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

Date Posted: 11/23/2019

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 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. This position will also provide project management and operational oversight of multifaceted vendor (CXO) services, and collaborate cross-functionally to identify, recommend and lead the implementation of improvements in the operational efficiency of the Pharmaceutical Development department. This position will require moderate supervision.

Responsibilities:
  • Operational leadership and management, and strategic facilitation and management, of global and regional CMC development teams (CMC subteams) for multiple drug development candidates across all phases of development; facilitate the establishment of integrated global and regional CMC development strategies, lead the establishment of integrated global and regional CMC operational plans, and oversee their execution.
  • 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 plans that optimally integrate the CMC operational plans with those of other functions, and ensure alignment of CMC development strategies with overall project strategies; recommend improvements in drug development project plans.
  • Provide project management and operational oversight of multifaceted vendor (CXO) services, managing contracts, timelines, budgets and deliverables, and managing 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.
  • Lead regional process improvement, identifying and driving improvements in the operational efficiency of the Pharmaceutical Development department; collaborate across operational interfaces with other functions within DSI (e.g. CSO, QA, RACMC, TMCP, Clinical Development, SC etc.) to refine existing processes and identify and implement new processes as required.
  • Represent the Global Pharmaceutical Technology Unit on Alliance/Co-development strategy teams for early phase projects, and operational teams for both early and late phase projects
Qualifications
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:
  • PhD in chemistry, biochemistry, or other discipline within pharmaceutical/biotechnology sciences, or a corresponding Masters/Bachelors degree with 7 years industry experience.
  • At least 5 years experience in the pharmaceutical/biotechnology industry working in the drug development environment required.
  • Experience in process, product or analytical development activities, and a knowledge of CMC regulatory requirements required.
  • At least 2 years experience leading CMC development teams for drug development candidates and representing those teams on cross-functional drug development project teams, or equivalent required.
  • Experience working within a global matrix organization preferred.
Ability to travel global and domestic up to 25%

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.