Associate Scientist II, Injectables Drug Product Development | New Haven, CT

including biophysical characterization and formulation development of a wide range of protein drug modalities. A general understanding of protein chemistry and/or the ability to run biomedical assays in a laboratory is preferred. Experience with electronic record keeping and data software, like electronic lab notebooks, End Note, maintenance of laboratory instrumentation (organizing preventative maintenance, data backup, software upgrade, etc.

), as well as MS Word, Power Point, Excel/Graph Pad, Visio, and Adobe Pro, would be an advantage. Responsibilities With some supervision, design and execute development studies for Alexion medicals' clinical drug candidates and commercial products,

characterizing protein drug conformational and colloidal stability using industry standard methodology (e. g. circular dichroism, differential scanning fluorimetry, analytical ultracentrifugation, size-exclusion chromatography, etc.

) Previous experience using in-silico modeling software (e. g. MOE) is desirable. Can prioritize multiple assigned tasks and projects. The ability to work independently as well as part of the team is essential. Perform data analysis as well as author technical reports and or relevant sections of clinical and commercial regulatory filings on the executed studies for the Alexion drug product candidates Become current with the literature about drug product manufacturing

processes, manufacturing equipment and single use systems as well as associated global regulatory expectations Actively participate in department and team meetings including assuming ownership and delivering on assign action items.

Develop presentations for meetings with internal and external stakeholders with some supervision. Requirements BS in Chemistry, Biochemistry, Chemical Engineering, medical Sciences or relevant Engineering/Life Sciences field with 2+ years of experience or MS degree with 1+ years is required Scientific and practical knowledge of protein biochemistry and/or drug product process development is preferred. Previous experience in biotherapeutics development as well as a general knowledge of c GMP and Quality expectations is preferred.

Understanding of the biotherapeutics drug formulation development and analytical tools used to test formulations is a plus. Ability to take initiative in problem solving and finding solutions to scientific challenges is preferred. The individual must be able to work in a collaborative setting and ability to adhere to timelines is essential. Excellent interpersonal skills are required, as is the strong ability to communicate effectively. The duties of this role are generally conducted in a lab environment.

As is typical of a lab-based 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/de-gown PPE; use a computer; engage in communications via phone, video, and electronic messaging Date Posted 21-Jul-2023 Closing Date 29-Dec-2023Alexion 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, interaction, interactionual 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.

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