OBJECTIVES:
- Lead and develop a team of managers and scientists and their teams in the field of analytical development in the field of late stage biologics.
- Oversee and manage phase-appropriate analytical development for clinical trial material efforts across three main areas: a) Characterization and comparability, b) Method development of methods for non-routine and release/stability use, c) Method development for In-Process analytics across all required analytical techniques (including but not limited to HPLC, mass spectrometry, immunological and potency assays).
- Contribute to product development from Pharmaceutical Sciences to Commercialization by collaborating with multiple functions within the Pharmaceutical Science organization to improve analytical, process and product knowledge, including transfer of development assets to the commercial organization.
- Contribute to overall functional direction globally and represent function within CMC/Pharmaceutical Science and across the global Takeda organization.
- Implement and execute externalization activities with external partners, facilitate development of execution plans for each, and ensure completion of agreed upon activities.
ACCOUNTABILITIES:
- Direct and indirect supervisory responsibilities in analytical areas for development of high-quality late stage biologics therapeutics (complex proteins, ADCs, mAbs, engineered mAbs).
- Drive global late stage team to obtain scientific data; data compilation and review; preparation and review of technical reports, global regulatory filings, and other documentation; project/CMC team representation/leadership; technical interactions with internal partners and contract laboratories.
- Collaborate with other functions in Pharmaceutical Sciences to encourage strategic alignment and successful achievement of shared goals.
- Be well versed in all stages of analytical development and understand the global regulatory trends for CMC activities, to ensure robust and high-quality regulatory filings in all major countries.
- Develop, implement and execute a smart sourcing strategy.
- Lead global CMC key initiatives and represent Pharmaceutical Science to other cross functional stakeholder key initiatives.
- Manage functional area budget and human resources to be within required limits.
- Drive continuous improvement in the technology, methodology and business processes used to support analytical development, characterization and associated operational and documentation systems.
- Strong knowledge of ICH and other regulatory guidelines including Quality by Design.
- Maintain an active understanding of the future trends of medicine to build an organization adaptable for the future.
- Inspire confidence in team members and lead the organization culture, promoting a healthy and inclusive working environment.
- Build future leadership while mentoring direct reports and junior employees.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Master or PhD in chemistry, biology, pharmacy, or related pharmaceutical science; at least 10 years relevant industry experience including significant experience in analytical science, cGMP compliance, CMC regulatory requirements in multiple analytical development areas.
- Leadership experience of teams including managers and scientists. Development of team members to managers of scientific analytical teams including individual contributors with an exceptional commitment to science.
- Direct experience in analytical development for biologics, especially late stage assets, and ability to drive study completion in a timely, sustainable, robust and cost-efficient manner.
- Drive decision making within a cross-functional, cross-cultural global team structure.
- Knowledge and experience with product development and clinical supply processes and product commercialization. Quality experience is of advantage.
- Experience in reviewing and approving analytical-related CMC sections of IND/IMPD and BLA/MAA regulatory submissions. Knowledgeable in European, Japanese, Chinese and US CMC regulatory requirements for Biologics.
- Deep and broad knowledge of analytical chemistry of biologics in support of drug substance and drug product release and stability method development, raw material control, in process control, and characterization.
- Exceptional problem solving and troubleshooting skills related to analytical methodology.
- Proven working knowledge of current GMPs, ICH guidelines including Quality by Design, other regulatory requirements, and various quality systems.
- Proven knowledge, skills, and abilities with statistical analysis (with emphasis on analytical testing applications).
- Knowledge of complex and state-of-the-art methodology for biologics GMP method development and characterization.
- Proven ability to work efficiently and effectively as a leader of managers and scientists.
- OPEX and CAPEX budget planning and controlling skills and efficient resource planning.
- Strong verbal, presentation, and written communication skills. Can concisely articulate and deliver effective presentations on complex technical issues to non-technical audiences.
- Ability to create collaborative and trusting relationships internally and with external partners.
- Requires strong organizational skills and attention to detail for composing and proofing materials, scheduling, establishing priorities, and meeting deadlines.
TRAVEL REQUIREMENTS:
- Approximately 10-15% travel is required, including domestic and international flights with overnight stays.
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