Associate Director, Analytical Development; Molecules

Position Summary

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. 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.

Portfolio Level Analytical Strategy & Governance Contribute 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 Provides analytical recommendations and executes agree 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 with 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.

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 of NDA analytical strategy and Health Authority engagement. Experience leading analytical functions in outsourced/CDMO‑based development models.

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…