Senior Program Lead / Director - CMC

Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Summary

This position will represent DSI in global Chemistry, Manufacturing and Controls (CMC) development activities for Daiichi-Sankyo new drug substances and drug products and provide scientific guidance and technical input to integrated drug development programs. The Senior Program Lead will provide knowledge-based leadership, coordination and management of global and regional CMC development teams (CMC subteams) across the Daiichi Sankyo organizational matrix for multiple early and late phase drug development candidates. This position will represent CMC development teams on global and regional cross-functional drug development project teams with both a strategic and operational focus, and to global and regional senior management within the Global Pharmaceutical Technology Unit. The Senior Program Lead is a subject matter expert for CMC development within the Global Pharmaceutical Technology Unit, representing the Unit on due diligence teams and external industry groups, providing project leadership and technical oversight of multifaceted vendor (CXO) services, and collaborating cross-functionally and cross-regionally to identify, recommend and lead the implementation of improvements in the operational efficiency of the Unit. This position will require minimal supervision.

Responsibilities

- Strategic and operational leadership and management of global and regional CMC development teams (CMC subteams) for multiple drug development candidates across all phases of development; lead the establishment of integrated global and regional CMC development strategies and operational plans and oversee their execution; accountable for the technical output of CMC development teams.

- Represent CMC development teams on global and regional cross-functional drug development project teams with both a strategic and operational focus, and to global and regional senior management within the Global Pharmaceutical Technology Unit; ensure the establishment of drug development project strategies and operational plans that optimally integrate the CMC development strategies and operational plans with those of other functions in order to expedite successful product development, regulatory approvals and commercialization ; recommend improvements in drug development project strategies and plans.

- Provide project leadership and technical oversight of multifaceted vendor (CXO) services, managing business relationships, and leading cross-functional teams of technical and functional experts as required; CXO services covered include drug substance process development and manufacturing, drug product formulation development and manufacturing, analytical methods development and validation, technology transfer and scale-up, process characterization and validation.

- Research, advise and exchange technical information and best practices for CMC development within the Global Pharmaceutical Technology Unit; identify and drive improvements in the global operational efficiency of the Unit; collaborate across operational interfaces with other functions and regions to refine existing processes and identify and implement new processes as required; make recommendations for improvements in global strategy.

- Represent the Global Pharmaceutical Technology Unit on due diligence teams, coordinating the input of global technical and functional experts as required; make recommendations to Business Development and senior management within the Global Pharmaceutical Technology Unit.

- Represent the Global Pharmaceutical Technology Unit on Alliance/Co-development strategy teams and operational teams for both early and late phase projects.

- Represent the Global Pharmaceutical Technology Unit on external industry, academic and regulatory groups.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education Qualifications (from an accredited college or university)

- PhD in biochemistry, (bio) chemical engineering, chemistry, or other discipline within pharmaceutical/biotechnology sciences preferred

- PharmD with a minimum of 6 years industrial experience preferred

- Master's Degree with a minimum of 9 years industrial experience preferred

- Bachelor's Degree with a minimum of 12 years of industrial experience required

Experience Qualifications

- 7 or More Years of experience in the pharmaceutical/biotechnology industry working in CMC development; demonstrated experience in taking a leading role in the preparation, filing and approval of multiple NDAs/BLAs required

- 1 or More Years of experience as a matrix lead of a CMC development teams for drug development candidates and representing those teams on cross-functional drug development project teams, or equivalent. required

- A working knowledge of the roles, responsibilities, and operational requirements of all functions represented on CMC development teams. required

- Demonstrated matrix management skills and clear ability to influence and effectively align, motivate and empower the team to progress project goals in a cross-functional team environment. required

- Proven ability to work effectively with cross-functional stakeholders in a complex/evolving global environment. required

- Proven ability to collaborate with functional representatives to anticipate and identify project risks and develop action and resolution plans required

- Experience in the development of Antibody Drug Conjugates (ADCs). preferred

- Experience working within a global matrix organization. preferred

- Experience leading CMC drug development teams to progress clinical candidates and representing those teams on cross-functional drug development project teams in a global setting, or equivalent preferred

Travel

Ability to travel up to 20% Communications (electronic and teleconference/video-conferencing) across all global time zones, global and domestic travel required.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.