientific discipline with 10+ years of relevant industry experience; or MS or BS degree with 15+ years of relevant industry experience. Experience in a commercial QC is a plus.
- Significant experience supporting and leading analytical sciences, biologics characterization, quality, and commercialization activities within the biopharmaceutical industry.
- Demonstrated people leadership experience leading scientific and technical organizations in regulated environments.