What are the responsibilities and job description for the Development Scientist II, Analytical Development and Clinical Quality Control position at Alexion Pharmaceuticals?
Introduction to role
Are you ready to make a significant impact in the world of biotherapeutics? As a Development Scientist II, you will be at the forefront of developing, qualifying, and optimizing bioassays and impurity methods to support the release and stability testing of biotherapeutic products. Your role will also encompass non-GxP sample testing, regulatory filings, and responses to agencies. You will collaborate with various functional areas, including Research, Biologic Drug Substance Development, Injectable Drug Product Development, Manufacturing, Quality Assurance, and Quality Control groups. This is your chance to contribute to groundbreaking advancements in the pharmaceutical industry!
Accountabilities
- Development, optimization, and phase-appropriate qualification of 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
- Makes scientific / technical proposals of strategic nature based on corporate or project objectives, and understands the impact of their decisions on corporate / project objectives
- Authors SOPs, study plans, protocols, method development / qualification reports. Drafts corresponding IND and BLA sections for regulatory filing
- Leads cross-functional scientific / technical problem-solving efforts. Carries out authentic, persuasive scientific / technical presentations of strategic nature in cross-functional environment
- Assists with prioritizing technical work efficiently to meet project timelines
- Ability to multi-task and achieve milestone deliverables across multiple projects
- Explores new innovative technologies and automation to improve throughput and efficiency of bioassay and impurity methods
- Establishes continuous improvement systems based on lessons learned, and incorporates improvements into ways of doing business
- Positively contributes to improving the working environment, and engaged in ongoing Alexion cultural improvement efforts
Essential Skills / Experience
Desirable Skills / Experience
When we put unexpected teams in the same room, we unleash 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, you will find an environment that fosters innovation and growth. Our entrepreneurial spirit combined with the resources of a global pharma company ensures that you can define your career path while making a real difference. We are committed to protecting our patients, our people, and our planet. Here you will be encouraged to take ownership of your work, develop new skills, and expand your capabilities.
Ready to make a difference? Apply now!
Date Posted
22-Jan-2025
Closing Date
29-Apr-2025Alexion 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 Alexion participates in E-Verify.
