Associate Director, Analytical (Structural Characterization)

Otsuka Pharmaceutical Co., Ltd. • Princeton, NJ

5d • $169,222 - $253,000

About The Position

The Associate Director, Analytical – Structural Characterization will lead the scientific strategy and execution of small molecule structural characterization across all phases of development, from early discovery support through commercial lifecycle management. This role is responsible for ensuring comprehensive understanding and control of molecular structure, impurities, solid-state form, and degradation behavior to support process development, formulation, regulatory submissions, and commercialization. The position requires strong technical expertise, cross-functional leadership, and the ability to operate effectively in a fast-paced small company environment.

Requirements

• PhD in Analytical Chemistry, Organic Chemistry, Pharmaceutical Sciences, or a related discipline or MS with significant and progressive industry experience
• 8–10+ years of experience in small molecule analytical development in the pharmaceutical or biotech industry
• Demonstrated expertise in structural elucidation, impurity characterization, and solid-state chemistry
• Experience supporting CMC development and regulatory submissions (IND/NDA)
• Prior people leadership or strong matrix leadership experience preferred
• Deep understanding of small molecule chemistry and analytical control strategies
• Strong problem-solving, troubleshooting, and data interpretation capabilities
• Ability to communicate complex analytical concepts to cross-functional and executive stakeholders
• Experience working in GxP-regulated environments
• Comfortable operating in a resource-conscious, fast-moving small company setting

Responsibilities

• Provide subject matter expertise for small molecule structural characterization, including molecular identity, impurity profiling, degradation pathways, and solid-state properties.
• Define and execute analytical strategies to support process development, scale-up, comparability, and lifecycle management.
• Lead investigation and resolution of complex analytical and CMC issues related to structure, impurities, and stability.
• Interpret and integrate analytical data to guide critical CMC and development decisions.
• Oversee development, qualification, and validation of methods including (but not limited to): Spectroscopic techniques: NMR (1D/2D), MS (LC-MS, HRMS), IR, Raman, UV; Chromatographic methods: HPLC/UPLC (reverse phase, normal phase, chiral), GC; Impurity and degradation analysis: forced degradation, extractables/leachables, genotoxic impurities; Solid-state characterization: XRPD, DSC, TGA, DVS, microscopy, polymorph and salt screening.
• Drive adoption of fit-for-purpose methods aligned with development stage and regulatory expectations.
• Support CMC strategies for IND, NDA, and post-approval submissions, including impurity justification and solid-form control.
• Author, review, and approve analytical sections of regulatory documents and responses to health authority questions.
• Ensure analytical approaches are compliant with ICH, FDA, and global regulatory guidance for small molecules.
• Contribute to setting specifications, control strategies, and stability programs.
• Partner closely with Process Chemistry, Formulation, Manufacturing, Quality, and Regulatory Affairs teams.
• Support selection and control of API solid form and formulation-relevant attributes.
• Manage and oversee work performed by external CROs, CDMOs, and analytical vendors.
• Provide project leadership, ensuring analytical deliverables are met on time and with high quality.
• Contribute to departmental planning, budgeting, and continuous improvement initiatives.
• Establish scalable analytical processes appropriate for a growing organization.

Benefits

• Comprehensive medical, dental, vision, prescription drug coverage
• Company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance
• Tuition reimbursement
• Student loan assistance
• A generous 401(k) match
• Flexible time off
• Paid holidays
• Paid leave programs

What This Job Offers

• Job Type: Full-time
• Career Level: Senior