Director Downstream Process Development for a Leading and Global Biotech Organization
* Located in Greater Baltimore/DC area
* Competitive Salary + Relocation Assistance + Benefits
The Director Downstream Process Development will have the following Responsibilities:
* Work with Quality Assurance and Quality Control teams to ensure compliance with cGMP regulatory requirements.
* Oversee all Downstream Process Development activities as well as the downstream process development team.
* Author, review, and revise Batch Production Records
* Contribute to continual improvement of all manufacturing documentation
* Communicate operational status regularly to the CEO and the leadership team
The Ideal Candidate will have the following skill set:
* Ph.D. or Masters in a relevant field
* 10+ years Industry experience working in Downstream process development with 5+ being in a managerial role
* Strong background in virus and protein purification, ideally with Biologics, Cell & Gene Therapy or Virology
* Thorough understanding of GxPs, process characterization/validation, and tech transfers
