Otsuka America Pharmaceutical Inc.
Associate Director, Small Molecule Analytical Development
Otsuka America Pharmaceutical Inc., Concord, New Hampshire, United States, 03306
Associate Director, Small Molecule Analytical Development
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, to support product development and regulatory submissions. Author and review regulatory submissions (INDs, NDAs, and other 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, providing actionable insights and recommendations to optimize project outputs and align with strategic objectives. Monitor progress, identify potential risks, and implement mitigation strategies. Mentor and train team members on stability study design, execution, and data analysis techniques to foster professional growth in pharmaceutical stability studies. Collaborate cross-functionally with analytical teams, process chemistry, formulation development, regulatory affairs, quality assurance, and other departments to drive scientific excellence, resolve complex technical issues, and ensure regulatory compliance. Provide CMC functional representation on wider cross-functional program development teams, ensuring CMC considerations are accounted for in clinical development plans. Serve as early-stage CMC representative to communicate program updates, strategies, and initiatives to key stakeholders and senior management. Develop and manage comprehensive budgets for projects, ensuring resources are allocated aligned with strategic objectives. Qualifications
BS or MS in Analytical Sciences, Chemistry, or related field with a minimum of 12 years of biopharmaceutical industry experience. PhD in Analytical Sciences, Chemistry, or related field with a minimum of 7 years of biopharmaceutical industry experience. Direct experience in small molecule drug substance and drug product method development, validation, and implementation in a GMP environment. Experience overseeing and working with external manufacturing and analytical sites. Expertise in chromatographic (HPLC, UPLC, GC) and spectroscopic (MS, UV/Vis, FTIR) analytical techniques, and other analytical methods. Strong leadership, communication (written and verbal), and interpersonal skills with the ability to influence and collaborate with internal and external stakeholders. Ability to prioritize and manage multiple projects concurrently, 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 strategic objectives, uphold high performance standards, and lead change. Strategic Thinking & Problem Solving - Make decisions considering long-term impact to customers, patients, employees, and the business. Patient & Customer Centricity - Maintain focus on the needs of customers and key stakeholders. Impactful Communication - Communicate with logic, clarity, and respect; influence across levels to achieve results. Respectful Collaboration - Value diverse perspectives and partnerships to achieve common goals. Empowered Development - Actively pursue professional development as a business imperative. Compensation & Benefits
Minimum $164,530.00 – Maximum $245,985.00, plus incentive opportunity. The range represents typical pay for roles in the United States and may be adjusted based on experience, skills, and internal considerations. Other compensation elements may apply according to local laws. Application Deadline
This position will be posted for a minimum of 5 business days. Company Benefits
Comprehensive medical, dental, vision, prescription drug coverage; company-provided life insurance, AD&D, short- and long-term disability; tuition reimbursement; student loan assistance; generous 401(k) match; flexible time off; paid holidays and paid leave programs, among other benefits. Equal Opportunity & Accommodation
Otsuka is an equal opportunity employer. All qualified applicants will be considered without regard to race, color, sex, gender identity or expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or other legally protected characteristics. If you require a reasonable accommodation, please contact Accommodation Request (EEAccommodations@otsuka-us.com).
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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, to support product development and regulatory submissions. Author and review regulatory submissions (INDs, NDAs, and other 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, providing actionable insights and recommendations to optimize project outputs and align with strategic objectives. Monitor progress, identify potential risks, and implement mitigation strategies. Mentor and train team members on stability study design, execution, and data analysis techniques to foster professional growth in pharmaceutical stability studies. Collaborate cross-functionally with analytical teams, process chemistry, formulation development, regulatory affairs, quality assurance, and other departments to drive scientific excellence, resolve complex technical issues, and ensure regulatory compliance. Provide CMC functional representation on wider cross-functional program development teams, ensuring CMC considerations are accounted for in clinical development plans. Serve as early-stage CMC representative to communicate program updates, strategies, and initiatives to key stakeholders and senior management. Develop and manage comprehensive budgets for projects, ensuring resources are allocated aligned with strategic objectives. Qualifications
BS or MS in Analytical Sciences, Chemistry, or related field with a minimum of 12 years of biopharmaceutical industry experience. PhD in Analytical Sciences, Chemistry, or related field with a minimum of 7 years of biopharmaceutical industry experience. Direct experience in small molecule drug substance and drug product method development, validation, and implementation in a GMP environment. Experience overseeing and working with external manufacturing and analytical sites. Expertise in chromatographic (HPLC, UPLC, GC) and spectroscopic (MS, UV/Vis, FTIR) analytical techniques, and other analytical methods. Strong leadership, communication (written and verbal), and interpersonal skills with the ability to influence and collaborate with internal and external stakeholders. Ability to prioritize and manage multiple projects concurrently, 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 strategic objectives, uphold high performance standards, and lead change. Strategic Thinking & Problem Solving - Make decisions considering long-term impact to customers, patients, employees, and the business. Patient & Customer Centricity - Maintain focus on the needs of customers and key stakeholders. Impactful Communication - Communicate with logic, clarity, and respect; influence across levels to achieve results. Respectful Collaboration - Value diverse perspectives and partnerships to achieve common goals. Empowered Development - Actively pursue professional development as a business imperative. Compensation & Benefits
Minimum $164,530.00 – Maximum $245,985.00, plus incentive opportunity. The range represents typical pay for roles in the United States and may be adjusted based on experience, skills, and internal considerations. Other compensation elements may apply according to local laws. Application Deadline
This position will be posted for a minimum of 5 business days. Company Benefits
Comprehensive medical, dental, vision, prescription drug coverage; company-provided life insurance, AD&D, short- and long-term disability; tuition reimbursement; student loan assistance; generous 401(k) match; flexible time off; paid holidays and paid leave programs, among other benefits. Equal Opportunity & Accommodation
Otsuka is an equal opportunity employer. All qualified applicants will be considered without regard to race, color, sex, gender identity or expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or other legally protected characteristics. If you require a reasonable accommodation, please contact Accommodation Request (EEAccommodations@otsuka-us.com).
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