Working with a global pharmaceutical company looking to enhance their CMC team, primarily within their late-stage portfolio. Their looking to bring on Scientists who have experience with Biologics and are looking to gain exposure with late-stage programs & will also have access to CGT programs.
Responsibilities
- Lead development team for late-stage formulation efforts for Biologics (different modalities)
- Interpret raw data, organize results, generate/review reports, and communicate findings to internal teams
- Will oversee tech-transfers, scale-ups, and outsourced formulations
- Help design effective CMC program strategy alongside internal functions
- Will primarily work on late-stage programs (including CGT)
Qualifications
- M.S. degree with ideally 8+ years of relevant experience is required, Ph.D. preferred
- Expertise in drug delivery systems, Bio-pharmaceutical dosage forms, and technology transfer through demonstrated experience
- Experience authoring CMC sections for IND, BLA & MAA is highly sought after
- Proven leadership and communication skills
- Late stage experience is highly sought after
