This role provides strategy and technical expertise to oversee analytical activities at third party laboratories, including method validation/qualification, release testing, stability testing, and investigational testing. There is responsibility to develop, manage and monitor stability programs for commercial products, clinical trial materials, and developmental projects. There is a responsibility to provide regulatory support from early phase drug development to commercial. The candidate will also mentor and train team members, fostering their professional growth and expertise in pharmaceutical analytical testing.

• Act as the primary relationship manager for third-party vendors, overseeing all aspects of vendor management, including contract negotiation, performance evaluation, and issue resolution, to ensure optimal service delivery and value for the organization.
• Provide actionable insights and recommendations to optimize project outputs for the project teams based on holistic analysis of the analytical projects including logistics, budgeting, method development through release testing and reporting. Monitor progress, identify potential risks, implement appropriate mitigation strategies, and ensure alignment with the strategic objectives.
• Involved in the strategic selection and evaluation process for third-party vendors, conducting market research, assessing vendor capabilities, and making informed recommendations to department leadership regarding vendor partnerships that align with organizational goals and objectives.
• Lead the development and implementation of scientific strategies, ensuring alignment with regulatory requirements and industry best practices in the pharmaceutical field.
• Collaborate cross-functionally with analytical team members, regulatory affairs, quality assurance, and other departments to drive scientific excellence, resolve complex technical issues, and ensure compliance with applicable regulations and guidelines while maintaining alliance with internal timelines and corporate/project goals.
• Represent the department in external meetings, fostering inter-company relationships and staying informed about Otsuka objectives.
• Maintain and manage analytical testing documentation, including protocols, reports, and data, in compliance with good documentation practices (GDP) and data integrity standards.
• Manage pharmaceutical stability studies, including protocols and timelines, for investigational new drug (IND) and new drug application (NDA) activities, ensuring compliance with regulatory guidelines and industry standards.
• Mentor and train team members on stability study design, execution, and data analysis techniques, fostering their professional growth and expertise in pharmaceutical testing and stability studies.
• Provide subject matter expertise on testing-related topics during internal and external audits, inspections, and regulatory interactions.
• Prepare stability reports and summaries for inclusion in INDs, NDAs, and regulatory submissions, ensuring accuracy, completeness, and adherence to regulatory requirements.
• Develop and manage comprehensive budgets for various projects ensuring financial resources are effectively allocated and aligned with strategic objectives. Communicate accruals and forecast information to finance teams, providing clear and concise updates on project financial status and variances.

Qualifications

Required

• Bachelor's or master's degree in analytical science, chemistry or related science + 10 years' work experience or a Ph.D in analytical science, chemistry or related science + 5 years work experience in a GXP environment focused on analytical laboratory testing of pharmaceuticals and related materials
• Strong leadership, communication, and interpersonal skills, with the ability to influence and collaborate effectively with internal and external stakeholders
• Knowledge of the drug development lifecycle, including preclinical and clinical stages, regulatory requirements, and quality standards
• Experience with MS Office, especially MS Excel
• Experience in data review
• Must exhibit excellent oral and written communication skills

Preferred

• Ability to prioritize and manage multiple projects simultaneously, meet deadlines, and adapt to changing priorities in a dynamic environment
• Experience in LIMS user role
• Experience with investigation software (Trackwise preferred)
• Good planning and coordination skills
• Sound judgment, decision-making skills, negotiation skills, and good organizational skills
• Possess effective project management skills
• Develop and manage project budgets appropriately

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 receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

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.

Company benefits: comprehensive medical, dental, vision and prescription drug coverage, company provided Basic Life, AD&D, Short-term and Long-term Disability insurance, tuition reimbursement, a 401(k) match, PTO allotment each calendar year, paid holidays, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings;.

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