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Associate Director, CMC Drug Substance

Status: Archived
Companyzentalis
LocationSan Diego, California
Expiration2021-09-14
How to Apply

https://zentalis.bamboohr.com/jobs/view.php?id=75

Zentalis Pharmaceuticals is a San Diego-based pharmaceutical company dedicated to the discovery and development of small molecule therapeutics targeting fundamental biological pathways of cancer. In the six years since our inception, we have successfully cleared four INDs with the FDA.  We believe our deep pipeline of oncology therapeutics has the potential to significantly improve the lives of patients with various types of cancer.

 

SUMMARY:

This position will be responsible for providing technical and managerial leadership, project management and oversight of drug substance process development and manufacturing activities in support of Zentalis’ clinical programs across all phases of development.

 

RESPONSIBILITIES:

  • Independently manage molecule drug development projects
  • Develop cost efficient, scalable and robust drug substance manufacturing processes
  • Establish drug substance (including the related raw materials and intermediates) development strategies and operational plans across a portfolio of projects, and ensure that they are aligned with the strategic and operational objectives of other functions, and of the company
  • Participate in the selection and qualification of third-party suppliers for drug substance process development and manufacturing
  • Oversee contract drug substance process development and manufacturing operations at third-party service providers
  • Prepare supporting regulatory documentation
  • Collaborate with other functions to assure compliance with applicable GxP and global regulatory requirements
  • Ensure budget, schedules, and performance requirements are met
  • Support regulatory filing for the development programs

 

REQUIREMENTS:

  • Minimum MSc (Ph.D. preferred) in chemistry or chemical engineering
  • Minimum of 12 years’ industry experience in drug development
  • Strong knowledge of US and EU cGMP requirements and best practices relating to drug substance
  • Strong knowledge of & good experiences in drug substance process development and manufacture across all phases of drug development from initial regulatory filings through registration, validation and launch
  • Experience in managing multiple third-party contract manufacturers and associated service providers
  • Excellent communication skills, both verbal and written, as demonstrated through prior work experience keeping key stakeholders and management informed of status, issues and recommended solutions
  • Excellent planning and organizational skills
  • Ability to think intuitively and problem solve
  • Ability to be successful in a fast pace, small, start-up environment
  • Able to manage shifting priorities
  • Ability to travel
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