Director of Analytical Development and Formulation

Our Manufacturing and Process Sciences group is seeking a Director of Analytical and Formulation.   In this critical role, you will be responsible for providing technical, managerial and strategic guidance on the delivery of stable clinical formulations and analytical methods for drug substance and drug product release and characterization.  This position reports to the VP of Process Sciences and Manufacturing.

Qualifications:

  • Degree (PhD) in Analytical Chemistry, Biochemistry, Molecular Biology or related scientific discipline. Minimum of 10 years of relevant industry experience
  • Minimum of 5 years of management and leadership experience in Analytical Development and Formulation including a commitment to mentorship and development of personnel
  • Requires a strong background in Formulation and Analytical Development, as well as a knowledge of cGMPs, ICH, and relevant FDA guidelines and experience in writing relevant regulatory submissions
  • Experience in IND-enabling stability study design and management is preferred
  • Proficiency in hands on analytical work while managing internal and external activities
  • Demonstrated ability to work independently across functional areas to design assays that can be implemented in a quality control lab
  • Excellent communication skills are required
  • Extremely well organized with great attention to detail
  • Flexibility to work on multiple projects in a fast-paced environment is essential
  • “Roll up the sleeves” mentality
  • Must be able to commute to Mountain View

Responsibilities:

  • Design and develop clinical stage formulations for IgM and IgA antibodies
  • Lead assay development activities, including method qualifications and transfers, required for clinical stage molecules
  • Provide input and data for regulatory filings
  • Actively participate in the design of specifications in alignment with control for drug substance and drug product
  • Internal and external communication with colleagues and third-party vendors to ensure optimal execution and record of analytical activities
  • Manage a team of direct reports including lead scientists
  • Support troubleshooting issues that occur during development, scale-up and in GMP manufacturing
  • 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, Uncategorized.