Associate Director, MSAT - Analytical Sciences (Biologics)

Remote

Full time

R11173

Position Summary

The Associate Director of MSAT (Manufacturing Science & Technology) - Analytical Sciences will serve as a scientific and technical leader supporting tech transfer, and commercial manufacturing of biologic drug substances and drug products. This role oversees analytical lifecycle management, method qualification/validation, comparability, control strategy implementation, and investigations. The ideal candidate brings deep expertise in biologics analytics, strong cross-functional leadership, and experience working with external contract manufacturing companies.

Key Responsibilities

• Lead the analytical sciences function within MSAT to ensure robust support for commercial manufacturing of biologics (e.g., mAbs, fusion proteins).

• Drive analytical control strategy, specification setting, and lifecycle management in alignment with QbD principles.

• Oversee method performance monitoring and trending, analytical capability assessments, and continuous improvement initiatives.

• Provide analytical subject matter expertise (SME) during technology transfers to external manufacturing sites.

• Support manufacturing investigations by leading root-cause analyses, interpreting analytical data, and defining corrective and preventive actions.

• Guide method troubleshooting, resolution of OOS/OOT trends, and process-product linkages (CQA-CPP relationships).

• Lead analytical method qualification/validation strategy to meet Phase-appropriate and commercial requirements.

• Author, review, and approve analytical sections of regulatory filings (BLA/MAA, responses to agency queries).

• Partner with QA, Regulatory, and MSAT to ensure compliance with global regulatory guidelines (ICH Q2, Q6B, Q14, etc.).

• Partner closely with Process Development, Quality Control, Quality Assurance, Regulatory teams.

• Drive analytical readiness for tech transfers, PPQ readiness, comparability assessments, and lifecycle changes.

• Lead external oversight of CDMOs/CROs, ensuring analytical deliverables, timelines, and quality expectations are met.

• Ensure data integrity and proper scientific documentation across MSAT analytical activities.

Qualifications

Required

• PhD or MS in Analytical Chemistry, Biochemistry, Molecular Biology, Chemical Engineering, or related field.

• 8 + years (PhD) or 12+ years (MS) of experience in analytical development, QC, or MSAT for biologics.

• Demonstrated technical expertise in analytical methods for biologics (e.g., HPLC/UPLC, CE, LC-MS, bioassays, ELISA, spectroscopy).

• Strong experience in commercial biologics manufacturing support, tech transfer, and method lifecycle management.

• Deep knowledge of global regulatory expectations for biologics (ICH Q5, Q6, Q8, Q14; FDA and EMA guidance's).

• Proven leadership skills and experience managing teams or cross-functional technical groups.

• Experience with commercial biologics PPQ and BLA/MAA submissions.

• Expertise in statistical tools (e.g., JMP, Minitab) and digital data systems (e.g., LIMS)

• Experience working with CDMOs/CROs and external manufacturing partners.

• Strong understanding of CQAs, control strategy development, and analytical-process integration.

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 $169,222.00 - Maximum $253,000.00, 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; .

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.

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Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." In the U.S., Otsuka is comprised of two companies, Otsuka America Pharmaceutical, Inc., and Otsuka Pharmaceutical Development & Commercialization, Inc., that share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and digital medicine.

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OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023.

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