|# of Openings:||1|
General Position Summary:
Performs synthesis, isolation, and characterization of new chemical entities for the detection and treatment of cancer and autoimmune diseases. Primary assignments include investigation into synthetic reaction pathways towards new chemical entities, development of scalable processes, facilitation of the technology transfer to relevant CMOs, generation of sufficient amounts of compounds of interest to support preclinical studies as needed, and assistance in the development of lead drug candidates (e.g. identification and generation of impurities, degradation products, and their metabolites). Support CMC efforts for IND/NDA filings and participate on interdisciplinary project teams. Works on complex problems where the analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined assignments in selecting methods, techniques, and evaluation criteria for obtaining results. Contributes to the overall R&D program. Communicates results and future plans to the R&D teams.
Key Accountabilities/Core Job Responsibilities:
· Perform laboratory studies to support process chemistry and medicinal chemistry efforts such as:
· Design experiments to understand the mechanism of degradation of investigative products including identification, preparation, and characterization of the degradants.
· Design experiments to understand the source of impurities in investigative products including identification, preparation, and characterization of the impurities, as well as Fate and Effect studies when needed.
· Collaborate with departments such as Analytical Chemistry, Bioanalytical Chemistry and Pharmaceutical Sciences to complete preliminary chemical, physical, and biological evaluation of new agents.
· Draft written progress reports and present oral progress reports at project team meetings.
· Preparation of development reports, invention disclosures, progress reports, publications and CMC sections for regulatory submissions (IND, NDA).
· Support the design, synthesis, purification, and preliminary characterization of novel small molecules directed toward the development of therapeutic agents.
· Perform routine laboratory operations such as assuring lab operations are conducted according to safety procedures and maintain detailed scientific notebook per Pharmacyclics standards
Education and Training: (degree, certifications, etc.)
· BS or BA in Chemistry with 15+ years of relevant industry experience; or MS in Chemistry with 10+ years of relevant industry experience; or Ph.D. with 5+ years of relevant industry experience
· Ability to conduct multi-step synthetic sequences, perform appropriate purifications, and acquire and interpret relevant analytical data of drug targets and intermediates, all with sound judgment.
· Good understanding of organic transformations and mechanisms relevant to small molecules
· Familiarity with manufacturing-scale equipment, processes, and procedures
· Working knowledge of current Good Manufacturing Practices (cGMPs)
· Expertise with purification and spectroscopic techniques (NMR, UV-vis, HPLC)
· Expert knowledge of scientific principles and concepts
· Familiarity with MS Word, Excel, Chem Draw computer programs
· Must be able to communicate effectively with all levels within the company and within CMOs
· Must be flexible and able to work well both as part of a team and independently
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
Are you a returning applicant?
|Back to Search Results