Associate Scientist IV, Injectable Drug Product Development at Alexion

This is what you will do:The Associate Scientist IV will join Injectable Drug Product Development group to support the formulation and drug product process development of Alexions biotherapeutic candidates. This individual will develop injectable formulations with fit for purpose analytical methods perform analytical testing and draft reports for the executed studies. This individual will work independently in a dynamic team environment and routinely collaborate with other members of Injectable Drug Product Development as well as other groups in Product Development and Clinical Supply.You will be responsible for:Execution of formulation screening and stability studies for injectable drug products including proteins oligonucleotides and peptidesBuilding expertise in in-use and extractables and leachables assessmentsSupporting analytical method development and optimizationSupporting development and tech transfer of GMP fill finish processes to internal and external manufacturing organizationsWriting internal technical reports on the executed studiesAssisting in preparation of external regulatory submissions (IND BLA etc.) for the Alexion product candidatesParticipate in department meetings and other technical and team building activitiesYou will need to have:Extensive experience in in-use and E&L assessment across different phases of developmentExtensive experience on developing phase appropriate formulations and fill finish processesWorking experience on various injectable dosage forms in vials prefilled syringes/ cartridgesComprehensive understanding of chemistry and stability and degradation mechanism of proteins and peptidesExcellent interpersonal and communication skills and ability to work in a collaborative setting and adhere to timelinesDemonstrated ability to work effectively in a cross-functional settings.Hands-on experience with liquid chromatography methods (e.g. SEC IEX HIC) and capillary methods (e.g. iCE LabChip GXII Touch)Strong knowledge of analytical software (e.g. Empower JMP)Ability to interpret raw data organize results and communicate findings to project team and managementUnderstanding of the biotechnology products life cycle and factors impacting product stability.The duties of this role are generally conducted in an 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/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.We would prefer for you to have:BS or MS degree in Biochemistry Chemistry Chemical Engineering or related discipline from an accredited university with with 6 years of experience for MS or 7 years of experience with BS.Knowledge of cGMP and quality guidelines.Date Posted03-Dec-2025Closing Date23-Dec-2025Our 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.Required Experience:IC Key Skills Fire Protection,Attorney At Law,Cost Estimation,Cloud Services,Art & Design Employment Type : Full-Time Experience: years Vacancy: 1