Associate Director, Analytical Development and Quality Control

Aligos Therapeutics•South San Francisco, CA

12h•Hybrid

About The Position

The Associate Director, Analytical Development and Quality Control will report to the Director & Head of Analytical Development and Quality Control and will be responsible for providing and executing analytical development strategy for small-molecule candidates from early development through late stage, including analytical method development, validation, and transfer; stability programs; and phase-appropriate specifications and analytical control strategies for drug substance (DS), drug product (DP), and related critical materials. The role will manage external CRO/CDMO partners in a virtual development environment and will collaborate closely with Drug Substance, Drug Product, Supply Chain, Quality, Regulatory, Nonclinical, and Clinical teams to achieve program goals.

Requirements

PhD in analytical chemistry with over 10 years, or Master's with 15 years of analytical development and Quality Control in pharmaceuticals; experienced with cGMP and drug development regulations.
Excellent scientific knowledge in analytical chemistry and experience with using traditional and advanced analytical techniques, including but not limited to HPLC, UPLC, SEC, GC, LC-MS, GC-MS, FTIR, UV, XRPD, PSD, Dissolution.
Demonstrated track record of managing CROs and CDMOs, preferably on both analytical and bioanalytical projects, in developing methods and quality control strategy for testing of small-molecule drug candidates supporting Phase I to commercial launch.
Demonstrated track record in preparing analytical sections of IND/IMPD and NDA/MAA.
Experience in preparing, reviewing and submitting required documentation pertaining to the cGMP and GLP environment.
Excellent verbal and written communication skills.
Excellent data presentation & analysis skills, including creation of publication quality tables & graphs.
Fastidiously detail-oriented and organized. Impeccable attention to data QC.
Ability and proven track record of successfully working in cross-functional teams to progress projects as a representative Analytical function.
Ability to navigate and be successful in a fast-paced biotech work environment. Distinguishes research from development.
A desire to be part of a highly innovative company aimed at helping patients with serious diseases.
All candidates are expected to have authorization to work in the United States.

Responsibilities

Develops and executes phase-appropriate analytical strategies and plans to support development of small-molecule candidates (preclinical through Phase 3 and registration readiness), aligned with project goals, budgets, and timelines.
Leads external CRO/CDMO activities for analytical method development, optimization, validation, verification, and transfer for assay, purity/impurities, and discriminating dissolution methodologies; supports identification/qualification of impurities and degradation products; reference standard qualification; and physical (solid-state) characterization as needed.
Develops and maintains phase-appropriate analytical control strategies for DS and DP, applying risk-based principles and Quality by Design (QbD) concepts where appropriate.
Designs, manages, and monitors DS and DP stability programs, ensuring protocols, pulls, testing, and reporting support clinical supply needs and regulatory objectives (including retest and expiration dating, and their extension through appropriate extrapolation).
Reviews and quality-checks analytical data packages (e.g., batch release, stability, validation/verification packages), ensuring scientific soundness, traceability, and appropriate conclusions.
Partners with CRO/CDMOs and internal stakeholders to troubleshoot analytical issues and lead/support investigations (e.g., OOS/OOT, deviations), including definition of root cause, CAPA recommendations, and change control support as applicable.
Authors, reviews, and approves technical documentation including analytical methods, development reports, validation protocols and reports, stability protocols and reports, specifications, and data summaries.
Serves as the Analytical Development and Quality Control representative on cross-functional project teams and communicates status, risks, mitigation plans, and key decisions at program and functional meetings.
Contributes to regulatory submissions by authoring/reviewing analytical sections of CMC dossiers (e.g., IND/IMPD, NDA/MAA) and supporting responses to health authority questions.
Supports selection and oversight of external vendors, including technical evaluations, scope definition, RFP inputs, and participation in vendor audits as needed.
Manages budgets for analytical development activities and supports contracting workflows (e.g., SOW review, work order approvals) in coordination with internal partners.
Participates in initiatives to improve functional processes and technical operations within CMC, including development/revision of SOPs in collaboration with Quality.