Process Development Senior Scientist
$126,066–$170,559 year
On-siteCambridge, Massachusetts, United States or Thousand Oaks, California, United States
Job Summary
Process Development Senior Scientist responsible for development, characterization, scale-up and support of drug substance processes to enable commercialization of programs from Ph II/III trials. Works with cell-culture and purification scientists to advance biologics modalities (including antibodies, bispecifics, oncolytic viruses, and siRNAs). Delivers cGMP-compliant manufacturing processes for late-stage programs, authors or directs CMC/regulatory submissions, and contributes to cross-functional teams with analytical and drug product representatives. Requires strong experience in bioreactor/process development, DOE, statistical analysis, and technical communication, with leadership capability to guide a team of scientists toward defined timelines.
Required Qualifications
- Doctorate degree OR Master’s degree and 4 years of life sciences experience OR Bachelor’s degree and 6 years of life sciences experience OR Associate’s degree and 10 years of Engineering experience OR High School diploma / GED and 12 years of Engineering experience
- Experience in bioreactor process development or cell line development
- Scientific understanding of current bioreactor technologies
- Knowledge of license application and the drug development process
- Familiarity with design of experiments and statistical analysis of data
- Exposure to cGMP manufacturing and CMC components of regulatory submissions
- Strong technical communication skills to interact with stakeholders and document improvements
- Leadership experience with ability to inspire and lead a group of scientists
- Demonstrated eminence in the scientific community through peer-reviewed publications
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