Formulation & Process Development
A top ten biopharmaceutical company looking for an Associate Director in Formulation & Process Development to join their team and help make a change to the world. This would be a great fit for anyone that focuses on pharmaceutical development.
Duties and Responsibilities:
- Able to facilitate, analyze and interpret the data from experiment results
- Ensure protocols are in compliance with company policies, such as cGMP, USP and FDA regulations
- Author, review and strategically impact CMC sections (IND and NDA submissions)
- Experience in drug product, technology transfer, formulation and process characterization, and stability testing
- Will work and manage in-house and external lab activities.
- Lead and overlook small molecule programs.
- Focus on multiple compounds within their pipeline (Preclinical & Clinical Phases I-III)
- Experience working amongst CMC leaders such as Regulatory, Analytical, Quality, Manufacturing
- Past experience overseeing outsourced vendors (CROs/CDMOs)
- Experience overlooking multiple drug candidates within the company's pipelines
- S or Ph.D. in Pharmaceutical Sciences or a related scientific field with ideally 5-7 years of industry experience
- Experience authoring CMC sections for IND, IMPD and NDA is highly sought after