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Job Description

Job Title Manager, CMC Technical Writer
Requirement ID 43283
Begin Date 10/19/09
Duration
Location Bothell,  WA 98021
Other Location
Description

Seattle Genetics is looking for a Manager, Process Sciences Regulatory Submissions to provide leadership within Process Sciences for the management and execution of all CMC related regulatory submissions. This person will serve as the Process Science regulatory CMC representative on relevant project teams. The position will report to the EVP of Process Sciences.

 
Duties and Responsibilities:
 
  • Assist in drafting, reviewing and finalizing all CMC related submissions. This includes working with technical data and references and rough draft from technical lead authors and honing these documents into a final product.
  • Organize the resources, timelines, and project reporting dashboards necessary to keep management informed of document preparation progress.
  • Work with the AD Regulatory Affairs CMC and with colleagues in Process Sciences and Technical Operations to develop a global CMC regulatory strategy for our products
  • Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines.
  • Review and assess global regulatory impact of CMC changes relating to regulatory filings.

 
Required Skills - 4-year degree in Chemistry, Biochemistry, Molecular Biology, Biology or related field; advanced degree desirable.
- 5+ years experience in Process Sciences, Technical Operations or related departments working on the development of therapeutic biologics.
- Solid working knowledge of therapeutic biologics development process and knowledge of FDA and EU regulatory requirements;
- Previous experience in leading CMC submissions for clinical trial and/or marketing applications.
- Excellent organizational, communication and time management skills needed to manage multiple ongoing projects.