Director, CMC

Here at Tizona Therapeutics, we value Patients First!
With this goal in mind, Tizona develops next-generation immunotherapies.
 
The successful development of immunotherapies represents one of the most important and exciting breakthroughs in cancer. Despite the recent progress in the field of immuno-oncology, existing immunotherapies are only effective in a relatively small number of patients and types of cancer – a limitation that we hope to overcome.  
 
Tizona’s therapies are designed to modulate the activity of immunosuppressive cells by targeting the cell types and biological mechanisms responsible for immune suppression in the tumor microenvironment. 
 
 

General Position Overview:

We are seeking for an outstanding Director of CMC who will lead the development and manufacturing efforts to advance Tizona’s pipeline of pre-clinical and clinical stage antibody therapeutic candidates. This position will report directly to the CTO and serve on Tizona’s Product Development teams composed of experienced industry consultants and in-house representatives from clinical, regulatory, quality and process development.  The job will require managing and leading product development and manufacturing activities both in-house and by outsourcing through Contract Service Providers (CSPs).  In-depth knowledge and experience with state of the art cGMP manufacturing and process development strategies and practices for the manufacture of Biologic products (Phase I through commercial production) and demonstrated management and leadership skills are essential.

 

Essential/Primary Duties, Functions and Responsibilities:

  • Assist in establishing strategies for process development and manufacturing to support Tizona’s preclinical and clinical programs.
  • Prepare and review RFPs and quotes for CSP activities.   Make recommendations to management on best course of action based
  • Participate in on-site cGMP audits of CSPs for GMP compliance.
  • Assist Tizona’s Quality Lead in establishing Quality Agreements with CSPs.
  • Prepare status reports and presentations to update project teams and senior staff.
  • Serve as an interface with CSPs and manage outsourced manufacturing, QC and process development activities. 
  • Support Tizona’s antibody pipeline from preclinical to commercial including IND/INDa preparation, cell line development, upstream and downstream development, QC, analytical assay and process validation.
  • Provide guidance and resolve issues between Tizona and CSPs.
  • Review batch records and reports from CSPs.
  • Implement and follow good documentation practices for protocols and records related to collecting and recording data, providing signatures, and making corrections, annotations or changes to manufacturing and development related documentation.
  • Coordinate technical reviews and approvals of draft Master Batch Records (MBRs) with technology experts and consultants prior to their use in GMP manufacturing.
  • Work with contractors and consultants to develop appropriate product release specifications and process related documentation.
  • Participate in the evaluation and resolution of process and manufacturing related deviations related to GMP production activities at CSPs.

 

Other Responsibilities Include: 

  • Help set corporate strategy for formulation, analytical, process development and manufacturing objectives consistent with achieving company goals within company budget and timeline constraints.
  • Contribute to the writing and review of the CMC section of regulatory submissions.
  • Foster cross-functional thinking and work collaboratively with multiple Project teams to ensure CMC objectives are appropriately executed and managed in support of Tizona’s corporate objectives for ongoing projects.
  • Represent Tizona as a Manufacturing and Development subject-matter expert for corporate and regulatory auditors.

 

Key Requirements:

  • M.S. or Ph.D. in biochemistry, chemical engineering or related discipline
  • Eight or more years of hands-on experience with both early and late stage Biologic development, cGMP manufacturing and process validation.  Understanding of ICH guidelines and industry best practices.
  • Proven strength in scientific analysis. Familiar with state of the art analytical and Biologics development strategies.
  • Proven CMC Leadership and Management skills, including managing CSPs.
  • Strong written and oral communication skills and experience writing and reviewing CMC sections for regulatory submissions.
  • Experience in analytical methods development and validation is a plus.
  • This position will require travel to domestic and international vendor sites.

 

 
Tizona Therapeutics is an Equal Opportunity Employer. We value diversity and are committed to providing employees a workplace free of discrimination and harassment. All employment decisions are based on qualifications, merit and business needs.

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