Lana Premadasa is currently recruiting for an experience CMC Technical Specialist for a world leader in Gene and Cell Therapy at their site in Oxford on a full time permanent basis.
The role is as an office-based technical specialist and author to provide Chemistry, Manufacturing and Controls (CMC) technical input into the company's projects and those of their external clients. The role includes overseeing CMC studies to ensure on-time delivery for project deadlines. In addition to liaising with staff across all operational departments, the successful applicant will also be required to build and maintain collaborative relationships with external organisations.
Key responsibilities and accountabilities will include:
- Collaborate with external partners to provide CMC technical support where company technologies are employed.
- To support and/or coordinate studies or activities for regulatory applications within defined project deadlines
- Support provision of high-quality documentation (e.g. technical protocols and reports) related to CMC sections of clinical trial applications and INDs, Marketing Authorisation Applications (MAAs) and Biological Licence Applications (BLAs).
- Provide input for improvement of CMC technical development strategy, to keep it up-to-date with the evolving scientific and competitive environment.
Further responsibilities will include:
- Working closely with company staff and project team members of client organisations to ensure delivery of CMC source documentation in support of regulatory submissions.
- To author plans/protocols and reports and co-ordinate CMC-related studies e.g. Comparability protocols and reports
- To review CMC-related documents drafted by other company departments to ensure that they meet regulatory and client expectations. To review CMC-related text incorporated into regulatory documentation to ensure accuracy and consistency with source documents
- To advise on the scope and impact of manufacturing and analytics planned changes and quality incidents.
- To advise on analytical specifications to meet regulatory and client requirements, and to advise on corresponding acceptance limits
- To attend interdisciplinary project team meetings and provide updates on CMC-related activities.
Key skills and requirements for this position will include:
- Educated to a minimum of Degree in a relevant scientific discipline, or equivalent qualifications and/or experience.
- Knowledge of GMP-compliant manufacturing and/or analytics for biological medicinal product to support clinical development and commercial scale-up.
- Previous experience of drafting high quality documentation such as technical reports.
The company values include ambition, recognition and innovation; enabling them to commit to solving unmet medical needs. If this sounds like the sort of environment that you would like to work in, then we would love to hear from you.
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference ST41968 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Posted: 26th April 2018
- Expires: 24th May 2018
- Reference: ST41968