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Senior Scientist, Chemical Development
Job Description
Description
The successful candidate will be responsible for developing novel synthetic routes and chemical processes for anti-cancer drugs and proprietary drug linkers used for antibody conjugation. The ideal candidate should possess an in-depth knowledge of organic chemistry, reaction mechanisms, and should have experience in pharmaceutical process chemistry. Experience and expertise in peptide synthesis is desirable. Particular experience in executing chemical processes within GMP compliant facilities would be preferable.
Responsibilities:
• Serve as process chemistry project leader for development programs and participate as key member on cross-functional CMC development teams.
• Synthetic route selection and process optimization for drug linkers and active pharmaceutical agents.
• Provide scientific leadership in the advancement of ADC development candidates
• Provide technical recommendations based upon in-depth analyses of experimental results and commercial process performance data.
• Provide oversight for the transfer of chemical processes to third party manufactures, and develop novel and creative solutions to processing problems.
• Prepare technical documents and presentations in support of CMC activities and regulatory submissions.
• Define optimal methods for in-process monitoring and collaborate with analytical chemists to identify structure and origin of process impurities.
• Employ new principles and concepts from other fields to promote progress in organic synthesis and process chemistry within the ADC field.
• Articulate issues and options for resolution to upper management in a timely manner.
• Publish and present research internally and externally to Seattle Genetics
Requirements:
• PhD in synthetic organic chemistry
• Minimum of 5 years industrial experience in developing synthetic routes and chemical processes for active pharmaceutical ingredients.
• Knowledge of ICH/FDA regulations and GMP work practices for API manufacturing.
• Excellent written and oral communication skills; enthusiasm, integrity, self motivation, and ability to interact within a multi-disciplinary team.
• Prior project leadership experience in oncology / high potency APIs is preferable.
Seattle Genetics is an equal opportunity employer.
Company
Seattle Genetics, Inc.
Job Code
State or Province
Washington
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