The Associate Director, Cell Culture Process Development (CCPD) is accountable for and leads all aspects of cell culture process development for Sangamo's gene therapy platform focused on AAV. This role is responsible for leading cell culture development activities starting from Research, progressing through tox and clinical studies, and ultimately defining the process needed for initial IND, Phase 3, and commercial launch. Process development is also responsible for the manufacture of research grade gene therapy materials for characterization and animal testing. Given that many of these activities are on the critical path, this person will work closely with the project teams to ensure timely delivery of material and information.
- Oversee cell culture process development of our AAV platform. Lead the CCPD team through establishment of goals, plans and performance metrics that are periodically reviewed & reported to the organization
- Provide leadership and direction to the CCPD group, manage and coach junior staff
- Plan and allocate resources to meet organizational objectives
- Develop and manage CCPD group's cost & capital budgets
- Support tech transfer to manufacturing through disciplined output to Technical Operations teams
- Lead a team which has oversight for the cell culture portion of the following activities:
- Process development through IND, late stage clinical and final process validation.
- Manufacture of non-GMP materials for animal and research studies
- Clear communication with the project teams to ensure timely dissemination of information (titers, yields, purity, CPPs, CQAs, etc) and delivery of materials.
- Generation of technical reports as needed
- Authorship of CMC sections for regulatory submissions
- Provide technical support to manufacturing and CMO
- Track project activities, deliverables and completion relative to budgets and Company objectives
- Supports strategic planning by identifying development scenarios, risks and options, collaborating with Research, Program management, Clinical and internal and external Manufacturing teams
- Identify risks and assumptions in plans, anticipates problems and plans for contingencies. Removes obstacles to move work forward and/or to get efforts back on track
- Evaluates new cell culture technologies that provide advantages in the manufacturing and attainment of quality in products
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
- Minimum of a bachelor's degree in life science or engineering field; a PhD is preferred
- Minimum of 8 years relevant experience in the biotechnology or pharma industry. Direct experience with gene-based and rAAV-based therapies will be a plus
- Proven experience in developing cell culture processes leading to successful regulatory filings
- Experience with late-stage development and process characterization/validation in support of product licensure is highly desired
- Experience managing and coaching junior staff is also highly desired
- Familiar with FDA, ISO, EMA, GMP and ICH requirements
- Strong planning and tracking skills, capable of managing multiple projects, excellent time management with respect to priorities and self-management
- Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills
- Excellent written and oral communication skills
Sangamo is an equal opportunity employer
The above reflects management's definition of essential functions for this position but does not restrict the tasks that may be assigned. The above duties are representative only; management may assign or reassign duties and responsibilities to this position at any time.