Technical Manager (CMC)
A life changing opportunity has arisen for a Technical Manager with an interest in CMC for Gene Therapy. In this role you will be expected to identify scientific documents to facilitate regulatory filings.
- Provide technical review and approval for process and analytical protocols, reports and other source documentation as required.
- Generate required CMC technical reports and technical documentation to facilitate regulatory filings and support technical, regulatory and quality requirements.
- Support third party vendors contracted to perform GT manufacturing or testing with expert technical knowledge to support the cGMP manufacture and testing of clinical supplies and commercial product.
- Partner with Gene Therapy External Manufacturing, CMC Quality and CMC Regulatory colleagues to support timely, value-added, stage appropriate, fit-for-purpose reporting documentation in our Gene Therapy drug development processes.
- Provide technical support for cGMP audits and batch disposition reviews of Gene Therapy facilities and products.
Skills and Requirements
- University degree or the equivalent combination of education and experience required; advanced/graduate degree preferred
- Typically requires 5 to 8 years of relevant industrial experience.
- 3-5 years of experience working with biopharmaceuticals required.
- Experience working with Advanced Therapy Medicinal Products (ATMPs), especially[D6] viral gene therapy, highly desirable.
- Excellent process development scientist, good tech knowledge and process characterisation plus QbD
- GT experience and some biologicals, worked in process development of ATMP or protiens/antibodies no small molecule please
- Ideally 8-10 years expertise and can talk fluently about the different process steps cell lines to purification
- Gone through Biological process development and validation
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