Job description
We are looking for:
This position delivers and supports leading 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!
Requirements:
The successful candidate will have responsibilities for:
- Set exemplary standards within the laboratory and facility in compliance with Development, Quality and EHS Policies and Procedures.
- Supporting 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.
Key roles and responsibilities:
Essential:
- BSc/ MSc (or equivalent) in a relevant life sciences field with biopharmaceutical or pharmaceutical experience.
- Proven experience within the biopharmaceutical or pharmaceutical industry (gene therapy most ideal). Working in Quality Control, performing equipment qualification, phase appropriate validation and testing.
- Knowledge of regulatory guidelines and GMP regulations.
- 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 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.
- Excellent attention to detail and a methodical approach.
- Work within and contribute to a multi-disciplined environment and work effectively as part of a dynamic team.
- Strong analytical skills with the ability to interpret results and solve complex problems with an appreciation of business needs.
- Ability to set up new initiatives and propose new/ improved ways of working.
- High attention to detail and can demonstrate sound scientific opinion in written and oral interactions.
- Flexible attitude to work, capable of adapting to changing demands and requirements.
- Strong organisational skills with the ability to manage/ prioritise workloads for various project types to meet project timelines.
Desirable:
- Experience of taking responsibility for leading some activities within the design and delivery of projects.
- Evidence of ability to effectively influence to multi-disciplinary scientific teams.
- Experience in writing procedures, protocols, and reports.
- Clear understanding of science and a passion for keeping abreast and implementing analytical advancements/ new technologies.
Our Company: “We are a dynamic, fast-growing company, with an enviable reputation for leading edge science, offering contract research services to some of the world’s leading pharmaceutical companies, solving what were believed to be unsolvable scientific challenges”.
We believe in our ability to relentlessly push forward the boundaries of scientific excellence, delivering solutions for our clients, always operating ethically and with integrity. We take pride in our professionalism and commitment to always deliver our very best work.
We are based in the vibrant city of Liverpool with a world class R&D and manufacturing facility that offers a complete end to end development service. Our 80,000 sq. ft facility houses an established Biologics Department that consists of Analytical and Process Sciences. Our Liverpool site has a remarkable 20 Year Track Record in Biologics Development, which now offer A Fully Integrated
Gene Therapy Drug Substance Solution in our state of the art cGMP facility purpose designed for viral vectors with onsite plasmid DNA and renowned analytical capabilities for release and characterisation
The Pharmaron Liverpool Team has consistently delivered biologics programs across all development phases and due to constant growth we are now recruiting an Scientist, Analytical Sciences (QC).
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
We do more than manufacture batches, we develop medicines!
Why Should You Apply?
- This is an opportunity for you as a Scientist, Analytical Sciences (QC) 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.
Pharmaron is a premier R&D service company supporting the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities having established diverse drug R&D service capabilities, ranging from synthetic, medicinal, and analytical chemistry, biology, DMPK, pharmacology, drug safety assessment, radiochemistry and isotopically labelled metabolism, chemical & pharmaceutical development to clinical development. With operations in China, US and UK staffed by over 19,000 employees, Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan, and China.