Director of Purification

Our Manufacturing and Process Sciences group is seeking a Director of Purification.   In this critical role, you will be responsible for providing technical, managerial and strategic guidance on the delivery of downstream processes in support of novel cancer therapies for clinical studies.  This position reports to the VP of Process Sciences and Manufacturing.

Qualifications:

  • Degree (Ph.D. or M.S.) in Chemistry, Biochemistry, Chemical Engineering or related scientific discipline. Minimum of 10 years of relevant industry experience
  • Minimum of 5 years of management and leadership experience in downstream process development
  • Knowledge of cGMP manufacturing requirements related to clinical production and commercial manufacturing
  • SME in technical operation of chromatography, UF/DF systems and clinical stage formulations.
  • Knowledge of cGMP manufacturing requirements related to clinical production and commercial manufacturing
  • Strong leader and mentor
  • Excellent verbal and written communication
  • Extremely well organized with great attention to detail
  • Able to work in a fast-paced, start-up environment
  • “Roll up the sleeves” mentality
  • Must be able to commute to Mountain View

Responsibilities:

  • Develop and scale-up phase appropriate purification processes for early and late stage process development and validation activities
  • Responsible for tech transfer of purification processes and clinical formulation to external CMO as well as internal manufacturing groups
  • Implement new purification technologies to optimize and streamline processes
  • Transfer and oversee purification process at CMO for GMP manufacturing
  • Review executed batch records from CMO manufacturing
  • Support troubleshooting issues that occur during development, scale-up and in GMP manufacturing
  • Experienced in protein purification techniques including column and membrane chromatography, filtration and tangential flow filtration
  • Working knowledge of AKTA systems and UNICORN programming
  • Strong interpersonal skills and excellent oral and written communication skills
  • Drive process improvement and metric progress in key areas of responsibility: safety/culture, quality/delivery, cost-effectiveness, and efficiency
  • Preparation of CMC documentation for regulatory submissions

Must be able to travel ~10% of the time.

IGM is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. All qualified applicants will receive consideration for employment.

 

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Posted in Manufacturing & Process Sciences.