Associate Director, Analytical and Formulation Science

The Associate Director, Analytical & Formulation Sciences provides scientific, operational, and people leadership for analytical development, characterization, testing, and support activities across biologics programs from early development through commercial manufacturing. This role leads a team of scientists and analysts responsible for analytical development, method validation, GMP testing support, stability programs, product characterization, and lifecycle management while driving operational excellence, innovation, and client success.

• Lead analytical and formulation development activities across multiple client programs.
• Manage, mentor, and develop a team of scientists and associates while fostering a culture of accountability, collaboration, and scientific excellence.
• Execute departmental objectives supporting productivity, quality, capacity, and financial targets.
• Partner with Manufacturing, Quality, Process Development, Regulatory, and Commercial teams to ensure successful program execution.
• Develop budgets, staffing plans, capital requests, and departmental performance metrics.
• Evaluate, develop, and implement innovative analytical technologies and capabilities.
• Support proposal development, technical risk assessments, and client interactions.
• Champion best practices, continuous improvement, and cross-site alignment.

• Analytical method development, qualification, transfer, and validation.
• Stability-indicating method development and lifecycle management.
• Stability program design, execution, trending, and reporting.
• GMP analytical support for clinical and commercial manufacturing operations.
• Investigation support, OOS/OOT assessments, and technical troubleshooting.
• Release testing strategy and execution for drug substance and drug product programs.
• Product characterization and comparability assessments supporting process changes and regulatory filings.
• Implementation of new technologies, automation, and operational efficiencies within analytical laboratories.

• Providing analytical support for upstream and downstream process development.
• Establishing fit-for-purpose methods for process understanding and rapid decision making.
• Supporting fermentation monitoring, product characterization, and purification development activities.

• Method development, qualification, transfer, and validation reports.
• Stability protocols, testing, trending analyses, and summary reports.
• GMP release and in-process testing support for manufacturing operations.
• Product characterization packages utilizing LC-MS, SEC, CE-SDS, IEX, icIEF, and related technologies.
• Comparability studies supporting process, site, and manufacturing changes.
• Investigation support and analytical troubleshooting for manufacturing and quality events.
• Technical data packages supporting regulatory submissions and client deliverables.
• Early-phase analytical support for process optimization and characterization studies.

BS in a scientific discipline with 15+ years of technical management experience; MS with 13+ years; or PhD with significant industry leadership experience. Minimum 5 years of people leadership experience. Strong background in analytical development, GMP testing, biologics characterization, method validation, and stability programs. Knowledge of GMP regulations and biotechnology-derived product requirements. Demonstrated success in client engagement, team development, innovation, and operational leadership.

• Quality-Focused:
  Delivers reliable, compliant, and scientifically sound results.
• Customer-Centric:
  Supports clients and manufacturing operations with urgency and accountability.
• C…