Associate Director, Lyophilization Steward

Associate Director, Lyophilization Steward


Primary Responsibilities

  • Serve as the subject matter expert for Lyophilization process technology throughout the GAHM organization.
  • Collaborate as needed with research, process development, and internal/external manufacturing sites to support New Product Introductions, enabling on-time, right-first-time technology transfers.
  • Serve as the single point of technical governance to the Research & Development, Value Chain/Supply Chain Management, Manufacturing Operations and Commercial/Marketing groups to manage all technical aspects pertaining to Lyophilization process technology.
  • Build and maintain strong and trusting relationships with R&D Species Leaders, Value Chain Leaders, site leaders, functional management, and other stakeholders to ensure effective communication of plans and issues.
  • Stay abreast of scientific developments and trends in Lyophilization process technology and participate in external industry/regulatory forums in order to maintain an industry-leading level of subject proficiency.
  • Provide technical/scientific guidance and oversight to project teams that are doing process changes, process improvements or technology transfers involving Lyophilization process technology.
  • Provide technical/scientific guidance to major investigations related to Lyophilization, for example, investigations related to yield declines or stability trends
  • Establish company “best practices” and standards where appropriate as related to Lyophilization process technology.
  • Develop recommendations and options for Lyophilization process improvements.

Education Minimum Requirements

  • Bachelor’s degree in a technical or scientific discipline such as Biology, Chemistry or Engineering
  • Preferred: PhD or advanced degree with specialization in a subject pertinent to vaccine/large molecule manufacture

Required Experience and Skills

  • At least seven years of relevant work experience in the pharmaceutical, biotech, or related industry
  • Commercial processes experience for vaccines/large molecules/small molecules is required, either in development or in technical support
  • Demonstrated problem solving, effective verbal and written communication
  • Strong scientific understanding of vaccine and/or biologic products and/or small molecule processes and their effective integration with relevant regulatory/GMP requirements
  • Ability to collaborate effectively, across functional boundaries, to align stakeholders and sponsors on technical strategies
  • Proficiency with pharmaceutical industry technical business processes, i.e. change control, deviation management, technical protocols/reports, and regulatory license documents

Apply through the link below;

https://jobs.merck.com/us/en/c/manufacturing-quality-assurance-jobs

Skills

Posted on

April 28, 2021