Analytical Tech Transfer
Proclinical has partnered with a global biotechnology in search for a talented Analytical Tech Transfer. This role will provide overall scientific and strategic leadership for the bio analytical team. This is 12 months contracted role out of Cambridge with the possibility of an extension.
- Responsible for developing pragmatic implementation plan, by working with stakeholders from cross functional areas
- Responsible for ensuring harmonised compliance to internal standards and policies related to analytical operations supporting third party suppliers
- Foster creative collaborations between R&D, Operations and the third-party suppliers to progress the projects and coming up with win/win solutions
- Author/Review technical documents in the subject matter for regulatory submissions as needed
- Provide input and review for regulatory filings to ensure consistency in depth of content and strategic approach
- Provide forward thinking in anticipation of future needs
Skills and Requirements
- MS or PhD in Biological Sciences required; 10-12 years relevant experience with a MS or 6+ years relevant experience with a Ph.D
- Experience in cell culture, Immuno assay, PCR, next generation genome sequencing, biologics, residuals and impurities assay, analytical method development, transfer and method validation-
- Has a working knowledge of biosafety testing and microbiology requirements in a manufacturing environment
- Analytical method development and validation experience; knowledge of cGMP practices and ICH requirements
- Leadership experience in leading global team and working with CMO is essential
- Ability to work effectively in a team-based environment as well as cross- functionally
- Ability to manage complexity and adapt to changing priorities
- Has demonstrated leadership through project team participation, internal consulting and mentoring
- Ability to make timely and defensible decisions and conclusions
- Demonstrates the ability to effectively explain complex scientific concepts to a broader, diverse audience.
- Proficient in project management and stakeholder management skills
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.