Director/Associate Director, Drug Product (Biologics) - Multiple Openings
Greater DMV Area
REMOTE OPTION AVAILABLE
Summary
Partnered with an industry leading Biotech focusing on several cutting-edge novel therapies. This organization is seeking to enhance it's CMC executive 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
- Lead Biologics Pipeline(Preclinical - Phase III & Commercialization)
- Exposure to different modalities such as mAbs, ADC's, LNP/mRNA, Fusion Proteins, etc.
Qualifications
- Strong hands-on experience in Drug Product/Formulations
- 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 7+ years of industry
- Experience authoring CMC sections for IND, BLA/MAA is highly sought after
- Remote Option Available
