Director, CMC Gene Tx
Our client is a global biotherapeutics company. They have asked us to assist them in a search for a Director, CMC Gene Tx.
Major tasks and responsibilities include:
- Contributes to the product development strategy for the viral vector and cell products production platform.
- Establishes strategy and development of regulatory documents including quality sections for licensure submissions in target markets.
- Holds responsibility for process/product characterization strategies following risk-based methodology.
- Conducts comparability assessments
- Defines process control strategies including development of product specifications.
We seek candidates with the following qualifications
- Scopes, plans, and documents experiments to define, optimize, and characterize processes using statistically valid DoE methodology.
- Acts as a process subject matter expert to support operations with assessment of process changes.
- Supports deviation investigations and CAPAs.
- Supports strategic planning, execution, and documentation of quality department activities.
- Reports to core project teams, steering committee and established governance on progress against deliverables, timelines, and project risks.
- A PhD or Master’s of Science in biochemistry or biology, or a minimum of 7+ years of equivalent experience is required.
- Must have extensive experience in biotechnological development and manufacturing of cell and gene therapies.
- Experience in scale-up of the expression, purification, formulation, and testing of cell and gene therapies is required.
- Must have experience in working with external companies.
- Requires hands-on recent experience in validation and characterization studies for the registration of cell and gene therapies.
- Must have experience in authoring sections within regulatory submissions.
- Must be independent and capable of working for extended periods without supervision.
- Requires the ability to be able to deal with rapid change, have a strong customer service focus, and be committed to high quality outcomes.
- Must have excellent and proven people management, communication and presentation skills.
- Requires experience in managing complex cross-cultural communication between teams.
- Must have resource planning, scheduling, and budgeting experience.
- Technical and scientific protocol and report writing experience is required.
- Must have a detailed understanding of GLP, GMP, process validation, and scale up parameters.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms
and Forbes' list of Top 200 Best Executive Recruiting Firms