OBJECTIVES
Lead and develop a global team of managers and scientists in the field of analytical development for late-stage synthetic molecules.
Oversee and manage late-stage analytical development for clinical trial material efforts across three main areas: Characterization and in vitro comparability
Method development and validation for release/stability
Method development for In-Process analytics
Contribute to product development and transfer from development to commercialization by collaborating with multiple functions within the Pharmaceutical Science organization.
Contribute to overall functional direction globally and represent function within CMC/Pharmaceutical Science across the global Takeda organization.
Implement and execute externalization activities with external partners and ensure completion of agreed-upon activities.
Accountabilities
Direct and indirect supervisory responsibilities in analytical areas for the development of high-quality late-stage synthetic molecules therapeutics.
Drive global late-stage team to obtain scientific data; prepare and review 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 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 stakeholders.
Manage functional area budget and human resources within required limits.
Drive continuous improvement in technology, methodology, and business processes used to support analytical development.
Maintain an active understanding of future trends in medicine.
Inspire confidence in team members and promote 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 of relevant industry experience.
Leadership experience of teams including managers and scientists.
Direct experience in analytical development for synthetic molecules, 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 synthetic molecules.
Exceptional problem-solving and troubleshooting skills related to analytical methodology.
Proven working knowledge of current GMPs, ICH guidelines, and other regulatory requirements.
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.
Other professional competencies include building authentic relationships and global communication.
Travel Requirements
Approximately 10-15% travel is required.
Takeda Compensation And Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees.
For Location
Boston, MA
U.S. Base Salary Range
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on various factors.
U.S. based employees may be eligible for various benefits.
EEO Statement
Takeda is proud of its commitment to creating a diverse workforce and providing equal employment opportunities.
Locations
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Exempt
Yes
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