What are the responsibilities and job description for the Director/Associate Director/Principal Scientist, Analytical Development position at Initial Therapeutics, Inc.?
We seek a highly talented and motivated Director / Associate Director / Principal Scientist to drive Adcentrx Therapeutics' ground-breaking efforts in cancer biotherapeutics drug development. The candidate will join a new development team in San Diego, with the goal of developing novel targeted therapeutics that can make a difference in the life of cancer patients.
The Director / Associate Director / Principal Scientist will report to the VP of CMC and will work closely with members of the development and research team. The candidate will be part of a cross-functional team in a highly collaborative and dynamic environment working closely on a shared mission.
Responsibilities :
The candidate will be responsible for leading the analytical development efforts to support late-stage clinical bioconjugate development. They will be responsible for analytical development and qualification activities including setting project priorities, coordinating CMO activities, and developing regulatory strategies. The ideal candidate will have experience with late-stage analytical development, building and mentoring a team, as well as writing / reviewing regulatory documents.
Qualifications :
- PhD in chemistry, analytical chemistry or other relevant disciplines with more than ten years experience in industry setting
- Proven track record of leadership and team management
- Hands-on experience developing analytical methods to characterize biologics and / or bioconjugates
- Experience overseeing analytical development of late-stage assets
- Knowledge of statistics as it relates to analytical development
- In-depth knowledge of analytical-related FDA regulations and guidelines as well as experience reviewing and approving analytical-related CMC sections of IND and BLA regulatory submissions. Knowledgeable in European, Chinese and US CMC regulatory requirements for biologics
- Experience with method qualification, validation, and method transfer
- Strong organizational and communication skills
Adcentrx Therapeutics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the lives of our employees and their families. Benefits include medical, vision and dental coverage, 401(k), paid time off, and stock options.
Adcentrx Therapeutics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.
To learn more, visit us at http : / / www.adcentrx.com
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