Tech Transfer Lead
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Hobson Prior are currently working with a late-stage biotech organisation specialising in improving health all over the world through discovering, developing and commercializing pioneering vaccines to prevent serious diseases. Our client is seeking a Tech Transfer Lead to join them on a permanent basis based in Maryland.
- Accountability for drug substance technology transfer activities from preclinical development through commercial supply.
- Identification, selection and management of Contract Development and Manufacturing Organizations for process optimization, cGMP manufacture and supply of DS in support of ongoing clinical programs.
- Delivery of robust, scalable and cost-effective manufacturing processes that meet or exceed the target clinical profile.
- Provide technical/team support and leadership for technology transfer, and qualification studies associated with the development and implementation of processes, systems and facilities related to vaccine drug substance and key intermediates e.g. media, buffers and cleaning solutions.
- In coordination with Quality Assurance, implement stage appropriate analytical methods and protocols and ensure that all CDMOs are using systems and processes in compliance with all relevant regulatory standards.
- Oversee execution of the validation of DS processes as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations.
- Assisting with the writing and reviewing documents for INDs / regulatory section submissions.
- Prepare, review, or edit cGMP batch records, CMC regulatory, and Quality documents.
- Provide input on process development strategies, overseeing CDMO development through clinical and pre-commercial stages.
- Co-operating with other CMC team members to build and execute the CMC development plan.
- Strong program management and project management skills and adept at working collaboratively with cross functional teams.
- Strong interpersonal and communication skills.
- MS or BS in engineering, chemistry, biology, or related discipline, plus at least 4 years of experience in pharmaceutical or biological operations.
- Proven experience in collaborating in matrix teams in a technical environment.
- Experience in oversight of CDMOs for process development, characterization, technology transfer, and release.
- Knowledge of CMC development from pre-clinical through clinical to commercialization.
Knowledge of protein production and purification manufacturing technologies, such as:
- Cell culture
- Shake flasks and stirred tank bioreactors
- Clarification by depth and tangential flow filtration
- Column chromatography
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
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