Development Scientist II Analytical Development Quality Control

Job Title: Development Scientist II Analytical Development and Clinical Quality Control

Introduction to role:

Are you ready to make a difference in the world of biotherapeutics As a Development Scientist II 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 be involved in nonGxP sample testing regulatory filings and responses to agencies. This position requires regular interaction with various functional areas including Research Biologic Drug Substance Development Injectable Drug Product Development Manufacturing Quality Assurance and Quality Control groups.

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 understanding the impact of decisions on these 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 in a crossfunctional environment

Assisting with prioritizing technical work efficiently to meet project timelines

Multitasking and achieving milestone deliverables across multiple projects

Exploring new cuttingedge technologies and automation to improve throughput and efficiency of bioassay and impurity methods

Establishing continuous improvement systems based on lessons learned and incorporating improvements into business practices

Positively contributing to improving the working environment and engaging in ongoing Alexion cultural improvement efforts

Essential Skills/Experience:

You will need to have:

Ph.D. degree with a minimum of 25 years of analytical method development and qualification experience in pharmaceutical or biotechnology setting with high preference in ELISA binding assay enzymatic assay cellbased assay and processderived impurity methods

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 a good understanding of biological pathways and biotherapeutics mechanism of actions

Ability to take initiative in problemsolving 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 oversee the generation of procedures protocols and reports pertaining to test methods

Ability to travel up to 10 to support onsite training and troubleshooting

Capability to work comfortably in a controlled lab environment with biological infectious and hazardous materials; lift/carry 15/30 pounds unassisted/assisted; gown/degown PPE; use a computer; engage in communications via phone video and electronic messaging; engage in problemsolving and nonlinear thought; collaborate with others; maintain general availability during standard business hours

Desirable Skills/Experience:

We would prefer for you to have:

Ph.D. degree with equivalent 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 you will join a team that is dedicated to making a difference in the lives of patients with rare diseases. Our innovative spirit drives us to continuously improve and create meaningful value. We offer an energizing culture where you can grow professionally while making a significant impact. Our commitment to diversity inclusion and patientcentricity ensures that your work here is both fulfilling and impactful.

Ready to join us on this exciting journey 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.