Senior Scientist / Principal Scientist - Cell and Gene Therapy - BPD
This position is recruiting for either the Senior Scientist or Principal Scientist level. The candidate will have responsibility for developing processes for formulation and filling of biologics in vials and syringes, as well as manufacturing processes required for cell and gene therapies or inhaled biologics.
Primary responsibilities will include:
1) Technical Leadership: Drive a culture of innovation, scientific strength and technical rigor within Development teams. Provide technical and strategic leadership to project teams, junior staff, and the broader Development organization. Drive strategic thinking on drug product and novel therapeutic development teams by providing knowledgeable input on design for manufacturing, equipment vendor selection, manufacturing site capabilities, project lead time and budget estimates. Ensure that AstraZeneca is a leader in the industry by being active in the external biologics manufacturing development and devices community through, for example, presenting at major conferences, participation in industry consortiums. May manage direct reports.
2) Process Design and Development: Provide technical rigor and a lifecycle validation mindset in process design and development. Evaluate, select, and implement new manufacturing technology that drive better quality and operational advantages. Specify requirements of manufacturing equipment and support equipment design and build. Lead Quality Risk Management efforts on projects, develop risk-based characterization and validation strategies for manufacturing processes. Propose general working strategies and risk-based project strategies that meet requirements of product quality, microbial control and sterility assurance, cGMP, as well as timeline and budget constraints. Develop pilot laboratory capabilities required for novel therapies (e.g. cell and gene therapy).
3) Tech Transfer and Validation: Lead late-stage and commercial technical transfers to internal facilities and contract manufacturers. Organize an internal sending unit team including development functions (device, analytical, packaging, formulation, fill and assembly process SMEs), supply chain, project management and QA. Ensure correct implementation of control strategies into manufacturing records. Design and oversee validation activities for equipment and manufacturing processes. Manage timelines and activities internally, communicate goals and oversee successful delivery at the receiving site. Some travel (5-15 trips per year) in the US and abroad is required.
A degree in mechanical, chemical, or pharmaceutical engineering, chemistry, materials science, or a related engineering or pharmaceutical science field.
Senior Scientist: BS and 12+ years experience or MS and 10+ years experience or Ph.D and 6+ years experience.
Principal Scientist: BS and 14+ years experience or MS and 12+ years experience or Ph.D and 10+ years experience.
The candidate should have capability, skill and/or knowledge in most of the following areas:
- Biopharmaceutical / combination drug product development
- Cell and gene therapy
- Regulatory guidance related to biologics, cell and gene therapy, aseptic processing, validation, cGMP, and combination products
- Knowledge of fill-finish unit operations such as filtration, mixing, and aseptic filling.
- QbD, experimental design, statistics, data analysis
- Leadership, communication ability, and ability to influence
- Technical writing and documentation
- Development of fill-finish, combination product assembly, cell or gene therapy, and/or associated manufacturing processes.
- Tech transfer experience or experience organizing and leading cross-functional teams is required.
- A high degree of self-motivation, scientific strength and technical rigor is required.
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.