Head, Analytical Development Biologics – Late Stage Leader

vor 2 Monaten

Wien, Wien, Österreich Takeda Vollzeit
Job Summary

We are seeking a highly experienced and skilled Senior Director to lead our Analytical Development Biologics team in the Late Stage. As a key member of our Pharmaceutical Science organization, you will be responsible for driving the development of high-quality late stage biologics therapeutics.

Key Responsibilities
  • Lead and develop a team of managers and scientists in the field of analytical development for late stage biologics.
  • Oversee and manage phase-appropriate analytical development for clinical trial material efforts across three main areas: characterization and comparability, method development for non-routine and release/stability use, and method development for In-Process analytics.
  • 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.
  • Represent the 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.
  • 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.
  • 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.
Requirements
  • Master or PhD in chemistry, biology, pharmacy, or related pharmaceutical science.
  • At least 10 years of 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, with a focus on developing team members to managers of scientific analytical teams.
  • 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.
  • 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.
  • Develop, implement, and execute a smart sourcing strategy.
  • 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.
  • 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.
  • Other professional competencies include building authentic relationships, global and cross-boundary communication, excellence in execution, courage to challenge, inspiring and motivating others.

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