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 a lead team, perform detailed scientific research, execute experiments, analyze experimental data, and provide recommendations to improve efficiency of drug substance manfuactuing. The Scientist I will lead and supportdevelopment studies for biologics lifecycle management and yield improvement with use of process intensification.
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 process scale up evaluation and support process tech transfer to clinical and commercial manufacturing sites including C(D)MO
Lead external projects to evaluate and implement new platform or technology to improve the efficiency for current work flow
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
Perform evaluation and due diligence for in-licensing, out-sourcing or collaboration opportunities.
Author and review regulatory submission such as IND/BLA and response to questions from health authority.
Develop and manage a group of associate scientists through direct supervision or as matrix leader to support professional development. Lead functional/cross-functional project team..
You will need to have:
A PhD in Biology/Chemistry/Chemical Engineering/Biological Sciences or related fields, MS with at least 8 years of experience, or BS with at least 10 years of experience in biotechnology/pharmaceutical industry
Technical knowledge of cell line, upstream, or downstream process development for biologics
Scientific principles and concepts in the field of process development
Technical 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:
Working knowledge of regulatory guidelines related to cell line, upstream, or downstream development and process characterization including viral clearance and process validation
Experience in microbial strain engineering and fermentation process development, medium and feed development, aseptic techniques and bioreactor operation
Experience using AKTA systems and unicorn software for purification development
Knowledge and use of statistical analysis, multivariate data analysis and DOE
Experience in writing and reviewing process-related documents
Experience in manufacturing and regulatory support
Strong verbal and written communication and interpersonal skills
Strong ability 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.
