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Biological Sciences Jobs | Associate Director Position @ Calithera Biosciences, USA - PhD in pharmaceutical, chemical or biological sciences & 5 years exp..

Biological Sciences Jobs @ Calithera Biosciences

Biological Sciences Jobs | Associate Director Position @ Calithera Biosciences, USA: Calithera Biosciences is a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer.Our lead product candidate in tumor metabolism, CB-839, is an internally discovered, first-in-class inhibitor of glutaminase, a critical enzyme in tumor metabolism. We are currently evaluating CB-839 in three Phase 1 clinical trials in solid and hematological tumors.In tumor immunology, our lead preclinical program is directed at developing inhibitors of the enzyme arginase and may provide a first-in-class therapeutic agent for this novel target. Our ongoing research efforts are focused on discovering additional product candidates against novel tumor metabolism and immunology targets.

Biological Sciences Jobs | Associate Director Position @ Calithera Biosciences

Primary Responsibilities

  • Drug Product development and manufacturing.
  • Guide the development of processes for the formulation, manufacturing, and testing of Drug Product candidates including solution, capsule and tablet manufacturing approaches.
  • Support on-going capsule and tablet formulation development activities such as dissolution method development, excipient compatibility studies, and stability studies.
  • Conduct preformulation, formulation, analytical development, stability and other studies in support of pharmacology and toxicity studies for drug discovery programs.
  • Manage CROs conducting GMP work on Drug Product, analytical and stability testing and other R and D activities.
  • Oversee the selection of GMP drug product CROs.
  • Conduct the transfer of drug product manufacturing processes to GMP CROs and support the implementation of testing methods and stability studies at these sites.
  • Oversee all external drug product process development and manufacturing work.
  • Lead business related activities including issuance of RFPs and negotiation of service and quality agreements.
  • Prepare departmental budgets.
  • Lead the development, selection and conduct of all packaging and labeling of drug product for clinical studies.
  • Prepare technical documents for internal use and for the CMC section of regulatory filings, including INDs.
  • Conduct technical batch record review of all drug product manufacturing programs and support batch record review of drug substance analytical methods.
  • Manage project timelines and deliverables
  • Review all non-GMP and GMP in-process and release testing at CROs
  • Support in-house drug substance and drug product stability studies (non-GMP) and manage these activities at Drug Product CROs

Requirements:

  • PhD in pharmaceutical, chemical or biological sciences with a minimum of 5 years relevant industrial research and development experience.
  • Experience managing Drug Product manufacturing at CROs.
  • Thorough knowledge of small molecule preformulation and formulation development.
  • Experience with immediate release, sustained release and modified release formulation development.
  • Independent problem-solving and troubleshooting abilities.
  • Thorough knowledge of GMPs.
  • Excellent oral and written communication skills.
  • Ability to work independently as well as in a highly interactive team environment.

Biological Sciences Jobs | Associate Director Position @ Calithera Biosciences

Apply Now: hr@calithera.com

View Original Notification: http://www.calithera.com/about-us/careers/

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