Senior Manager, Analytical Development – Small Molecules

🕒 July 8

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Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

Pharmaceuticals • Healthcare • Biotechnology

Otsuka Pharmaceutical Companies (U. S. ) is a prominent player in the pharmaceutical manufacturing industry, dedicated to creating innovative products for better health worldwide. The company comprises two main entities: Otsuka America Pharmaceutical, Inc. (OAPI), which is focused on commercializing Otsuka-discovered and in-licensed products in North America, and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), which specializes in the clinical development and global registration of innovative healthcare solutions, particularly in the field of neuroscience.

📋 Description

• Provide strategy and technical expertise to oversee analytical activities at third party laboratories • Collaborate cross-functionally to drive scientific excellence and ensure compliance • Lead analytical activities such as method development, optimization and transfer • Provide actionable insights and recommendations to optimize project outputs • Monitor progress, identify potential risks, and implement appropriate mitigation strategies • Lead the development and implementation of scientific strategies • Manage pharmaceutical stability studies, including protocols and timelines • Author technical reports and CMC sections in regulatory documents • Mentor and train team members.

🎯 Requirements

• 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.

🏖️ 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 • Paid leave programs as well as other company provided benefits.