Senior Director, Head of Analytical Development

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

📋 Description

• Develop and implement analytical strategies for drug substances and drug products within small molecule and oligonucleotide portfolios.

• Lead the development, qualification, validation, transfer, and lifecycle management of analytical methods.

• Collaborate with Process Development, Quality, and Regulatory Affairs to establish specifications, comparability strategies, and control measures.

• Write and review analytical CMC documentation for IND, IMPD/CTA, and NDA/MAA submissions.

• Serve as the representative of Analytical Development during interactions with health authorities.

• Manage CDMOs, CROs, and contract testing laboratories, including overseeing method transfers, stability programs, and investigations of OOS/OOT results.

• Recruit, mentor, and develop the analytical team.

• Collaborate with Development CMC, Process Development, Formulation Development, Clinical Supply, Quality, Regulatory Affairs, and program teams.

• Lead CMC teams and serve as the CMC representative in cross-functional program teams.

• Advocate for data integrity, GMP compliance, continuous improvement, analytical technologies, and adherence to regulatory expectations.

⛳️ Requirements

• A Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Organic Chemistry, or a related discipline with over 15 years of relevant experience in pharmaceuticals or biotech; or an M.S./B.S. with correspondingly more experience.

• Extensive experience in developing and validating analytical methods as well as establishing control strategies for drug substances and products, from early development stages to late-stage or commercial readiness.

• Direct experience in small molecule analytical development.

• Strong preference for experience with ASO, siRNA, or other nucleic acid therapeutic analytics.

• Proven track record of authoring and defending analytical CMC materials in regulatory submissions and engaging in health authority discussions.

• Experience managing CDMO/CRO partnerships and outsourced analytical testing, along with the ability to recognize and resolve issues effectively.

• Leadership experience with the capacity to build a technical team within a growing organization.

• Comprehensive understanding of ICH guidelines, USP/EP/JP compendial standards, and current GMP regulations.

• Excellent communication skills and sound judgment across scientific, operational, and executive discussions.

• Experience in CNS or rare disease development is advantageous.

• A proactive mindset with a commitment to scientific rigor and urgency in decision-making.

🏝️ Benefits

• 99% of the premium covered for medical, dental, and vision insurance.

• Company-sponsored life insurance.

• Accidental Death & Dismemberment (AD&D) benefits.

• Disability insurance coverage.

• Optional plans available for personalized coverage.

• Dollar-for-dollar 401(k) matching up to 6% on eligible contributions.

• Long-term stock incentives.

• Employee Stock Purchase Plan (ESPP).

• Discretionary bonuses awarded quarterly.

• Highly flexible wellness benefits.

• Generous paid time off (PTO).

• Paid holidays.

• Company-wide shutdown periods.