Careers
ArriVent Biopharma is looking for a highly motivated, entrepreneurial individual to support formulation, drug product development, and technology transfer to CDMOs to advance ArriVent’s portfolio. This is a remote role.
Key Responsibilities
- Serve as the subject matter expert for formulation development, characterizing and optimizing drug product manufacturing processes.
- Lead technical transfer, scale up, clinical and commercial manufacturing at CDMOs, including support person-in-plant. Review development plan/reports, tech transfer documents and batch records. Solve problems when development or manufacturing issues arise at CDMOs.
- Write high quality technical protocols and reports to describe formulation and process development activities.
- Authoring CMC sections to support regulatory submissions (NDA/MAA/IND/IMPD). Prepare meeting documents with health authorities. Respond to agency questions.
- Support commercial drug product packaging development and manufacturing. Supervising and managing Contract Packaging Organizations (CPOs).
Desired Skills and Experience
- Recent experience in authoring successful NDA submission for small molecule oral solid dosage form is key. Familiar with FDA and EMEA requirements is a plus.
- Knowledge about small molecule formulation development is required. Characterization of unit operations by performing risk assessments and establishing operational design spaces for scale-up.
- Ability to analyze and interpret problems and provide solutions.
- Experience in leading small molecule drug product tech transfer of clinical and commercial products to CDMOs.
- Knowledge and experience in designing and developing commercial drug product packaging is a plus.
- A rational approach to problem solving, scientific curiosity, strong analytical skills.
- Strong collaboration and communication skills, and ability to influence others.
Education Requirement
- D. in Pharmaceutical Sciences, Chemical Engineering or related filed with 2-5 years of relevant industrial experience OR
- Sc./M.Sc. with relevant industrial experience to an equivalent level