Senior Director, Head of Analytical Development

Praxis

. Set and execute analytical strategy for drug substance and drug product across small molecule and oligonucleotide portfolios .

Posted 10/9/2026full-timeRemote • United StatesSenior💰 $250,000 - $275,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in analytical method development, validation, and lifecycle management for drug substances and products, with a strong focus on regulatory compliance and cross-functional collaboration. Proven leadership in building and managing technical teams while ensuring data integrity and adherence to GMP standards.

Highest-signal resume keywords

Analytical Method DevelopmentRegulatory CMC AuthoringGMP CompliancePeople LeadershipCDMO/CRO Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Analytical ChemistryPharmaceutical SciencesMethod ValidationControl StrategiesSmall Molecule DevelopmentNucleic Acid TherapeuticsICH GuidelinesUSP/EP/JP RequirementsRegulatory FilingsData Integrity

Soft Skills

Clear CommunicationSound JudgmentOwnership Mindset

Industry Keywords

Drug SubstanceDrug ProductCMCINDIMPD/CTANDA/MAACNS DevelopmentRare Disease DevelopmentContinuous ImprovementAnalytical Technologies

About the role

Key responsibilities & impact

Set and execute analytical strategy for drug substance and drug product across small molecule and oligonucleotide portfolios
Lead analytical method development, qualification, validation, transfer, and lifecycle management
Establish specifications, comparability approaches, and control strategies with Process Development, Quality, and Regulatory Affairs
Author and review analytical CMC content for IND, IMPD/CTA, and NDA/MAA submissions
Represent Analytical Development in health authority interactions
Oversee CDMOs, CROs, and contract testing laboratories, including method transfers, stability programs, and OOS/OOT investigations
Hire, coach, and develop the analytical team
Partner with Development CMC, Process Development, Formulation Development, Clinical Supply, Quality, Regulatory Affairs, and program teams
Lead CMC teams and represent the CMC function on cross-functional program teams
Champion data integrity, GMP compliance, continuous improvement, analytical technologies, and regulatory expectations

Requirements

What you’ll need

A Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Organic Chemistry, or a related field and 15+ years of relevant pharmaceutical or biotech experience; or an M.S./B.S. with commensurately greater experience
Deep experience developing and validating analytical methods and establishing control strategies for drug substance and drug product, from early development through late-stage or commercial readiness
Direct small molecule analytical development experience
Experience with ASO, siRNA, or other nucleic acid therapeutic analytics is strongly preferred
A record of authoring and defending analytical CMC content in regulatory filings and participating in health authority interactions
Experience directing CDMO/CRO relationships and outsourced analytical testing, with the judgment to identify issues and resolve them
People leadership experience and the ability to build a technical team in a growing organization
Strong working knowledge of ICH guidelines, USP/EP/JP compendial requirements, and current GMP regulations
Clear communication and sound judgment across scientific, operational, and executive discussions
Experience in CNS or rare disease development is a plus
Ownership mindset; scientific rigor and urgency in decision-making

Benefits

Comp & perks

99% of the premium paid for medical, dental and vision plans
Company-paid life insurance
AD&D benefits
Disability benefits
Voluntary plans to personalize coverage
Dollar-for-dollar 401(k) match up to 6% on eligible contributions
Long-term stock incentives
ESPP
Discretionary quarterly bonus
Extremely flexible wellness benefit
Generous PTO
Paid holidays
Company-wide shutdowns