Senior Scientist/Group Leader CMC analytical developmentRole Type: PermanentSalary: Dependent on Experience/Level of roleSkills: Protein Analysis, UPLC, Antibody, CMC, analytical processesMy client based in the Cambridge...
Senior Analytical Development Manager
Up to £48k per annum
Working for a global organisation based in Cambridge, this role is responsible for the progression of analytical development and laboratory informatics as applied to innovative development and optimisation of pharmaceutical products. In this role you will contribute to analytical testing, method validation and development projects.
Core role requirements:
* You will be expected to manage the Analytical Development activities within the Biologics team.
* To work with change controls, CAPA's, risk management and quality issues and ensure any corrective actions are taken as required.
* Support the design and optimisation of biologics activities, sampling and analysis of raw materials, intermediates and finished product.
* Working to prescribed ISO and FDA regulations to ensure all regulatory compliance is in accordance with agreed project timelines and budgets as well as best scientific practice regarding development, validation and transfer of analytical methods, QC release and stability testing in regards to clinical trials and regulatory submissions.
* Working with both upstream and downstream drug substance/product processes to ensure they meet appropriate testing standards.
* Management and control of the Analytical Testing budget, projecting where investment is required and planning to ensure coverage from the project team to benefit the wider business.
* Manage and evaluate materials required, training and development plans and constant review of regulatory guidance relevant to the area of drug development and design.
* Drafting of validation, development and design of analytical methods, technology transfer and compliance with the methods used in such transfers.
* Degree or beyond in a relevant Chemistry discipline (or related) or equivalent
* Demonstrable background in analytical chemistry and development for biologics/biosimilar formulations, along with a background in CMC/regulatory guidelines and filings
* A strong work background of complying with GMP/GLP within an analytical environment.
* Proven industry experience of working with regulatory inspections and guidelines
* Proven background of working with quality management systems and risk assessment for biosimilars or biologics products.
* Good working knowledge of H&S requirements such as COSHH and HASAWA.
* Excellent communication and listening skills, able to build networks both internally and externally and contribute to the bigger picture.
* Highly professional, articulate and engaging in your approach. Good influencing skills and able to work to deadlines in a busy and evolving area of science. Does this describe your next role?
If so, please apply direct or contact Bec Johnston for further information: firstname.lastname@example.org / 01223 607858