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An established industry player is looking for a dynamic Director/Associate Director/Principal Scientist to spearhead innovative efforts in cancer biotherapeutics. This role offers the chance to lead analytical development for cutting-edge targeted therapeutics, making a significant impact on the lives of cancer patients. You will be part of a collaborative team, driving the development of novel therapies while overseeing regulatory strategies and mentoring a talented group of professionals. This is a unique opportunity to contribute to groundbreaking work in a supportive and competitive environment, where your expertise will shape the future of cancer treatment.
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 10+ 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.