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

Taiho is in the process of expanding its CMC development capabilities to the US. As a part of that this position is being created to open up an opportunity for an experienced analytical chemist to join a growing team that is focused on CMC development activities working with our labs/facilities in Japan and CDMOs with whom we have development contracts. This position will give the incumbent an opportunity to leverage their experience to provide oversight for analytical development for drug substance and drug products for small molecules (and biologics as portfolio evolves) in the therapeutic area of Oncology.

Position Summary

The Director, Analytical Chemistry will be responsible to provide oversight for analytical development and validation of methods for small molecule Active Pharmaceutical Ingredients (API) & Drug products (DP). All development projects are carried out entirely by outsourcing with various contract research or manufacturing organizations Contract Research Organization/Contract Manufacturing Organization (CRO/CMO) or in collaboration with Taiho Pharmaceutical Company in Japan. Candidates should possess advanced analytical chemistry skills combined with exceptional project leadership, organization, and communication skills.

Performance Objectives

• Ensure proper application of regulations and guidelines International Council for Harmonisation (ICH) & GMP for the development of methods and specifications for API & DP from early development to process validation
• Manage analytical development throughout the API and DP lifecycles
• Collaboratively work with multiple groups within the organization to support the development of request for proposals for CMOs for API and DP analytical activities
• Supervise and coordinate the development, qualification/validation and transfer of analytical methods at global CMOs to meet project timelines
• Work with CMOs to perform stability studies on the API and DP to meet global regulatory requirements at the investigational stage
• Provide technical expertise for investigating and troubleshooting Out of Specification (OOS) results and write analytical sections, and stability sections for regulatory submissions and HA requests
• Provide analytical expertise for the identification of impurities and setting up of related substance specification. In addition, collaborate with API and DP leads in setting up stage appropriate specifications for both API and DP.
• Work with API and DP leads to support assessment and control of DNA reactive impurities (ICH M7) including nitrosamines and elemental impurity risk assessment
• Represent analytical chemistry at Global CMC meetings to provide assessments, evaluations, status, issues, and other relevant technical aspects of the corresponding program
• Support regulatory submissions and Health Authority (HA) requests by preparing the sections using company provided templates in the required format, reviewing, and approving specific sections. Provide the necessary source documents to facilitate the QA/QC of the regulatory submission components
• Perform data reviews at contract labs to help define expectations and qualify new or existing contract facilities for analytical testing and regulatory inspections
• Document and track analytical methods change, specification changes, etc. by issuing development change controls
• Participate in the review and approval of release testing and stability testing results for API and DP
• Draft regulatory submissions and support exchanges with regulatory agencies

Education/Certification Requirements:

• MS or PhD, Analytical Chemistry or equivalent

Knowledge, Skills, and Abilities:

• Minimum 15 years experience with MS or 10 years experience with PhD
• Ability to work independently in a fast-paced environment
• Thorough knowledge of analytical methodologies for small molecule drug substance and drug products
• Experience handling technology transfer and technical support for analytical methods
• Experience collaborating with and overseeing CMOs and third-party manufacturers
• Experience handling analytical method validations
• Broad knowledge of regulatory and quality requirements for pharmaceutical products
• Experience reviewing and/or authoring CMC section for regulatory submissions
• Exceptional communication, collaboration, and problem-solving skills ensuring alignment with other functions
• Experience in biologics is plus

The pay range for this position at commencement of employment is expected to be between $188k and $221k annually; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as PTO, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.