This is what you will do:
Scientist I is responsible for developing, characterizing and supporting technology transfer of robust drug substance manufacturing processes for biologics. The ideal candidate will have in-depth of knowledge of principles and theories of cell line development, medium and feed development, cell culture processes, or bioseparations including chromatography, filtration, and precipitation. The candidate is expected to perform detailed scientific research, execute experiments, analyze experimental data, and provide recommendations to improve efficiency of drug substance man u factu r ing. Beyond proces s development for pipeline molecules, the candidate will support the development of next generation biomanufacturing capabilities through process intensification and continuous manufacturing.
You will be responsible for:
- Develop and optimize robust and scalable drug substance manufacturing processes (upstream and downstream) for GMP manufacturing of biologics for clinical and commercial supply
- Lead evaluation of next generation manufacturing process throug h to improve the efficiency and cost effectiveness for current work flow
- Lead process scale up evaluation and support process tech transfer
- Lead small-scale model qualification and process characterization studies
- Author internal technical protocols and reports which may have strong interface with other technical functions, regulatory, and compliance
- Serve as subject matter expert for cell line/upstream/downstream processes across Alexion internal and external manufacturing network for clinical and commercial processes
You will need to have:
- Highly preferred: PhD (0 yrs industrial exp needed), or enrolled in PhD program with expected graduation within 3-4 months; MS (+ 6-10 yrs of industrial experience), or BS with at least 10 years of experience in biotechnology/pharmaceutical industry
- T echnical knowledge of cell line, upstream, or downstream process development for biologics
- S cientific principles and concepts in the field of process development
- T echnical proficiency, scientific creativity, learning agility, and ability to collaborate with others
- The ability to troubleshoot small and large scale equipment used in upstream/purification processes in area of expertise, and to offer solutions is expected
- Strong ability lead cross functional teams
- The duties of this role are generally conducted in a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/ degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
We would prefer for you to have:
- Experience in ATF/TFF perfusion system, process intensification or continuous bio manufacturing
- Experience in Process Analytical Technology (PAT) such as Raman
- Experience in molecular biology, medium and feed development , aseptic techniques and bioreactor operation
- Knowledge and use of statistical analysis, multivariate data analysis and DOE
- E xperience in writing and reviewing process-related documents
- Strong verbal and written communication and interpersonal skills
- Strong a bility for people management
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 authorization and employment eligibility verification requirements.
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