Associate Director, Product 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: 

This is a new and exciting role as part of growing CMC group at Taiho.

You will be responsible not only for product development but also support clinical studies, commercialization and life-cycle management.

You will have an opportunity to showcase your innovativeness in drug delivery and bringing therapies to patients with un-met medical needs.

As an integral part of our team, you will have the opportunity in advancing monotherapy or fixed-dose combination therapies to commercial stage in an organization that provides culture for both your personal and professional growth.

If you are seeking a highly visible role to make a long-lasting impact in the oncology space this is the role for you.

Position Summary: 


* The Associate Director, Product Development will be responsible for product development, scale up, technology transfer, manufacturing of Good Manufacturing Practice (GMP) batches of clinical-stage solid oral products.

Under minimal supervision this position will be responsible for managing the studies and manufacturing batches at the Contract Manufacturing Organization (CMO) partners.

Also responsible for designing the development studies and manufacture of clinical batches.

Successful candidate will need pharmaceutics knowledge, organization skills, and good communication skills.

Performance Objectives:


* Overall responsibility for global drug product development of fixed-dose, solid, oral products


* Work with CMO to design studies to develop a robust formulation and process for these products.


* Transfer the technology from clinical-stage CMO to commercial CMO or internal teams within Taiho, as necessary.


* Responsible for continuous improvement throughout drug product manufacturing, may include support for process validation up to commercialization.


* Support cross-functional project teams and work closely with Quality Assurance, Regulatory as well as ...