**Associate Director, Small Molecule Analytical Development**

+ Lead and oversee phase appropriate method development and optimization for drug substance and drug product at CDMOs

+ Design and lead method validation and implementation activities for drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines

+ Develop and implement stability study protocols and timelines, including sample collection, storage conditions, and analytical testing, to support product development and regulatory submissions.

+ Author and review INDs, NDAs, and other regulatory submissions, ensuring accuracy, completeness, and adherence to regulatory requirements.

+ Perform holistic analysis of the analytical projects including logistics, budgeting, method development through release testing and reporting, providing actionable insights and recommendations to optimize project outputs for the project teams and ensure alignment with the strategic objectives. Monitor progress, identify potential risks, and implement appropriate mitigation strategies.

+ Mentor and train team members on stability study design, execution, and data analysis techniques, fostering their professional growth and expertise in pharmaceutical stability studies.

+ Collaborate cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs, quality assurance, and other departments to drive scientific excellence, resolve complex technical issues, and ensure compliance with applicable regulations and guidelines.

+ Provide CMC functional representation on wider cross-functional program development teams, ensuring all CMC considerations are accounted for in wider clinical development plans.

+ Serve as early-stage CMC representative of the department in effectively communicating program related updates, strategies, and initiatives to key stakeholders and senior management.

+ Develop and manage comprehensive budgets for various projects ensuring financial resources are effectively allocated and aligned with strategic objectives.

**Qualifications**

+ BS or MS in Analytical Sciences, Chemistry, or related field with a minimum of 12 years of experience in the biopharmaceutical industry

+ PhD in Analytical Sciences, Chemistry, or related field with a minimum of 7 years of experience in the biopharmaceutical industry

+ Direct experience in the biopharmaceutical industry working in drug substance and drug product small molecule method development, validations and implementations. Experience must include time in a GMP environment.

+ Prior experience overseeing and working with external manufacturing and analytical sites

+ Expertise in chromatographic (HPLC, UPLC, GC) and spectroscopic (MS, UV/Vis, FTIR), and other analytical techniques.

+ Strong leadership, communication (written and verbal), and interpersonal skills, with the ability to influence and collaborate effectively with internal and external stakeholders.

+ Ability to prioritize and manage multiple projects simultaneously, meet deadlines, and adapt to changing priorities in a dynamic environment

+ Deep knowledge of the drug development lifecycle, including preclinical and clinical stages, regulatory requirements, and quality standards.

**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 $164,530.00 - Maximum $245,985.00, plus incentive opportunity: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. 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, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka .

**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 Accommodation Request (EEAccommodations@otsuka-us.com) .

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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.

Job #NLX280953874