Director of Formulation Development

Director/Sr. Director of Drug Product CMC

Greater San Diego 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 crossfunctional 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 (CDMOs) – highly coveted

Experience authoring CMC sections for IND, NDA & MAA is highly sought after