Associate Director, Analytical (Structural Characterization)

Otsuka Pharmaceutical Co., Ltd; United States; Hybrid; USD 169,000 - 253,000; Full time

Benefits offered by this job

Comprehensive medical, dental, vision,

401(k) match

Flexible time off

Paid holidays

Tuition reimbursement

Student loan assistance

Job summary

Otsuka America Pharmaceutical Inc. seeks an Associate Director, Analytical – Structural Characterization to lead strategy and execution of small molecule structural characterization across development stages.

You will drive analytical methods, interpret data for CMC decisions, and collaborate with process chemistry, formulation, manufacturing, quality, and regulatory teams in a fast‑paced environment.

Qualifications

• PhD in Analytical Chemistry, Organic Chemistry, Pharmaceutical Sciences, or related field, or MS with significant industry experience.
• 8–10+ years of small molecule analytical development experience in pharma/biotech.
• Demonstrated expertise in structural elucidation, impurity characterization, and solid‑state chemistry.
• Experience supporting CMC development and regulatory submissions (IND/NDA).
• Prior people leadership or matrix leadership experience preferred.

Responsibilities

• Scientific & Technical Leadership: provide SME for small molecule structural characterization and impurities.
• Define and execute analytical strategies to support process development, scale‑up, comparability, lifecycle management.
• Lead investigations of complex analytical/CMC issues related to structure, impurities, and stability.
• Interpret and integrate analytical data to guide critical CMC and development decisions.
• Partner with Process Chemistry, Formulation, Manufacturing, Quality, and Regulatory Affairs.

Skills

Scientific & Technical Leadership

Cross‑Functional Collaboration

People & Project Leadership

Strategic Thinking & Problem Solving

Impactful Communication

Education

PhD in Analytical Chemistry or related field

Tools

NMR

MS (LC-MS, HRMS)

IR/Raman/UV

HPLC/UPLC

GC

XRPD

DSC

TGA

Job description

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

• 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.
• 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.

Compensation

• 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.

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.
• Paid leave programs as well as other company provided benefits.

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.

Equal Opportunity Statement

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 [e-mail].

Company Information

Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre‑existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” In the U.S., Otsuka is comprised of two companies, Otsuka America Pharmaceutical, Inc., and Otsuka Pharmaceutical Development & Commercialization, Inc., that share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and digital medicine. Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day. OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023. We invite you to explore our open positions for an opportunity to join our 2,200 colleagues in the U.S. whose passion for our mission and pride in our company have earned us certification as a Great Place to Work by the Great Place to Work Institute.