Gene Vector Senior Scientist II Full-time NEW

Job Title

Responsible for the screening, development, and optimization of formulations for Lentiviral Vector.

Responsible for designing and executing pharmaceutical formulation studies, including formulation screening and development, drug product process development, process characterization, primary packaging component selection and compatibility studies, and stability studies.

Responsible for authoring formulation development protocols and reports, and compiling supporting technical documentation for regulatory submissions.

Consolidate and present formulation development data and project learnings; establish development workflows; and build formulation process development capabilities within the team.

Partner with upstream and downstream process development, QC, and manufacturing teams to enable technology transfer and manufacturing scale-up.

Master's degree or higher in Pharmaceutics, Pharmacy, Bioengineering, Biopharmaceuticals, Cell Biology, or a related field.

5+ years of experience in biologics formulation and process development; experience in LVV and AAV formulation development is preferred.

End-to-end experience in at least one relevant project covering formulation development, IND submission, and clinical supply manufacturing, together with demonstrated experience in preparing and compiling IND/NDA submission dossiers.

Strong knowledge of domestic and international regulatory requirements and formulation development guidelines, with demonstrated ability to independently lead project formulation activities and author IND/NDA submission dossiers.

Proficiency with DoE/statistical tools for study design and multivariate analysis (e.g., JMP, Design-Expert, Minitab).

Good command of written and spoken English, with the ability to search for and interpret international literature.

Strong teamwork and communication skills.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.