Senior Director, Analytical Sciences

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

📋 Description

• Provide strategic and technical oversight for analytical operations that support the development, registration, validation, launch, and lifecycle management of the company's small molecule drug substance and product portfolio.

• Establish and guide analytical strategies across the portfolio utilizing risk-based, phase-appropriate, and fit-for-purpose methodologies.

• Act as the company's subject matter expert in analytical chemistry and pharmaceutical analysis.

• Create and implement comprehensive analytical strategies for drug substances, drug products, raw materials, impurities, and reference standards.

• Take ownership of method development, qualification, validation, transfer, verification, and lifecycle management.

• Set specifications, impurity control measures, characterization methods, reference standards, and stability programs.

• Lead investigations of out-of-specification (OOS) and out-of-trend (OOT) results, deviations, corrective and preventive actions (CAPAs), and complex analytical troubleshooting.

• Oversee the selection, governance, and evaluation of external analytical partners, including contract development and manufacturing organizations (CDMOs), contract research organizations (CROs), and contract testing laboratories.

• Write, review, and approve analytical documentation for global regulatory submissions and assist with inquiries from health authorities, audits, and inspections.

• Ensure external partners adhere to current Good Manufacturing Practices (cGMP), quality agreements, and company standards.

• Facilitate analytical preparedness for process validation, product launch, continuous process verification, and post-approval changes.

• Collaborate with Drug Substance, Drug Product, Quality, Regulatory, Supply Chain, and Program Management teams on integrated Chemistry, Manufacturing, and Controls (CMC) plans.

• Manage budgets, timelines, resources, and technical risks across various programs; develop and mentor the team as the organization expands.

⛳️ Requirements

• Ph.D. in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or a related scientific discipline; an M.S. with significant directly relevant experience may be considered.

• Generally, 15 or more years of relevant experience in the pharmaceutical or biotechnology industry, including progressively responsible leadership in analytical development or analytical sciences.

• Proven experience supporting small molecule products from development through regulatory submission, approval, launch, and throughout the commercial lifecycle.

• Extensive knowledge in analytical method development, validation, transfer, stability, specifications, and impurity control for both drug substances and drug products.

• Strong understanding of cGMP requirements, ICH guidelines, compendial standards, data integrity principles, and global CMC regulatory requirements.

• Demonstrated ability to lead external analytical partners while managing budgets, timelines, and technical risks across multiple initiatives.

• Exceptional written, verbal, and executive-level communication skills.

• Willingness to travel up to 10%, including frequent overnight trips outside the local area.

• Preferred: experience in a virtual, externally networked, or significantly outsourced pharmaceutical operating model.

• Preferred: experience with oral solid dosage forms, late-stage development, process validation, and readiness for commercial launch.

• Preferred: experience in establishing an Analytical Sciences function and implementing scalable governance and operational processes.

🏝️ Benefits

• Medical insurance

• Dental insurance

• Vision insurance

• Paid time off

• 401K

• Participation in Mineralys incentive plans contingent on the achievement of personal and company performance