Associate Scientist IV, Injectable Drug Product Development

The Associate Scientist IV will join the Injectable Drug Product Development group to support the formulation and drug product process development of Alexion's biotherapeutic candidates. This individual will be responsible for developing injectable formulations with fit-for-purpose analytical methods, performing analytical testing, and drafting reports for the executed studies. The role requires working independently in a dynamic team environment and routinely collaborating with other members of the Injectable Drug Product Development team as well as other groups in Product Development and Clinical Supply. Key responsibilities include the execution of formulation screening and stability studies for injectable drug products, which may include proteins, oligonucleotides, and peptides. The Associate Scientist IV will support analytical method development and optimization, as well as the development and tech transfer of GMP fill finish processes to both internal and external manufacturing organizations. Additionally, this role involves writing internal technical reports on the executed studies and assisting in the preparation of external regulatory submissions (IND, BLA, etc.) for Alexion's product candidates. Participation in department meetings and other technical and team-building activities is also expected. The ideal candidate will possess a BS or MS degree in Biochemistry, Chemistry, Chemical Engineering, or a related discipline from an accredited university, with a minimum of 6+ years of experience for MS or 7+ years of experience for BS. Extensive experience in developing phase-appropriate formulations and fill finish processes is essential, along with working experience on various injectable dosage forms in vials, prefilled syringes, or cartridges. A comprehensive understanding of chemistry, stability, and degradation mechanisms of proteins and peptides is required. The candidate should demonstrate the ability to work effectively in a collaborative setting and adhere to timelines, as well as possess firsthand 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) is also necessary, along with the ability to interpret raw data, organize results, and communicate findings to the project team and management.