Associate Director, Analytical Development (Small Molecules)

About the role

The Associate Director, Analytical Development (Small Molecules) will lead the strategy, execution and portfolio-level of analytical development activities supporting small molecule programs from early development through NDA submission, approval, and commercialization. This role is accountable for defining and defending analytical control strategies, ensuring regulatory success, and managing analytical risk across multiple programs. The Associate Director owns analytical strategy, risk posture, and NDA analytical positioning, serves as the primary analytical interface with Regulatory Affairs and Health Authorities, and builds scalable analytical capability across the organization.

Responsibilities

• Portfolio-Level Analytical Strategy & Governance
  • Contribute to and execute analytical strategies for a portfolio of small molecule programs spanning early development through NDA and commercialization.
  • Establish consistent, risk-based approaches for:
    • Method lifecycle evolution
    • Specification setting and tightening
    • Stability strategy and shelf-life justification
  • Provide analytical recommendations and execute agreed strategies, with accountability for regulatory outcomes.
• NDA Ownership & Regulatory Leadership
  • Own the analytical narrative and positioning for NDAs, ensuring coherence across:
    • Drug substance (3.2.S)
    • Drug product (3.2.P)
    • Impurities, stability, and control strategies
  • Review, approve, and integrate analytical content authored by Senior Managers and external partners.
  • Support and participate in analytical interactions with FDA and global Health Authorities, including:
    • NDA review discussions
    • Type C and pre-NDA meetings
    • Analytical IR strategy and response alignment
  • Provide analytical SME support during pre-approval inspections (PAIs).
• Analytical Risk Management & Lifecycle Planning
  • Support risk-based assessments and provide technical input regarding:
    • Bridging vs. re-development of analytical methods
    • Timing and extent of method validation
    • Specification flexibility pre- vs. post-approval
  • Own analytical comparability and post-approval change strategies.
  • Ensure analytical approaches support long-term commercial robustness and global regulatory compliance.
• CDMO & External Partner Strategy
  • Support defining and implementing analytical governance models for CDMOs and CROs.
  • Set expectations for NDA-defensible analytical work and inspection readiness.
  • Lead escalation and resolution of high-impact analytical issues with external partners.
  • Support vendor selection, capability assessments, and long-term outsourcing strategy in partnership with Quality and Procurement.
• Cross-Functional & CMC Leadership
  • Act as a strategic thought partner to Regulatory Affairs, Quality, Process Chemistry, MSAT, and Supply Chain.
  • Influence CMC development strategy and timelines through analytical risk assessment and mitigation planning.
  • Represent Analytical Development in CMC governance forums and leadership discussions.
• People Leadership & Capability Building
  • Mentor Senior Managers and Managers; coach leaders rather than individual contributors.
  • Build and scale analytical capabilities aligned with late-stage and commercial needs.
  • Own analytical resourcing strategy, succession planning, and capability development.

Qualifications

• Education
  • Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or related discipline; or M.S. with extensive, directly relevant industry experience.
• Experience
  • 12–15+ years of pharmaceutical or biotech industry experience in small-molecule analytical development.
  • Demonstrated leadership of programs from early development through NDA filing and approval.
  • Demonstrated experience contributing to NDA analytical strategy and Health Authority engagement.
  • Experience leading analytical functions in outsourced/CDMO-based development models.
• Technical & Regulatory Expertise
  • Deep expertise in:
    • Stability indicating methods (HPLC/UPLC, GC, dissolution)
    • Impurity control (ICH Q3A/B, Q3C, genotoxic impurities)
    • Solid state characterization and stability (XRPD, DSC, TGA)
  • Strong command of ICH Q1, Q2, Q6A and FDA expectations for NDAs.
  • Demonstrated ability to develop analytically robust, inspection-ready control strategies.
• Leadership Competencies
  • Strategic thinker with strong risk-based decision-making capability.
  • Influential leader in matrixed organizations.
  • Clear, authoritative communicator with strong regulatory writing and presentation skills.
  • Proven ability to balance speed, risk, cost, and compliance.

Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage
• Company-provided basic life, accidental death & dismemberment, short-term and long-term disability insurance
• Tuition reimbursement and student loan assistance
• Generous 401(k) match
• Flexible time off, paid holidays, and paid leave programs

Pay

Minimum $169,222.00 – Maximum $253,000.00, plus incentive opportunity. The range shown represents a typical pay range for individuals hired in the role in the United States. Actual pay will be positioned within the established range based on the candidate’s experience, skills, and internal equity. Other elements may be used to determine final compensation.