Associate Director of Formulation & Pharmaceutical Development
Greater San Francisco Area
Competitive Compensation + excellent bonus/benefits
Partnered with an industry leading Biotech focusing on several cutting-edge novel therapies. This organization is seeking to enhance its CMC executive team with the addition of a scientific leader to spearhead their Formulation and Pharmaceutical Development group.
Duties and Responsibilities:
- Experienced in formulation and process development, manufacture and scale-up of parenteral drug products. Expertise in parenteral drug delivery technologies
- Provide scientific, technical and hands-on support of drug discovery and product development
- Ensure protocols follow the company policies, cGMP and FDA regulations
- Present results of work, interprets data, generate/review reports, communicate findings to project teams and management
- Will oversee tech-transfers, scale-ups, and outsourced formulations
- Experience with lab work related to small molecules
Qualifications:
- Strong hands-on experience in Drug Product/Formulations
- Experienced in formulation design, scale-up, tech transfers, & Quality by Design (QbD) studies.
- Experience overseeing outsourced vendors (CROs/CMOs/CTLs/CDMOs) - highly coveted
- Ph.D. in Pharmaceutical Sciences or a related scientific field with ideally 3+ years of industry experience
- Experience authoring CMC sections for IND, BLA/MAA is highly sought after
- Remote Option Available