Associate Director, Small Molecule Analytical Development

Otsuka Pharmaceutical Co., Ltd.

119d • $164,530 - $245,985

About The Position

The Associate Director, Small Molecule Analytical Development will lead and oversee phase appropriate method development and optimization for drug substance and drug product at CDMOs. This role involves designing and leading method validation and implementation activities for drug substance and drug product, ensuring compliance with relevant ICH and regulatory guidelines. The position also requires the development and implementation of stability study protocols and timelines, including sample collection, storage conditions, and analytical testing, to support product development and regulatory submissions. The Associate Director will author and review INDs, NDAs, and other regulatory submissions, ensuring accuracy, completeness, and adherence to regulatory requirements. Additionally, the role includes performing holistic analysis of analytical projects, monitoring progress, identifying potential risks, and implementing appropriate mitigation strategies. Mentoring and training team members on stability study design, execution, and data analysis techniques is also a key responsibility, along with collaborating cross-functionally with various departments to drive scientific excellence and ensure compliance with applicable regulations and guidelines.

Requirements

• 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.
• Ability to prioritize and manage multiple projects simultaneously, meet deadlines, and adapt to changing priorities.
• Deep knowledge of the drug development lifecycle, including preclinical and clinical stages, regulatory requirements, and quality standards.

Nice To Haves

• Experience in a leadership role within a biopharmaceutical company.
• Familiarity with regulatory submission processes and requirements.
• Experience in budget management and financial resource allocation.

Responsibilities

• 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.
• Author and review INDs, NDAs, and other regulatory submissions, ensuring accuracy, completeness, and adherence to regulatory requirements.
• Perform holistic analysis of analytical projects including logistics, budgeting, method development through release testing and reporting.
• Monitor progress, identify potential risks, and implement appropriate mitigation strategies.
• Mentor and train team members on stability study design, execution, and data analysis techniques.
• Collaborate cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs, quality assurance, and other departments.
• Provide CMC functional representation on wider cross-functional program development teams.
• Develop and manage comprehensive budgets for various projects.

Benefits

• Comprehensive medical, dental, vision, prescription drug coverage.
• Company provided basic life, accidental death & dismemberment insurance.
• Short-term and long-term disability insurance.
• Tuition reimbursement and student loan assistance.
• Generous 401(k) match.
• Flexible time off, paid holidays, and paid leave programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 1,001-5,000 employees