Sr. Manager, Analytical Development

Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers.

Our “People first” approach means we also highly value our employees, who work relentlessly to help execute our mission.

Taiho’s success is founded on ensuring we always act with accountability, collaboration, and trust.

By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other.

Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients.

Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients.

It’s our work, our passion, and our legacy.

We invite you to join us.

Hybrid

Employee Value Proposition:

Join our team at Taiho Oncology where innovation thrives, and excellence is celebrated.

As a Senior Manager in Analytical Development, you'll play a pivotal role in driving scientific breakthroughs and shaping the future of our industry.

At Taiho, we prioritize collaboration, creativity, and continuous learning, providing you with the resources and support you need to excel in your role.

With competitive compensation, a supportive work culture, and opportunities for career growth and advancement, Taiho is more than just a workplace – it's a community of passionate professionals dedicated to making a difference.

Join us and unlock your full potential as a leader in analytical development.

Position Summary:

The Sr.

Manager, Analytical Development is responsible for all aspects of Analytical Development related to drug substance and drug product, serving as analytical lead for assigned projects with the CMC team.  Liaises with CMOs to ensure methods are developed and qualified to meet regulatory requirements, interacts with QA/Regulatory/CMC to set specifications, and ensures batches are tested and released to meet project timelines and clinical needs.

Performance Objectives:


* Serves as analytical lead for drug substance/drug product for a drug development project, accountable for analytical deliverables according to project needs and stage of development.


* Ensures phase-appropriate methods are developed and validated ahead of batch manufacture and testing through development of drug substance and drug product.


* Ensures all required analytical testing of drug substances and drug products in clinical development is completed according to agreed timelines.


* Collaborates with relevant cross functional teams to set product specification and assign shelf life.


* Performs technical review of batch release and stability data for drug substances, and drug products.


* Reviews ...