Associate Director, Small Molecule Analytical Development

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 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.

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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