Development Scientist II Analytical Development and Clinical QC

Job Title: Development Scientist II Analytical Development and Clinical QC

Introduction to role

Are you ready to lead and perform mass spectrometry characterization of biotherapeutics from discovery to marketed products We are looking for a candidate with a proven track record in characterizing antibodies proteins and peptides by mass spectrometry. This includes intact molecular weight analysis subunit analysis peptide mapping modification identification disulfide bonding analysis glycan analysis sequence variant analysis and other analytical methodologies using HPLC/UPLC ESIToF ESIOrbitrap and MALDIToF instrumentation. If you have excellent team organizational writing and presentation skills and can interact regularly with scientific staff across various groups this role is for you!

Accountabilities

Lead and perform protein characterization (method development and analysis) by LC/MS.
Oversee and train associates to perform method development and analysis by LC/MS.
Participate in crossfunctional development teams representing the Protein Characterization group and lead scientific/technical problemsolving efforts.
Author CMC sections for regulatory filings technical reports departmentspecific protocols and general operating procedures.
Lead the development and authoring of new procedures and work practices.
Evaluate new technologies and independently develop protein characterization strategies.
Manage the activities of external research laboratories.

Essential Skills/Experience

Deep understanding and extensive direct experience with protein characterization by LC/MS using multiple mass spectrometry instruments and platforms.
Ability to lead problemsolving activities and bring independent scientific approaches to method development.
A thorough understanding of GLP and quality guidelines; ability to lead process improvements.
Ability to give clear instructions train and oversee personnel as required on practices within the laboratory.
Planning and organizing skills to plan execute and track commitments of the laboratory and adjust to changing priorities.
Understanding of the big picture for projects and tasks involved prioritizing work of self and others accordingly.
Ability to work comfortably in a controlled 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 analysis and dialogue; collaborate with others; maintain general availability during standard business hours.

Desirable Skills/Experience

PhD in Biochemistry Chemistry or related discipline with a minimum of 25 years related experience.
Indepth knowledge of charge variant analysis.
Indepth knowledge of additional nonMS methods and instrumentation for testing biotherapeutics.
Experience with development optimization qualification and validation of biotherapeutic assays.
Experience working with CROs for developing assays and testing samples.

At AstraZeneca we embrace new opportunities to develop and learn. Our environment is built on lifelong learning where we seek to expand our knowledge continuously. Here you can build a longterm meaningful career by working on leadingedge projects or varied stages and molecules. We are committed to making a difference by fusing data and technology with the latest scientific innovations to achieve breakthroughs. Our inclusive environment encourages collaboration with academia biotechs and the industry to create the greatest impact on disease.

Join us in pushing the boundaries of science to deliver lifechanging medicines. Apply now!

Date Posted

10Apr2025

Closing Date

25May2025Alexion 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.