Director, Flu Manufacturing Science and Technology (MSAT),
Director, Flu Manufacturing Science and Technology (MSAT), Biopharmaceutical Development
Location: Speke, Liverpool
At AstraZeneca, we 're passionate about the potential of science to address the unmet needs of patients around the world. We commit to those areas where we believe we can really change the course of medicine and bring big new ideas to life. Would you like to join us?
This is a leadership position with an opportunity to impact public health. You will lead the Flu MSAT Department and directly enable delivery of the Fluenz / Flumist (LAIV) Vaccine on an annual basis. You will provide leadership of annual influenza strain development, process development and manufacturing support, analytical development and be responsible for development of control strategy to ensure predictable and robust manufacture of product.
This position is one of exceptional scientific and process engineering complexity due to the seasonal and dynamic nature of influenza virus that is constantly evolving. Also, the need to integrate activities that span across Influenza research, development and commercial manufacturing. Though the position reports into Biopharmaceutical Development within R&D, you will also have accountability to the Site Head for the UK(Speke) Flu Manufacturing Site. You will join our UK Liverpool Site Leadership Team and play a key role in defining the values, culture, goals and growth of the site.
As a leader you will provide vision, direction and mentoring to ensure MS&T Department alignment and delivery of department objectives and Influenza franchise objectives including:
- Lead Strain Selection and Development; MVS (Master Virus Seed) process, MVB (Mono Valent Bulk) process and analytical method development, transfer and support, strain specific analytical reagent qualification and development; Lead Process and Analytical Improvements; Author Regulatory Submissions as needed; Data trending and analytics to ensure predictable manufacturing performance;
- Ensuring that the MS&T team is developing and incorporating technologies and process improvements that assures high degree of resilience within the franchise and are aligned to changing regulatory landscape
- Management (direct and indirect reports) of a large team based locally in Speke
- Being a core member of the Flumist Global Product Team accountable for strain delivery and scientific leadership within the franchise, and represent franchise in stake-holder interactions, especially with global health agencies (like WHO) and regulatory agencies
- Ensuring the team operate and align with appropriate cGMP, health and safety, timekeeping, regulatory legislative requirements and in accordance with the requirements of the Code of Conduct, quality manual and any other company policies and procedures.
- Collaboratively work to achieve strategic product supply requirement and assist in defining strategic objectives of the site and the flu franchise
- Ensuring MS&T function provides training and underpinning knowledge training on the site to improve process knowledge and understanding of the manufacturing operations
- Strategic influence of the novel cell and gene therapy R&D portfolio for AZ
Your proven and significant scientific leadership will allow you to articulate how the product will evolve and make the right plans mid and long term. We're seeking someone with background in the fields of process development, virology, analytical development, formulation development or manufacturing sciences and technology.
In addition, you will have:
- PhD or equivalent qualification and experience in biochemical engineering and/or, in a life sciences subject area (biochemistry, microbiology, virology)
- Strong team leadership and communication skills, including line management experience
- Ability to critically interpret scientific, process and analytical data
- Expertise in drug development and significant experience of interactions with regulators
- Experience in influenza R&D and/or other live virus manufacturing, or, alternatively in a different vaccine R&D/Manufacturing environment
- Knowledge and/or experience of working closely with cGMP manufacturing for clinical or commercial products
- Understanding of translational models for vaccine efficacy
- Experience in working with viral platforms such as oncolytic viruses, AAV or lentiviruses
To be considered for this role please apply today.
Full time, office based, permanent opportunity based in Speke, Liverpool.
Competitive salary and benefits apply.
Posting date: 25/03/20
Closing date: 25/04/2020
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.