SUMMARY
Our CMC team just partnered with an emerging Pharma Company focusing on several cutting-edge novel therapeutic areas with several programs in their pipeline. This organization 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 to advance their programs in various stages from IND to Commercialization.
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
- Ph.D. in Pharmaceutical Sciences or a related scientific field with ideally 10+ years of industry experience
- Must have a strong background in drug product development of sterile injectables, solid oral, & liquid dosage forms.
- Experienced in formulation design, scale-up, tech transfers, & Quality by Design (QbD) studies.
- Strong leadership experiece with leading teams
- Past experience overseeing outsourced vendors (CDMOs) - highly coveted
- Experience authoring CMC sections for IND, IMPD, NDA & MAA is highly sought after
