Development Scientist I, Analytical Development and Clinical Quality Control

Introduction to role

Are you passionate about advancing biotherapeutic products? As a Development Scientist I, you will be at the forefront of developing, qualifying, and optimizing 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 play a critical role in non-GxP sample testing, regulatory filings, and responding to agencies. This position involves regular interaction with various functional areas, including Research, Biologic Drug Substance Development, Injectable Drug Product Development, Manufacturing, Quality Assurance, and Quality Control groups.

Accountabilities

• Develop, optimize, and qualify bioassays to evaluate quantitative biological, biochemical, and cellular activities for therapeutic proteins.
• Responsible for phase-appropriate qualification for process-derived impurity methods and impurity work strategy to support process development, product release specification, and regulatory filing.
• Make scientific/technical proposals of strategic nature based on corporate or project objectives.
• Author SOPs, study plans, protocols, method development/qualification reports, and draft corresponding IND and BLA sections for regulatory filing.
• Lead cross-functional scientific/technical problem-solving efforts and present scientific/technical information persuasively.
• Assist with prioritizing technical work efficiently to meet project timelines.
• Multi-task and achieve milestone deliverables across multiple projects.
• Explore new innovative technologies and automation to improve throughput and efficiency of bioassay and impurity methods.
• Establish continuous improvement systems based on lessons learned.
• Positively contribute to improving the working environment and engage in ongoing cultural improvement efforts.
  
  
  

Essential Skills/Experience

• A minimum of 0-2 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.
• Experience with method development, optimization, qualification, validation, transfer, and investigation for biotherapeutics.
• Familiar 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 a good understanding of biological pathways and biotherapeutics’ mechanisms of action.
• Ability to take initiative in problem-solving and consistently bring an 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.
• Ability to independently contribute to and lead all aspects of the generation of procedures, protocols, and reports pertaining to test methods.
• Ability to travel up to 10% to support on-site training and troubleshooting.
  
  
  

Desirable Skills/Experience

• Ph.D. or Master’s degree with equivalent level of experience in Biochemistry, Molecular and Cellular Biology, Immunology, Chemistry, Bioengineering or related field.
• 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).
  
  
  

When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of four days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca's Alexion division, we are driven by a pioneering spirit that fuels our innovation in rare diseases. Our commitment to patients brings us closer to our work and each other. With a rapidly expanding portfolio and an entrepreneurial culture, you'll find opportunities to grow and make a meaningful impact every day. We value diversity, inclusiveness, and integrity as we strive to change lives for the better.

Ready to make a difference? Apply now!