Sr. Scientist/Associate Director, RACMC Pharma Tech in Bernards, NJ at DSI

Date Posted: 1/7/2022

Job Snapshot

Job Description

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. In addition to a strong portfolio of medicines for cardiovascular diseases, 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.

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.

Provide regulatory guidance and strategy on CMC development activities to Project Teams and other functional teams leading to sound scientific development programs and successful registration for new biological products.

Determine the CMC documentation requirements for regulatory submissions as well as evaluate submission documents for accuracy and consistency. Represent Daiichi Sankyo during FDA interactions; be able to schedule, coordinate and lead meetings with FDA and prepare company personnel for FDA meetings. Coordinate and prepare regulatory responses to questions and information requests from health authorities.

Experience or expertise in any one of the following CMC functions is required:

  • Manufacturing or process development of monoclonal antibodies, proteins or other large molecules
  • Formulation development or manufacturing of biological drug products
  • Analytical development of biologic compounds

Responsibilities

  • Organize and manage the preparation (content and format) of all types of submissions to FDA, especially IND’s and BLA’s. Coordinate activities required for timely and accurate reporting of information updates to existing submissions.
  • Facilitate and support liaison activities with functional groups within Daiichi Sankyo Pharma Development and Corporate partners as related to assigned products/project areas.
  • Provide regulatory support and guidance to enable high-quality and timely regulatory submissions
  • Keep current with Regulatory guidelines and assists in educating the organization on evolving Regulatory Affairs CMC (RACMC) issues and regulations. Promotes global RACMC services to CMC Operations, Pharmaceutical Development, Clinical Supplies’ Operations, Clinical Regulatory and other development functions within the organization.
  • Supervise the identification and compilation of required documentation for submission. Prioritizes workload.
  • Evaluate content and adequacy of submission documents, to identify potential deficiencies and provide recommendations to address the deficiencies.

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

Education and Experience

M.S. in a scientific discipline with 8-12 years pharmaceutical industry experience with a minimal of 4+ years direct or related CMC regulatory experience

or

PhD. in a scientific discipline with 6-10 years pharmaceutical industry experience and a minimal of 4+ years direct or related CMC regulatory experience.

Successful track record in preparation, management of review and approval of NDA/BLA with FDA.

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.

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.