Kezar Life Sciences (NASDAQ: KZR), a clinical-stage biotechnology sciences company located in South San Francisco, is seeking a Scientist to join our Pharmaceutical Development team. This position will involve conducting pre-formulation, formulation development, and overseeing tech transfer and manufacturing activities with the goal of developing robust oral and parenteral formulations for preclinical and early phase in support of our smallmolecule immunology and oncology programs. The successful candidate will be part of a dynamic, interdisciplinary team and requires a high degree of creativity and initiative. This is an exciting time to help drive the development of novel therapies for unmet needs in multiple indications.
Kezar is focused on small molecule drug discovery and development to target immune-mediated diseases and cancer. Kezars lead product candidate, KZR-616, a selective inhibitor of the immunoproteasome, is being evaluated in Phase 2 clinical trials for the treatment of severe autoimmune diseases. KZR-261, Kezars first oncology candidate targeting the protein secretion pathway via the Sec61 translocon, is now being studied in a Phase 1 clinical trial in several oncology indications.Responsibilities
- Supports Drug Product development activities from research stage through cGMP manufacture in a phase-appropriate manner for various dosage forms, especially Parenteral formulations.
- Participate in drug product manufacturing technology transfers, CMO/CRO oversight activities, and analytical method transfers.
- Takes an active role and applies subject matter expertise in formulation development of small molecules.
- Implements Quality by Design (QbD) and applies risk-based principles to establish the Quality Target Product Profile and required Critical Quality Attributes & Critical Material Attributes.
- Review and QC of batch records, analytical data packages; provide technical input toward batch release.
- Manage, set up and maintain all the equipment in the formulation lab.
- Perform tasks per protocols and develop new protocols as needed.
- Approximately 10 % travel may be needed for scientific project management and monitoring of critical project activities.
- Additional responsibilities may be added as required.
Kezar Life Sciences is an Equal Opportunity Employer
- MS with 3-9 years or Ph.D. with 0 2 years of experience in pharmaceutical sciences, chemistry, chemical engineering, or related discipline.
- Strong knowledge of small-molecule formulation development and characterization. Parenteral experience is preferred.
- Hands-on laboratory experience in pre-formulation, solid-state/physicochemical, and thermal characterization.
- Good understanding of organic chemistry.
- Expertise in HPLC and other small-molecule analytical techniques.
- Experience or working knowledge of analytical methods and tests used to characterize formulations and finished drug products, such as compendial tests related to parenteral and solid oral dosage forms.
- Independent problem-solving and troubleshooting abilities.
- Technical writing experience such as protocols, reports, and SOPs.
- Ability to communicate scientific findings and recommendations in one-on-one discussions, departmental meetings, and written reports.
- Proficiency in preparing presentations using PowerPoint.
- Ability to work in a fast paced, dynamic environment with multiple projects, priorities, and personalities.
- Demonstrated track record in successful formulation development programs.