Director, CMC Gene Therapy
Our client is a global biotherapeutics company. They have asked us to assist them in a search for a Director, CMC Gene Therapy.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Contributes to the product development strategy for viral vector and cell products production platform.
- Establishes strategy and leads development of CMC regulatory documentation.
- Is responsible for process and product characterization strategies following risk-based methodology.
- Is responsible for comparability assessments.
- Defines process control strategies including development of product specifications.
- Supports small-scale experiments using statistically valid DoE methodology.
- Supports operations with assessment of process changes, supports deviation investigations and CAPAs.
- Provides oversight to other aspects of the development process.
- Supports strategic planning, execution, and documentation of Quality Department activities.
- Regularly reports to Core Project Teams, Steering Committee, and established governance on progress against deliverables, timelines, and project risks.
- A PhD or Master’s degree in Biochemistry/Biology, BE or minimum 7 years of experience is required.
- Requires extensive experience in biotechnological development and manufacture of cell and gene therapies.
- Must have technical experience in cell and gene therapies.
- Experience in working with external companies is required.
- Requires recent experience in validation and characterization studies for the registration of cell and gene therapies.
- Experience in authoring sections within Regulatory submissions is required.
- Must be independent and capable of working for extended periods without supervision.
- Must 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.
- Must have experience in managing complex cross-cultural communication between teams.
- Resource planning, scheduling, and budgeting experience is required.
- Technical protocol and report writing skills are required.
- Must have a detailed understanding of GLP, GMP, process validation and scale up parameters.
- Must be fluent in English.
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.
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