Scientist I, Upstream Process Development
Alexion

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
  
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• 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:

• 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:

• 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
  

Date Posted
29-Mar-2024

Closing Date
31-May-2024Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

This job has expired.