Associate Director Drug Product Development for a Global Pharma company
* Based in Greater RTP North Carolina,
* Competitive compensation package
The Associate Director Drug Product will have the following Responsibilities:
* Work cross functionally with R&D senior staff to craft technical strategy for development of new drug products and maintain lifecycle management for current product lines.
* Provides technical subject matter expertise in the drug product development space including formulation development, lyophilization, and delivery device design and selection for biologics
* Oversees drug product development projects starting at early development stage gates including technical transfer from Research, formulation development, device design and development, and non-clinical and early phase clinical production
* Author necessary documents; including product and process development plans, contract development and manufacturing proposals, quality target product profiles (QTPP), and technical transfer plans
* Provides technical oversight of product and process development activities sub-contracted to 3rd party development and manufacturing organizations
The Ideal Candidate will have the following skill set:
* Degree in a Relevant Field with accompanying industry experience, 8+ years with PhD
* Technical Expertise in all Drug Product Development activities for the selection of Biologics
* Experienced writer/reviewer of necessary technical documentation
* Strong leadership experience and history of success.
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