Associate Director Biologics Analytical Operations for a Leading and Global Biotech Organization
* Located in Greater San Diego Area
* Competitive Salary + Relocation Assistance + Benefits
The AD Biologics Analytical Operations will have the following Responsibilities:
* Lead the teams for late stage development programs and have oversight over risk management, strategic planning and timeline management.
* Collaborate with internal and external stakeholders to further develop the analytical development strategy
* Perform technical review for the analytical documents related to method development/validation, RS qualification, comparability studies, specifications, product characterization, CQA assessment, batch release and stability studies
* Author analytical related regulatory documents and assist with preparation for regulatory meeting.
* Support the outsourcing group for technical evaluations.
* Work closely with the cross functional groups to achieve the project goals.
The Ideal Candidate will have the following skill set:
* Ph.D. in Biological Sciences, Chemistry, Chemical engineering, Pharmaceutical Sciences, or relevant field
* 7+ years' experience in analytical development from early development to commercial launch
* Must have late stage development knowledge and BLA experience.
* Proven experience with managing CMO/CRO relationships and projects
