With this goal in mind, Tizona develops next-generation immunotherapies.
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.
- 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.