Associate Director Of Drug Product Cmc

Associate Director/Director - Formulations(Drug Product)

Greater Boston Area

Hybrid Model Available

Partnered with an industry leading Biotech focusing on several cutting-edge novel therapies for Biologics. This organization is seeking to enhance it's CMC executive team with the addition of a scientific leader within 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

• Lead Biologics Pipeline(Preclinical - Phase III)

Qualifications

• M.S or Ph.D. in Pharmaceutical Sciences or a related scientific field with ideally 7+ 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, BLA & MAA is highly sought after