Associate Director, Product Development (Engineering)

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 external Contract Organizations to ensure timely and effective execution of related tasks.
• Provide technical project management support for all clinical drug product manufacturing activities by participating in the review and approval of batch records, release testing and stability testing results for drug products.
• Oversee and collaborate with other functions to make sure the analytical testing and release of all drug product lots in clinical development takes place at the established timeline.
• Proactively identify potential issues and develop creative solutions to technical problems in order to keep projects on schedule.
• Identify and manage process improvement activities for clinical manufacturing operations.
• Work with CMOs on the following:
  • Perform stability studies on the drug product (DP) to meet global regulatory requirements at the investigational stage.
  • In partnership with appropriate TOI function, decide on the container closure for the clinical trial materials (CTM) (Primary and secondary packaging components) and packaging operations for the CTM.
  • Manage ADC development by participating in technical business meetings and provide oversight for all development activities for antibody, conjugation, and formulation.
• Actively participate (including on-site presence) in resolution of technical issues during manufacturing and release of clinical trial material at contract sites.
• Provide technical expertise for investigating and troubleshooting OOS results.
• Coordinate and develop business processes related to the transfer of drug product processes from the development site to the manufacturing site (at CMO or to Taiho).
• Ensure proper application of regulations and guidelines International Council for Harmonisation (ICH) & GMP for the development of drug product.
• Author/review protocols, technical reports, articles and drug product portions of regulatory submissions.
• Support regulatory submissions and Health Authority (HA) requests by preparing the sections using company provided templates in the required format, writing, reviewing, and approving the specific documents.
• Provide the necessary source documents to facilitate the QA/QC of the regulatory submission components.
• Supports responses to any information request (IR) or deficiencies received from HA.

 

Education/Certification Requirements: 

• MS or PhD in Pharmaceutical Sciences, Pharmaceutics or related field or equivalent. Minimum 10 years with MS and 7 years with PhD

Knowledge, Skills, and Abilities:

• Pharma/biotech industry experience in formulation process development and drug product manufacturing preferably at a commercial level.
• Experience with preparation of drug product sections of regulatory filing documents.
• Thorough knowledge of pharmaceutics and knowledge of analytical methodologies for the testing of drug products.
• Demonstrated technical project management to guide CMO's to develop robust formulation and process.
• A proven track record in cGMP manufacturing.
• Experience reviewing and/or authoring Chemistry Manufacturing Controls (CMC) section for regulatory submissions.
• Good communication, collaboration, and problem-solving skills ensuring alignment with other functions.
• Working knowledge of injectables including lyophilization process development.
• Ability to read, analyze and interpret scientific and technical information and data.
• Good English communication skills, both verbal and written.

The pay range for this position at commencement of employment is expected to be between $183,000 - $215,000 annually. This pay range is based on the market range for positions of this type. 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, restricted stock units, commissions, 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 vacation, sick time, 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. 

#Location-Princeton,NJ #LI-Hybrid