This is primarily a site based role where the focus of the individuals attention will be on
- Supporting the site GMT team in New Product Introductions(NPI) from VMRD into the site,
- Technology Transfers of current processes from one site to another within the network
- Support manufacturing teams in maintaining and improving the performance of viral vaccine production
This position typically requires at least 5 years of experience in a biological or biopharma manufacturing or research environment, hence the expectation is that the individual will apply their technical skills and knowledge independently and work on multiple NPI’s, manufacturing transfer projects and/or continuous improvement projects in parallel.
You will be a member of multiple new product introduction team’s (NPI), where you will be responsible for:
- Working closely with VMRD to co-develop new products suitable for transfer into the production facility
- Understanding the capacity of your current facility and what would be needed to process fit a new product
- Identify constraints in the product in development and make suggestions for improvements to facilitate the scale up and commercial manufacture of a process
- Be a member of the site transfer team to transfer the process into manufacturing
- Take accountability for transferring the process “as is” from VMRD into manufacturing
- Train production personnel on the new process and ensure knowledge of the process is passed onto production teams
- Support manufacturing in preparing batch records for new products
You will be a member of the site to site technology transfer teams where you will be responsible for the
- Assessment of the process or analytical gaps in the sending and receiving site
- If a member of the sending site provides technical support to receiving site
- Potentially travel to receiving site to support transfer of knowledge
You will work on a number of continuous improvement projects to support the sites priorities
- Develop process control charts for the appropriate antigen and vaccine processes
- Take ownership and champion the performance of a range of antigen manufacturing processes
- Identify process improvements that result in improved supply reliability, reduction in zero yields, reduction in scrap, improvement in process yields
- Support Procurement in sourcing alternative raw material and component suppliers to help reduce cost for the site
Provide Technical support to immediate site investigations that may have an impact on supply of product to the market Investigate new technologies and implement changes to site where beneficial
Education and Experience
BS or MS in a life science, (virology, bacteriology or immunology), related engineering, or equivalent biological experience is required. Demonstrated competency in process and analytical methods development, process/cleaning validation, cell culture, and media optimization. This position requires a minimum of 5 years process or analytical development experience
Previous experience in developing and scaling up mammalian cell culture processes and bioreactor experience is highly desirable.
Technical Skills and Competencies
- Laboratory and/or manufacturing experience in biological manufacturing and/or testing is highly desirable. A working knowledge of vaccine production methods and experimental design and experience in GLP or GMP is also desirable.
- Basic knowledge of USDA and EU regulatory systems desired.
- Strong technical/analytical skills and possess a high degree of personal motivation.
- Strong oral and written communication, excellent interpersonal skills, and ability to interact across divisional boundaries.
- Strong commitment to product quality, continuous improvement and working knowledge of RFT (Right First Time) and Lean principles.
- Strong commitment to customer service.