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CMC Management & Operations Intern

Company: Daiichi Sankyo
Location: Basking Ridge
Posted on: January 20, 2023

Job Description:

We are currently seeking a CMC Management & Operations Intern for the Summer 2023. This full time position works for approximately 37.5 hours per week. As CMC Management & Operations Group, we support every step of CMC strategy, Manufacturing, Submission and health authority engagement through all phases of the product lifecycle: Early Development, Tech Transfer, PPQ through Commercialization. Our group is seeking summer intern interested in enhancing core knowledge and applied critical thinking skills in the CMC & Technical Operation field to develop and commercialize Daiichi Sankyo's ADCs pipeline projects. This opportunity will expose the intern to various areas of the department and provide beneficial experience and understanding of CMC principles, strategies, and processes:

  • Understand regulatory compliance/requirements of manufacturing clinical and commercialization products.
  • Support Tech Transfer of Biologics Manufacturing processes within our company's internal and external manufacturing network and Potential involvement with all phases of project management
  • Work with operations and quality groups to maintain products at a high level of performance/compliance
  • Collaborate with cross-functional teams internally and externally to improve and/or optimize CMC related business processes
  • Review completeness of documentation to support IND/BLA/MAA submissions
  • Understand manufacturing changes to ensure compliance with appropriate change control systems/process and support regulatory filing strategy (PAS, CBE, Annual Reports, etc.) Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
    • Qualified candidates must currently be enrolled in an accredited undergraduate program with a concentration in Chemical, Biochemical, Biomedical or other related Engineering disciplines, Regulatory or pharmaceutical science, or other related fields in science and technology (Chemistry, Biology, Microbiology, Operations Research, Industrial Engineering, etc.) or related field.
      • Prior experience in a corporate business environment is preferred; experience in the pharmaceutical industry is a plus.
      • Candidates must have excellent academic achievement and analytical thinking ability.
      • Candidates should have knowledge of current Good Manufacturing Practices (cGMPs), data analytics experience.
      • Candidates should have Pharmaceutical science and manufacturing process unit operation knowledge.
      • Candidates should have experience writing, editing, and reviewing scientific publications and content.
      • Candidates must have good organizational skills.
      • Candidates must have superior communication and interpersonal skills.

Keywords: Daiichi Sankyo, Newark , CMC Management & Operations Intern, Executive , Basking Ridge, New Jersey

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