Associate Director, Molecule Analytical Development

## Associate Director, Small Molecule Analytical Development Apply:
On Campus:
Cambridge, MA:
Full time:
Posted Today:
REQ
24349
** About This Role
** The Associate Director, Small Molecule Analytical Development will provide scientific and people leadership for analytical development activities supporting small molecule programs from early clinical development through late-stage registration and commercialization. This role is responsible for developing phase-appropriate analytical strategies, overseeing method development and validation, supporting impurity control and specification setting, and contributing to CMC regulatory submissions. The position works closely with cross-functional partners and external organizations to support reliable clinical supply, regulatory readiness, and commercialization objectives.
** Who We Are
** The Small Molecule Analytical Development team develops analytical methods, control strategies, and supporting data packages for small molecule therapeutics. The team partners with process chemistry, chemical engineering, solid form, formulation, quality, regulatory CMC, manufacturing, clinical supply, and external development partners to support development programs and regulatory submissions. The team emphasizes scientific rigor, collaboration, data-driven decision-making, operational excellence, and continuous improvement.
** What You’ll Do
*** Lead analytical development activities for small molecule drug substance and drug product programs, including method development, qualification, validation, transfer, lifecycle management, and routine control strategy support.
* Develop and implement phase-appropriate analytical control strategies for identity, assay, impurities, degradation products, residual solvents, elemental impurities, solid-state attributes, dissolution, and other critical quality attributes.
* Provide technical guidance for impurity identification and characterization, forced degradation, stability strategy, comparability assessments, and specification justification.
* Represent Analytical Development on cross-functional CMC project teams and contribute to project strategy, risk assessment, planning, and decision-making.
* Author and review analytical content for regulatory submissions and technical documents, including INDs, CTAs, NDAs/MAAs, briefing packages, responses to health authority questions, validation reports, transfer reports, and internal technical reports.
* Collaborate with Process Chemistry, Chemical Engineering, Solid Form, Formulation, Quality, Regulatory CMC, Manufacturing, and Clinical Supply to align analytical methods and specifications with process understanding, product performance, and program needs.
* Oversee analytical activities conducted by contract research, development, and manufacturing organizations, including review of protocols, reports, results, timelines, and quality expectations.
* Manage, mentor, and develop scientists, supporting performance, career development, inclusive teamwork, and a culture of accountability and continuous improvement.
* Evaluate and implement analytical technologies, digital tools, automation, and data approaches that improve productivity, method robustness, compliance, and decision-making.
* Represent the function internally and, as appropriate, externally through scientific presentations, publications, professional organizations, consortia, or industry forums.
** Who You Are
** The successful candidate will have experience leading analytical development activities in a pharmaceutical or biotechnology setting and will be able to apply technical expertise, sound judgment, and collaborative leadership to support development programs. The candidate should be able to communicate clearly with…