Senior Manager, Analytical Development

Role Description

This role provides strategy and technical expertise to oversee analytical activities at third party laboratories, including:

• Method development/validation/qualification
• Stability testing
• Investigational testing

In addition, there is responsibility to provide regulatory support from early phase drug development to commercial with technical aspects by developing analytical tools to gain understanding of key quality attributes in product and process for early to late phase synthetic small molecule, synthetic peptide, and/or other modalities.

Collaborate cross-functionally with:

• Analytical team members
• Drug substance and drug product process development colleagues
• Regulatory affairs
• Quality assurance
• Other departments

Lead analytical activities such as:

• Method development, optimization, and transfer for synthetic small molecules testing and characterization at CMO or contract testing labs

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.

Lead the development and implementation of scientific strategies, ensuring alignment with regulatory requirements and industry best practices in the pharmaceutical field.

Provide analytical data to support drug substance and drug product development, including:

• Purity analysis
• Chiral purity
• Structure elucidation using mass spectrometry

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.

Author technical reports and Chemistry, Manufacturing, and Controls (CMC) sections in regulatory documents.

Mentor and train team members, fostering their professional growth and expertise in pharmaceutical analytical testing.

Qualifications

• 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

Requirements

• Ability to prioritize and manage multiple projects simultaneously, meet deadlines, and adapt to changing priorities in a dynamic environment
• Possess effective project management skills
• Sound judgement, decision-making skills, negotiation skills, and good organizational skills
• Experience in the pharmaceutical or biotech industry, focusing on process and product development, and analytical method development for drug substances and products
• Strong understanding of small molecule analysis and structure elucidation informed by knowledge of organic chemistry
• Hands-on experience in method development, characterization, and analytical control strategy, especially having mass spectroscopy (MS) experience
• Proficiency in a broad spectrum of structure elucidation and physiochemical techniques including MS, UV, NMR, FTIR, etc.
• Familiarity with USP monographs and chapters, and ICH/FDA guidance documents related to analytical method transfer and validation, impurities, mutagenic impurities, etc.
• Ability to work effectively in cross-functional teams, and across various geographic locations in different time zones
• Excellent technical writing skills with attention to detail in authoring methods, specifications, technical reports, and regulatory filing documents

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
• Other company provided benefits

Come discover more about Otsuka and our benefit offerings;