Development Scientist I, Analytical Development and Quality Control

This role focuses on the analytical characterization of biotherapeutics from clinical through commercial stages with a strong emphasis on antibodies proteins and peptides. The work involves applying a range of analytical techniques for size and charge variant analysis and interpreting protein post-translational modifications and their impact on biological function. A key expectation is the ability to independently design and generate procedures protocols and reports for protein forced degradation studies fractionation studies comparability assessments and critical quality attribute (CQA) evaluations. Additional responsibilities may include representing the group on cross-functional development teams as well as training and leading elected day-to-day activities of junior scientists. Ready to see how deep scientific rigor can directly influence patient outcomes

Accountabilities

In this position the Development Scientist I will perform enrichment fractionation and detailed characterization of protein variants including charge and size variants to support biotherapeutic development. The role includes designing and conducting experimental studies developing and optimizing analytical methods and delivering comparability and forced degradation studies that inform product understanding and control strategies. The scientist will summarize structurefunction relationship findings and author CQA reports that guide decision-making across development stages. Responsibilities extend to active participation in cross-functional development teams representing the Protein Characterization group and leading scientific and technical problem-solving efforts within the team. The role also includes authoring CMC sections for regulatory submissions technical reports department-specific protocols and reports and general operating procedures while driving the development and implementation of new procedures and work practices that improve analytical capabilities. How will your insights shape the next generation of rare disease therapies

Essential Skills/Experience

• BS degree with 8 years MS degree with 6 years or Ph.D. degree with 0 to 2 years in Chemist Biochemistry or related field of Industry experience
• Experienced in separations science (e.g. SEC RP IEX HIC CE-SDS and cIEF).
• experienced in protein size and charge variants identification and product quality attribute severity assessment.
• Planning and organizing skills to plan implement and track commitments of the laboratory and to adjust to changing priorities.
• High emotional intelligence excellent people skills and effective communication skills.

Desirable Skills/Experience

• Experience in characterization of various biologic modalities (e.g. mAb multi-specifics fusion protein enzyme).
• Experience in CMC development activities including analytical DS upstream and downstream formulation and DP activities.

When we put unexpected teams in the same room we ignite ambitious thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of four days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility.

Join us in our outstanding and ambitious world!

At AstraZenecas Rare Disease unit scientific expertise meets a clear purpose: translating complex biology into transformative medicines for people living with rare and devastating conditions. Work here means engaging closely with patients real experiences collaborating with talented colleagues across disciplines and contributing to a rapidly evolving portfolio that pushes the boundaries of biopharmaceutical science. The environment combines the agility of a biotech with the reach and resources of a global organization offering room to grow skills explore new ideas and see the impact of rigorous analytical science on therapies that address profound unmet needs.

If this opportunity resonates and you are ready to help shape the future of rare disease therapies through analytical excellence please apply now!

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and furtherance of that mission we welcome and consider applications from all qualified candidates regardless of their protected characteristics. If you have a disability or special need that requires accommodation please complete the corresponding section in the application form.