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- Ensure protocols align with company policies, cGMP, and FDA regulations
- Experience from Discovery to Commercialization
- Interpret data, organize and communicate findings
- Oversee tech-transfers, scale-ups, and outsourced formulations
- Collaborate with crossfunctional CMC Depts, Regulatory, Quality, & Commercial
- M.S or Ph.D. in Pharmaceutical Sciences or related field with 10+ years of industry
- Experienced in formulation design, scale-up, tech transfers, & Quality by Design (QbD) studies
- Past experience with outsourced vendors - highly desired
- Experience in authoring CMC sections for IND, NDA & MAA is a plus
Director of Formulation Development - California, United States - EPM Scientific
Description
Director/Sr. Director of Drug Product CMC
Greater San Diego Area
Join an innovative Biopharma in the Greater San Diego Area
Partnered with an emerging Biopharma focusing on cutting-edge novel therapies with programs from Pre-IND to Commercialization. This Biopharma is looking to enhance its CMC leadership team with a scientific leader to spearhead Formulation, Drug Product, and Manufacturing Dept.
Responsibilities:
Requirements: