Development Scientist II, 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 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

• A minimum of 2-3 years of analytical method development and qualification experience in pharmaceutical or biotechnology setting
• 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 good understanding of biological pathways and biotherapeutics’ mechanism of actions
• Ability to take initiative 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 lead 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 conducted in a lab environment. 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

Desirable Skills/Experience

• Ph.D. or MS 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
• Has 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)
• ELISA binding assay, enzymatic assay, cell-based assay, and process-derived impurity methods

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!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.