Senior Manager, Analytical Development – Small Molecules

🔥 39 minutes ago

🇺🇸 United States – Remote

💵 $134.6k - $201.3k / year

⏰ Full Time

🟠 Senior

👔 Manager

👻 Ghost score 0%

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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

• Develop strategy and provide technical expertise overseeing analytical activities at third-party laboratories • Oversee method development, validation, qualification, stability testing, and investigational testing • Provide regulatory support from early-phase drug development through commercial stages • Develop analytical tools to understand key quality attributes in products and processes across synthetic small molecules, synthetic peptides, and other modalities • Collaborate with analytical, drug substance and drug product process development, regulatory affairs, quality assurance, and other departments • Lead method development, optimization, and transfer for synthetic small molecule testing and characterization at CMOs or contract testing laboratories • Provide actionable insights and recommendations based on analysis of analytical projects, including logistics, budgeting, method development, release testing, and reporting • Monitor progress, identify risks, implement mitigation strategies, and align work with strategic objectives • Lead development and implementation of scientific strategies aligned with regulatory requirements and industry best practices • Provide analytical data supporting drug substance and drug product development, including purity analysis, chiral purity, and structure elucidation using mass spectrometry • Manage pharmaceutical stability studies, protocols, and timelines for IND and NDA activities • 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 plus 10 years of work experience, or a Ph.D. in analytical science, chemistry, or related science plus 5 years of work experience • 10 years of work experience with a bachelor’s or master’s degree, or 5 years with a Ph.D. • Work experience in a GxP environment focused on analytical laboratory testing of pharmaceuticals and related materials • Strong leadership, communication, and interpersonal skills • 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 • Excellent oral and written communication skills • Ability to prioritize and manage multiple projects, meet deadlines, and adapt to changing priorities • Effective project management skills • Sound judgment, decision-making, negotiation, and organizational skills • Experience in pharmaceutical or biotech industry, process and product development, and analytical method development for drug substances and products • Strong understanding of small molecule analysis and structure elucidation informed by organic chemistry • Hands-on experience in method development, characterization, and analytical control strategy, especially mass spectrometry experience • Proficiency in structure elucidation and physicochemical techniques including MS, UV, NMR, and FTIR • Familiarity with USP monographs and chapters and ICH/FDA guidance documents • Ability to work effectively in cross-functional teams and across geographic locations and time zones • Excellent technical writing skills • Bachelor’s or master’s degree plus 10 years’ experience, or Ph.D. plus 5 years’ experience in a GxP environment

🏖️ Benefits

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