- 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
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