jazzhr
Senior Director, Analytical Development & Quality Control
Rhythm Pharmaceuticals
Boston, USA
Full-time
Senior Level
Hybrid
USD 210000-370000 yearly
Discovered 1 weeks ago
Free
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- 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.
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