Scientist I, Upstream Process Development

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 manufacturing. Beyond process 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 through 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
• 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:

• Experience in ATF/TFF perfusion system, process intensification or continuous biomanufacturing
• 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
• Experience in writing and reviewing process-related documents
• Strong verbal and written communication and interpersonal skills
• Strong ability for people management