Senior Director, Analytical Development & Quality Control

Responsibilities

• Define and execute end-to-end analytical strategies across the product lifecycle, including method development, validation, transfer, and lifecycle management from raw materials through drug substance and drug product.
• Establish phase-appropriate control strategies, specifications, and analytical approaches aligned with regulatory expectations and commercial readiness.
• Drive innovation in analytical technologies and methodologies, translating new approaches into robust, scalable platforms for development and commercial testing.
• Lead product characterization strategies, including identification and control of critical quality attributes (CQAs), impurity profiling, comparability, and stability programs.
• Act as Head of Quality Control for analytical testing supporting US and EU market authorization holders (MAHs), ensuring compliant release and support of clinical and commercial products.
• Oversee QC testing activities, including in-process, release, stability, reference standards, and impurity monitoring programs for drug substance and drug product.
• Ensure laboratories (internal and external) operate in compliance with cGMP, data integrity, and global regulatory requirements.
• Provide oversight for investigations, deviations, OOS/OOT results, complaints, and root cause analyses, ensuring timely and compliant resolution.
• Lead and manage analytical development and QC activities executed by CDMOs, CROs, and contract laboratories, ensuring quality, timelines, and cost objectives are met.
• Oversee analytical method transfer activities, including protocol design, execution, and performance monitoring across internal and external sites.
• Establish and manage budgets, resource plans, timelines, and risk mitigation strategies across programs.
• Build and maintain strong supplier relationships and oversee regulatory inspections and audit readiness of external laboratories.
• Provide strategic leadership for regulatory submission activities, including authoring, reviewing, and approving Module 3 analytical sections for INDs, IMPDs, NDAs, MAAs, and lifecycle filings.
• Lead analytical responses to health authority queries and represent the function during regulatory interactions and inspections.
• Ensure analytical development activities are aligned with ICH guidelines and global regulatory expectations.
• Partner with Drug Substance, Drug Product, Regulatory Affairs, Quality Assurance, Manufacturing, Project Management, and Research functions to advance development programs.
• Serve as analytical subject matter expert on cross-functional CMC and Product Development Teams.
• Influence strategic decision-making and drive alignment across internal stakeholders and senior leadership.

Qualifications

• PhD (preferred) or MS in Analytical Chemistry, Chemistry, Biochemistry, Chemical Engineering, or related scientific discipline.
• 12+ years (PhD) or equivalent experience in analytical development within the pharmaceutical or biotechnology industry, including significant leadership experience.
• Demonstrated experience leading analytical development and QC organizations supporting small molecule and/or peptide drug development across the lifecycle (discovery through commercialization).
• Deep expertise in analytical method development, validation, transfer, and lifecycle management.
• Strong knowledge of small molecule and/or peptide analytical techniques, including chromatography (HPLC/UPLC), mass spectrometry, impurity analysis, stability, and characterization.
• Extensive experience with control strategy development, specification setting, comparability, and regulatory-ready analytical packages.
• Proven experience overseeing stability programs, impurity tracking, and reference standard programs.
• Familiarity with quality management systems and procedures for change management, investigations, deviations, and document control.
• Strong understanding of cGMP, data integrity principles, and ICH guidelines.
• Demonstrated experience supporting global regulatory submissions (IND, IMPD, NDA, MAA) and regulatory inspections.
• Proven ability to lead cross-functional teams and influence decision-making in a matrixed organization.
• Strong external vendor management experience, including CDMOs and CRO oversight in a virtual environment.
• Track record of managing complex programs, solving technical and regulatory challenges, and delivering under aggressive timelines.
• Excellent communication and presentation skills, with the ability to convey complex technical information to diverse stakeholders.
• Strong strategic thinking, problem-solving, and risk management capabilities.
• Ability to manage multiple priorities in a fast-paced, dynamic, and highly collaborative environment.