Head of Research And Development

2 weeks ago

Hsinchu County, Taiwan Cenra Inc. 中化控股 Full time NT$1,200,000 - NT$3,600,000 per year

Position Summary

The R&D Head is responsible for the oversight for all research and development activities of the organization. This person is accountable for successful development of new products and serves as subject matter expert from early development through registration.

Responsibilities

  1. Responsible for all aspects of research and development activities from project initiation to development to scale up and commercialization, including technical and process details
  2. Co-own and develop product development concept with marketing department based on market needs and technical capabilities
  3. Oversee and manage pre-formulation, formulation development, stability & compatibility studies, bio-analytical characterization, and pharmaceutical testing
  4. Lead scale up and tech transfer of manufacturing process
  5. Collaborate with manufacturing department to drive process improvement and cost
  6. optimization
  7. Compile and prepare required documents such as protocols, patents, and literature reviews
  8. Provide strategic recommendations and technical support to other departments on regulatory submission and product launches
  9. Drive strategic initiatives to improve the efficiency and productivity of the R&D organization including R&D performance management and in-licensing of assets
  10. Build scientific and technical capabilities of the R&D organization

Qualifications

  1. Postgraduate degree (MSc / PhD) in Chemistry, Biology, Pharmacy, Chemical
  2. Engineering or relevant field
  3. Minimum 10 years of relevant experience across analytical science, cGMP compliance, CMC regulatory requirements in multiple pharmaceutical development areas (analytical and formulation development)
  4. Extensive working knowledge of GxP practices, requirements of leading pharmacopoeias, TFDA and PMDA guidelines, ICH guidelines, other regulatory standards, and various quality system
  5. Current knowledge of industry trends and best practices in generic R&D
  6. Broad experience in analytical and formulation development and successful delivery across a range of small molecule drugs through all stages of development
  7. Prior leadership and project management experience of cross-functional teams including scientists and managers in and outside of R&D organization
  8. Prior experience in corporate-wide transformation preferred

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