Associate Director, Analytical (Structural Characterization)

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.

Key Responsibilities

Scientific & Technical Leadership

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.

Analytical Techniques & Platforms

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.

CMC & Regulatory Support

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.

Cross-Functional Collaboration

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.

People & Project Leadership

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.

Qualifications

Education

PhD in Analytical Chemistry, Organic Chemistry, Pharmaceutical Sciences, or a related discipline

or

MS with significant and progressive industry experience

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

Skills & Competencies

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

Competencies

Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.

Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.

Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.

Impactful Communication -  Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.

Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.

Empowered Development - Play an active role in professional development as a business imperative.

Minimum $169,222.00 - Maximum $253,000.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Application Deadline : This will be posted for a minimum of 5 business days.

Company 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, and paid leave programs as well as other company provided benefits.

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Disclaimer: 

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer.  All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability.  You can request reasonable accommodations by contacting EEAccommodations@otsuka-us.com .

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