Director, Quality Analytical Technical Lead – Small Molecule

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the primary global contact and accountable owner for the analytical lifecycle management of designated commercial small-molecule products.

• Provide governance and technical direction across drug substance, drug product, and essential raw materials/reagents.

• Convert global product strategy into coordinated expectations and deliverables for internal QC sites, external QC labs/CMOs, AST, and MST.

• Lead investigations into analytical performance issues, including OOS/OOT/OOE, atypical results, and invalidations.

• Ensure thorough root cause analysis, CAPA, and method optimization is conducted.

• Drive assessments of analytical change-control impacts and execution plans, which include method updates, revalidation/verification, changes to reference standards, and instrument/software upgrades.

• Manage escalation processes for supply-critical analytical incidents and coordinate actions with Quality, Regulatory, and Supply Chain teams.

• Oversee global processes related to commercial analytical methods, specifications, stability programs, and governance of retest periods/shelf-life.

• Assume responsibility for submission-ready analytical documentation from development.

• Ensure alignment between the analytical control strategy and the product risk profile, focusing on small-molecule impurity management.

• Provide analytical Subject Matter Expert (SME) leadership for Rest of World filings and post-approval changes.

• Collaborate with Regulatory CMC on interactions with health authorities and responses.

• Govern both internal QC and external QC networks, focusing on expectations, metrics, investigation quality, and escalation pathways.

• Contribute to audits and inspections as the product analytical SME and maintain inspection readiness.

• Influence lab capacity planning and capability enhancements using a risk-based approach.

⛳️ Requirements

• A Bachelor's degree is required.

• A minimum of 10 years of biopharmaceutical experience with substantial commercial lifecycle responsibility is required.

• Proven leadership experience in GMP QC and/or analytical sciences.

• Familiarity with small-molecule methods, such as HPLC/UPLC, GC, dissolution, residual solvents, elemental impurities, and genotoxic impurities as applicable.

• Comprehensive working knowledge of method validation/verification.

• Strong understanding of stability trends and statistical evaluation.

• Extensive knowledge of specification lifecycle management.

• In-depth knowledge of data integrity principles.

• Capacity to lead through influence within a matrix organization.

• Excellent stakeholder management and negotiation skills.

• Proficient technical writing skills with the ability to create inspection-defensible narratives.

• A program and risk management mindset.

• Capability to prioritize tasks in supply-constrained environments.

• Strong proficiency in PC usage.

• Competency with MS Office applications, including Outlook, Word, Excel, and PowerPoint.

• Willingness to travel up to 20% of the time.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial roles.

• Discretionary equity awards.

• Employee Stock Purchase Plan.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) retirement plan.

• Flexible Spending Account/Health Savings Account (FSA/HSA).

• Life Insurance coverage.

• Paid Time Off (PTO).

• Access to a wellness program.

• Equal opportunity employer.

• Provision for reasonable accommodation in the job application process.