Director/Associate Director of Drug Product CMC
Hybrid Model Available
Greater NYC Area
Partnered with an emerging Biopharma focusing on several cutting-edge novel therapies with several programs ranging from Pre-IND to Commercialization. This Biopharma is seeking to enhance it's CMC leadership team with the addition of a scientific leader to spearhead their Formulation, Drug Product, and Manufacturing Dept.
Duties and Responsibilities
- Ensure protocols follow the company policies, cGMP and FDA regulations
- Extensive experience from Discovery, Pre-formulation, Formulation to Commercialization
- Interpret raw data, organize results, generate/review reports, and communicate findings to project teams and management
- Will oversee tech-transfers, scale-ups, and outsourced formulations
- Closely collaborate with cross-functional CMC Depts, Regulatory, Quality, & Commercial
Qualifications
- M.S or Ph.D. in Pharmaceutical Sciences or a related scientific field with ideally 10+ years of industry
- Experienced in formulation design, scale-up, tech transfers, & Quality by Design (QbD) studies.
- Past experience overseeing outsourced vendors (CROs/CMOs/CTLs/CDMOs) - highly coveted
- Experience authoring CMC sections for IND, NDA & MAA is highly sought after
