Job Description
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.
- 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.
- 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.
- 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.
- Strong knowledge of ICH and other regulatory guidelines including Quality by Design.
- Maintain an active understanding of the future trends of medicine.
- 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.
- Leadership experience of teams including managers and scientists.
- Direct experience in analytical development for biologics, especially late stage assets.
- Drive decision making within a cross-functional, cross-cultural global team structure.
- Knowledge and experience with product development and clinical supply processes.
- Experience in reviewing and approving analytical-related CMC sections of regulatory submissions.
- Deep and broad knowledge of analytical chemistry of biologics.
- Exceptional problem solving and troubleshooting skills related to analytical methodology.
- Proven working knowledge of current GMPs, ICH guidelines including Quality by Design.
- Proven knowledge, skills, and abilities with statistical analysis.
- Knowledge of complex and state-of-the-art methodology for biologics GMP method development.
- Proven ability to work efficiently and effectively as a leader.
- 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.
TRAVEL REQUIREMENTS:
- Approximately 10-15% travel is required, including domestic and international flights with overnight stays.
Locations: Boston, MA; Vienna, Austria
Worker Type: Employee
Worker Sub-Type: Regular
Time Type: Full time
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