What are the responsibilities and job description for the Associate Director/Principal Scientist/Senior Scientist, Process Development position at Adcentrx Therapeutics Inc.?
We seek a highly talented and motivated Associate Director / Principal Scientist / Senior 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 Associate Director / Principal Scientist / Senior Scientist will report to the VP of CMC and will work closely with members of the development and research teams. The candidate will be part of a cross-functional team in a highly collaborative and dynamic environment working closely on a shared mission. The candidate has the opportunity to be mentored and grow over time into a recognized leader in bio-oncology drug development.
Responsibilities :
The candidate will be responsible for developing processes for the manufacture of biologic, small molecule, and conjugate therapeutics. The candidate must have experience in late-stage process development including, but not limited to process characterization, process validation and regulatory document writing. In this role they will work as part of a multi-disciplinary team including organic chemists, chemical engineers, analytical chemists and biologists.
Qualifications : Qualifications :
- PhD in chemistry, chemical engineering, or other relevant disciplines with 5 years experience in industry setting
- Experience with late-stage process development (process characterization and process validation)
- Understanding of engineering concepts involved in Scale-up from bench to clinical to commercial manufacturing scales as well as hands-on scale-up experience to support pivotal scale manufacturing processes
- Hands-on experience in protein purification, organic synthesis, or protein conjugation
- Knowledge of statistics and understanding of DoE (design of experiments)
- In-depth knowledge of FDA regulations and guidelines as well as experience reviewing and approving CMC sections of IND and BLA regulatory submissions. Knowledgeable in European, Chinese and US CMC regulatory requirements for biologics
- Strong organizational and communication skills
- Understand and adhere to safety, quality and cGMP standards
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.
Salary : $115,000 - $160,000
