A leading Pharmaceutical organization is looking to enhance its Research and Development team with the addition of an Associate Director/Team Lead of Formulation(Biologics).
- Formulation/ Drug Product & Manufacturing
- Greater San Diego Area
Duties and Responsibilities
- Ensure protocols follow the company policies, cGMP and FDA regulations
- Strong communication, organization, and multitasking skills are needed to lead
- Interpret raw data, organize results, generate/review reports, and communicate findings to project teams and management
- Will oversee tech-transfers, scale-ups and outsourced formulation/process development
- Will overlook the Biologics Late Stage portfolio
- Strong hands-on experience within biologics formulations
- Past experience with parenterals/ Injectables is heavily sought after
- Experienced in formulation design, scale-up, tech transfers, & Quality by Design (QbD) studies.
- Past experience overseeing outsourced vendors (CROs/CMOs/CTLs/CDMOs) - highly coveted
- M.S or Ph.D. in Pharmaceutical Sciences or a related scientific field with ideally 5-7 years of industry
- Experience authoring CMC sections for IND, BLA, and NDA is highly sought after