Development Scientist I, Analytical Development & Quality Control

Job Title: Development Scientist I, Analytical Development and Clinical Quality Control

Introduction to role:

Are you ready to make a significant impact in the world of biotherapeutics? As a Development Scientist I, you will play a crucial role in the development, qualification, and optimization of bioassays and process-derived impurity methods. Your work will support the release and stability testing of biotherapeutic products, as well as formulation and process development. You will also engage in non-GxP sample testing, regulatory filings, and responses to agencies. This position involves collaboration with various functional areas, including Research, Biologic Drug Substance Development, Injectable Drug Product Development, Manufacturing, Quality Assurance, and Quality Control.

Accountabilities:

You will be responsible for:

• Development, optimization, and phase-appropriate qualification of bioassays to evaluate quantitative biological, biochemical, and cellular activities for therapeutic proteins
• Phase-appropriate qualification for process-derived impurity methods and impurity work strategy to support process development, product release specification, and regulatory filing
• Making scientific/technical proposals of strategic nature based on corporate or project objectives
• Authoring SOPs, study plans, protocols, method development/qualification reports, and drafting corresponding IND and BLA sections for regulatory filing
• Leading cross-functional scientific/technical problem-solving efforts and conducting persuasive scientific/technical presentations
• Assisting with prioritizing technical work efficiently to meet project timelines
• Multi-tasking and achieving milestone deliverables across multiple projects
• Exploring new innovative technologies and automation to improve throughput and efficiency of bioassay and impurity methods
• Establishing continuous improvement systems based on lessons learned
• Positively contributing to improving the working environment and engaging in ongoing cultural improvement efforts
  
  
  

Essential Skills/Experience:

You will need to have:

• Ph.D. degree with a minimum of 0-2 years, or master degree with a minimum of 5-8 years of analytical method development and qualification experience with high preference in ELISA binding assay, enzymatic assay, cell-based assay, and process-derived impurity methods. Or
• Experience with method development, optimization, qualification, validation, transfer, and investigation for biotherapeutics
• Familiarity with cGMP, ICH, USP and WHO guidelines on regulatory requirements for analytical method development, qualification, and validation
• Strong scientific skills in biochemistry, molecular and cellular biology with good understanding of biological pathways and biotherapeutics’ mechanism of actions
• Ability to take initiative in problem solving and consistently bring independent, scientific approach to method development
• Excellent interpersonal skills and a strong ability to communicate effectively
• High level of proficiency in MS Office software including Word, Excel, Outlook, Visio, PowerPoint, and Softmax Pro
• The ability to independently contribute and oversee the generation of procedures, protocol and reports pertaining to test methods
• Ability to travel up to 10% to support on-site training and troubleshooting
• 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/de-gown 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
  
  
  

Desirable Skills/Experience

We would prefer for you to have:

• Ph.D. or Master degree with required level of experience in Biochemistry, Molecular and Cellular Biology, Immunology, Chemistry, Bioengineering or related discipline
• Technical lead and/or people managing skills highly preferred
• Knowledge of other technical areas within ADQC/PDCS organization (Other analytical methods such as LC, CE and compendial methods within ADQC; process development and formulation development within PDCS)
  
  
  

At AstraZeneca's Alexion division, we are driven by our passion for making a difference in the lives of patients with rare diseases. Our culture is built on diversity, inclusion, and the relentless pursuit of innovation. We believe in the power of connection—connecting with our patients' journeys and connecting with each other to foster new ideas. Here, you will find an environment that values your contributions and supports your growth through tailored development programs. Join us in our mission to change lives every day.

Ready to make an impact? Apply now!