Director, Analytical Development and Quality Control

San Diego, CA

Imbria Pharmaceuticals’ mission is to translate our understanding of cellular metabolism into innovative medicines that improve the lives of patients with limited or inadequate treatment options. The company was founded by doctors and launched by an all doctor executive team motivated by the promise of bringing new therapies to people in need.

We are propelled by a deep scientific interest in cellular metabolism and the mitochondria, and are guided by both values and a code of business conduct built upon our commitment to always put the patients, families and communities we serve at the forefront of all that we do. More information can be found at www.imbria.com.

 

Director, Analytical Development and Quality Control

Job Description

Position Overview

Imbria is seeking a director of Analytical Development and Quality Control for small molecule drugs. This highly cross-functional role will be responsible to direct method development and validation activities for drug substances and drug products, managing stability programs, and ensuring batch-to-batch quality of drug substances, drug products and raw materials.

The qualified individual will report to the Head of Technical Operations and Manufacturing and will provide leadership for multiple hands-on projects as well as facilitate team interactions among a diverse group of people within technical operations, regulatory and quality, and the clinical operation teams. Successful integration with the CDMOs’ analytical/QC functions will also be essential for this role.

Key Responsibilities

Analytical Development:

  • Establish robust analytical CMC development strategies, plans, timelines and track project status.
  • Direct method development, validation, and continuous improvement activities for control of raw materials, drug substance, bulk drug product and finished drug products.
  • Develop specifications for raw materials, drug substance, bulk drug product, and finished drug products.
  • Act as technical subject matter expert in analytical chemistry, supporting cross-functional product development program.
  • Scientifically advises CDMO team on analytical methods across the board.
  • Support key product claims through analytical testing methods as needed.
  • Review and approve development reports.

Quality Control:

  • Review and approve method validation protocols and reports.
  • Participate and support investigations and root cause analyses with CDMO QC labs.
  • Conduct data reviews and trending analyses with CDMO QC labs.
  • Draft, implement, and train on the quality control related SOPs. Partner with Quality Assurance to ensure that SOP’s are in place and followed.
  • Monitor testing with CDMOs.
  • Develop effective and efficient processes to manage stability program including stability study design, execution, monitoring, reporting, and data trending and analysis.
  • Preparation of CMC analytical sections in regulatory filings.

Qualifications

  • A degree in Chemistry, Pharmaceutical sciences, Chemical Engineering or related scientific discipline (MS with 10 years, or PhD with 7 years of relevant industry experience).
  • 5-10 years of hand-on experience together with at least 10 years managing projects and CDMOs
  • Extensive method development experience, proven problem-solving skills, and strong critical thinking ability.
  • Highly motivated to interact cross-functions and CDMOs; embracing change and risk, and exhibiting flexibility.
  • Very strong interpersonal skills. Must possess an ability to enact positive quality change within the organization.
  • Exhibits excellent organization, planning and multi-tasking skills; must be capable of handling multiple projects/tasks at the same time.
  • Experience compiling and writing technical packages for IND/IMPD filings including a working knowledge of cGMP manufacturing and all applicable FDA and EMA regulations.
  • Demonstrated ability to manage multiple development projects and CROs/CDMOs simultaneously.
  • Experience generating and overseeing development plans for quality control from preclinical through commercialization.
  • Critical thinker with exceptional decision making and problem-solving abilities.
  • Excellent written and verbal communication skills, including writing executive summaries and communicating with senior level operations, quality management team and regulatory agencies.
  • Familiarity with the use of Software tools such as Excel, Word and PowerPoint, PDF and their application

Location and Travel

  • The role is to be based in San Diego.
  • Travel is estimated to be approximately 20% for this position.

Imbria offers an attractive salary and benefits package, including equity incentives. To apply, please submit your resume to hr@imbria.com.