Pharmacyclics Careers

Senior Scientist

Location: Sunnyvale, CA
# of Openings: 1

Description

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:

  • Optimization of current synthetic procedures for manufacturing kg quantities of lead development compounds, while scouting alternative routes
  • Problem solve chemical process (i.e. impurity identification and source)
  • Lot production of up to 1kg of non-GMP APIs and intermediates
  • Collaborate with contract research and manufacturing organizations working for Pharmacyclics to deliver lead compounds
  • Synthesis of new compounds to produce 1-100 gram quantities for PK and toxicology studies, while identifying route liabilities

·         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

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

  • Excellent verbal and written communication skills, team player, flexible to change in responsibilities

·         Familiarity with MS Word, Excel, Chem Draw computer programs

  • Demonstrated technical proficiency, scientific creativity, collaboration with others and independent thought.
  • Experience in writing and reviewing CMC sections of INDs

Specific Skills/Abilities

·         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

  • Must be able to make recommendations based on sound logic and data analysis which contribute toward key decisions
  • Must have hands-on process development and scale-up experience
  • Ability to speak Mandarin a plus

Equal Opportunity Employer Minorities/Women/Veterans/Disabled





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