Manager, CMC Management & Operations in Bernards, NJ at DSI

Date Posted: 11/11/2018

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

The qualified candidate will represent CMC development teams on global and regional cross-functional drug development project teams and will also provide project management and operational oversight of routine vendor (CXO) services. CMC development teams are accountable for the coordination and management of global and regional development candidates in both early and late phase drug development and will deliver on established project goals and timelines. This position requires a solid technical understanding of 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, clinical and commercial supply operations, and CMC regulatory and GMP compliance requirements. This position will identify, recommend and facilitate the implementation of improvements in the operational efficiency of CMC development teams across the Daiichi Sankyo organizational matrix in the Pharmaceutical Technology department. This position will require moderate supervision.

Responsibilities

1. Operational coordination and management of global and regional CMC development teams (CMC sub-teams) for multiple early and late phase drug development candidates and to facilitate the establishment of integrated global and regional CMC operational plans and oversee their execution.
2. Represent CMC development teams on global and regional cross-functional drug development project teams with a predominantly operational focus, ensure alignment of CMC operational plans with overall project plans; facilitate the timely execution of drug development project plans through proactive management of operational interfaces between the CMC development team and other functions.
3. Provide project management and operational oversight of routine vendor (CXO) services, managing contracts, timelines, budgets and deliverables, and coordinating the input of technical and functional experts as required; CXO services covered include drug substance manufacturing, drug product manufacturing and analytical testing services.
4. Facilitate regional process improvement, identifying and recommending improvements in the operational efficiency of the Pharmaceutical Technology department; participate and facilitate on cross-functional teams responsible for implementing process improvements.
5. Represent the Global Pharmaceutical Technology Unit on Alliance/Co-development operational teams for early phase projects.

Qualifications

Education
  • Ph.D. in chemistry, biochemistry, engineering or other discipline within pharmaceutical/biotechnology sciences, or a corresponding Master’s/Bachelor’s degree with a minimum of 5 years industrial experience.
Experience

The following is required:
  • At least 5 years of experience in the pharmaceutical/biotechnology industry working in a biologics drug development environment
  • Experience in biologics processing, product or analytical development activities and knowledge of CMC regulatory requirements.
  • A working knowledge of the roles, responsibilities, and operational requirements of all functions represented on CMC development teams.
  • 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.
  • Proven ability to work effectively with cross-functional stakeholders in a complex/evolving global environment.
  • Proven ability to collaborate with functional representatives to anticipate and identify project risks and develop action and resolution plans
  • Experience in regulatory strategy development, regulatory filings, and meetings with regulatory agencies, as appropriate.
The following is preferred:
  • Minimum of 1 year of experience managing CMC development teams for biologics drug development candidates, and representing those teams on cross-functional biologics drug development project teams, or equivalent.
  • Experience in the development of Antibody Drug Conjugates (ADCs).
  • Experience working within a global matrix organization.
Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All 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.