Development Scientist II, Analytical Development and Clinical QC at Alexion in New Haven, Connecticut

Job Description:

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 ESI-ToF, ESI-Orbitrap, and MALDI-ToF 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 cross-functional development teams representing the Protein Characterization group and lead scientific/technical problem-solving efforts.
- Author CMC sections for regulatory filings, technical reports, department-specific 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 problem-solving 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 problem-solving and non-linear 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 2-5 years related experience.
- In-depth knowledge of charge variant analysis.
- In-depth knowledge of additional non-MS 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 long-term meaningful career by working on leading-edge 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 life-changing medicines. Apply now!



Date Posted

17-Mar-2025



Closing Date

11-May-2025Alexion 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 accommodations@Alexion.com. Alexion participates in E-Verify.