CMC Technical Manager for Gene Therapy
- Maidenhead, United Kingdom
To have detailed technical knowledge of GT CMC operations and processes and to have ownership and oversight for the appropriate reporting of process development, manufacturing and testing documentation and reports. To ensure CMC source documentation is in place on time and in compliance with scientific, technical, quality & regulatory requirements and guidelines.
Identify and/or generate, as required, additional CMC technical reports and supporting scientific documentation/publications to facilitate regulatory filings or regulatory authority requests for technical information. Authoring of Module 3 sections for Regulatory filing authorisations.
When required to, effectively interact with external Gene Therapy contract manufacturers and testing organizations as well as internal multidisciplinary Asset sub-teams to ensure technical/scientific execution and reporting is in compliance with scientific, technical, manufacturing and testing instructions, timeliness, and applicable cGMPs.
Provide technical support for batch/vendor auditors to enable timely execution of product release/audits and technical review and approval of deviation/audit reports and responses. Note: this role is not responsible to conduct audits but to support Quality in this activity.
To form close partnerships with Gene Therapy Process Development, External Manufacturing, CMC Quality and CMC Regulatory functions and to provide expert technical input, opinion and consultancy.
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.
Authoring Module 3 Regulatory filing sections
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.
Minimum Education Requirements
University degree or the equivalent combination of education and experience required; advanced/graduate degree preferred
Minimum Experience Requirements
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 viral gene therapy, highly desirable.
All your information will be kept confidential according to EEO guidelines.
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