Job Introduction We are looking for:
A Scientist in Analytical Sciences(12 months Fixed Term Contract) to deliver and support the leading of a wide range of activities associated with the optimization, phase appropriate validation, transfer, and application of analytical methodologies suitable for in-process development testing, non-GMP and cGMP release testing of biological products. At Pharmaron we offer:
A Scientist in Analytical Sciences(12 months Fixed Term Contract) to deliver and support the leading of a wide range of activities associated with the optimization, phase appropriate validation, transfer, and application of analytical methodologies suitable for in-process development testing, non-GMP and cGMP release testing of biological products. At Pharmaron we offer:
- Vibrant and dynamic employment –we are a highly specialised, growth company operating in a critical sector of the economy – our future is strong and exciting!
- Opportunities to develop your skills and yourself – our rapid growth brings greater opportunities for you to learn and grow faster!
- A great team where we all support each other – enjoy your work – after all you spend about a third of your time here!
- Support Project leads on delivery of internal and Client-based work packages through the planning, design, delivery and reporting of activities within the QC analytical laboratories to meet project timelines in line with policies and procedures.
- Ensure maintenance of stock reagents and consumables and laboratory housekeeping for all work performed.
- The preparation and execution of a range of documentation including but not limited to development reports, operating procedures, phase appropriate validation, analytical proformas and test records in a timely manner with a right first-time mind set.
- Drive 5S and operational excellence initiatives as a means for continuous improvement to ensure that department is a high performing team.
- Lead on the delivery and validation of new capital equipment items and train others in procedures, techniques, equipment, and technologies to increase Biologics QC analytical capabilities.
- Analyse any data to a high standard and ensure that protocols and procedures are delivered with a high attention to detail.
- Lead on associated QMS including but not limited to Non-Conformances, CAPA’s, Out of Specification and Change Controls.
- Complete all laboratory or batch related documentation in a timely and compliant manner, participating in reviews of the documentation to obtain quality sign off when necessary.
- Subject matter expert in areas relating to QC analytical, including but not limited to Biological GMP analytical testing for separation and plate-based analytics.
- Set exemplary standards within the laboratory and facility in compliance with Development, Quality and EHS Policies and Procedures.
- BSc/MSc (or equivalent) in a relevant life sciences field with biopharmaceutical or pharmaceutical experience.
- Proven industrial experience within the biopharmaceutical or pharmaceutical industry (gene therapy most ideal). Working in Quality Control, performing equipment qualification, phase appropriate validation and testing.
- Working knowledge of areas within Analytical Sciences including but not limited to Electrophoresis (SDS-PAGE, Western Blot, cIEF, CE-SDS), Chromatography (SE-UPLC, RP-HPLC, AEX, HILIC), Immunoassays (ELISA, Potency, HCP), Molecular Biology (qPCR, ddPCR, sequencing, residual DNA)
- Knowledge of regulatory guidelines and GMP regulations.
- Knowledge and experience in the use of statistical techniques for the planning/ analysis of experiments and handling large amounts of data.
- Effective organizational and time management skills.
- Effective written and communication skills, (including presenting).
- Strong analytical skills with the ability to interpret results and solve complex problems with an appreciation of business needs.
- We offer a competitive salary and a progressive and comprehensive suite of employee benefits
- We offer state of the art working environment in our modern Liverpool site
- We offer the opportunity for growth and development and will support funding for relevant training and development programmes
- This is an opportunity for you as a science professional to make a real impact in a highly scientific and regulated environment, demonstrate leadership, ambition and the desire to grow with the department.
- Build and shape your career in an environment that sets and commits to the highest standards.
- To be part of a team who support each other, embrace and solve technical challenges and put excellence at the heart of all that we do.