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 processderived 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 nonGxP 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 phaseappropriate qualification of bioassays to evaluate quantitative biological biochemical and cellular activities for therapeutic proteins

Phaseappropriate qualification for processderived 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 crossfunctional scientific/technical problemsolving efforts and conducting persuasive scientific/technical presentations

Assisting with prioritizing technical work efficiently to meet project timelines

Multitasking 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 02 years or master degree with a minimum of 58 years of analytical method development and qualification experience with high preference in ELISA binding assay enzymatic assay cellbased assay and processderived 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 onsite training and troubleshooting

The duties of this role are generally conducted in a lab environment. As is typical of a labbased 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 nonlinear 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 AstraZenecas 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 connectionconnecting 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!

Date Posted

28Mar2025

Closing Date

Alexion 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 EVerify.