Director, CMC Management & Operations in Basking Ridge, New Jersey at DSI

Date Posted: 10/23/2019

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years and Counting!

With over 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. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

Job Summary:

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 support the activities of global and regional senior management within the Global Pharmaceutical Technology function. Responsible for managing chemistry, manufacturing and control (CMC) activities to support US and International drug development programs. The Director will provide knowledge-based leadership, coordination and management for multiple projects to expedite successful product development and regulatory approvals. This position will oversee CMC development strategies and operational plans across a portfolio of projects and ensure that they are aligned with the strategic and operational objectives of the Global Pharmaceutical Technology function and those of the R&D, Commercial and Supply Chain functions. This position will represent the Global Pharmaceutical Technology function on external industry, academic and regulatory groups. Demonstrated experience in process chemistry or formulation development.

Responsibilities:
  • Provide 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.
  • 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.
  • Provide leadership, performance management and mentorship for a group of technical leaders and technical project managers whose primary responsibilities are to develop, implement and oversee global and regional CMC development strategies and operational plans that are integrated with the strategies and plans of the R&D, Commercial and Supply Chain functions represented on drug development project teams. Apply sound scientific judgment to address development challenges and delays.
  • Make decisions on prioritization, budgets and resource allocation for the CMC Management & Operations function across a portfolio of development projects. Recommend and implement strategies for project accelerations without risk to quality.
  • Participate as the Global Pharmaceutical Technology function representative 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 for both early and late phase projects.
  • Actively participate on global and regional cross-functional drug development project teams, representing CMC Development with both a strategic and operational focus, and to support the activities of global and regional senior management within the Global Pharmaceutical Technology function; 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.
Qualifications
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:
  • Ph.D. in chemistry, biochemistry, or other discipline within pharmaceutical/biotechnology sciences or a B.S./M.S. with relevant experience.
  • At least 5 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.
  • Proven ability to lead, manage and mentor a function comprised of technical leaders.
  • Experience in process, product and analytical development activities and a strong knowledge of global CMC regulatory requirements.
  • At least 3 years of 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.
  • Experience in bringing development candidates through late stage clinical development, filing, approval, and commercialization. Experience in filing a Biologics License Application (BLA).
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.