Please Note: The application deadline for this job has now passed.
Job Introduction
Senior Manager, Microbiology
We are looking for:
An experienced Senior Manager to play a pivotal role in overseeing the daily operations, strategic direction, and quality of our Microbiology service. You will collaborate with a team of dedicated professionals to ensure accurate and timely reporting of facility and product testing, including method and equipment validation in adherence to regulatory standards.
You will have excellent knowledge and understanding of MHRA & FDA regulations. You will have experience of providing support to the Manufacturing group and product testing of Bioburden and endotoxin testing.
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:
- BSc or equivalent in Biological discipline
- Experience in line management of both functional and cross functional teams.
- Experience in regulatory and client audits for GMP compliance.
- Experience with analysis of pharmaceutical/ biopharmaceutical products.
- Experience of quality systems within a GMP facility – CAPAs, Out of Specifications, Deviations, Change Control Requests.
- Experience of working in CDMO / CRO environment
- Experience in the use of statistical techniques for the planning and analysis of experiments.
- Experience in writing technical specifications, method validations and test methods.
Knowledge & Skills
- Knowledge of pharmaceutical standards and regulations, GMP.
- Working knowledge of analytical techniques including but not limited to:
- Clear understanding of the science and a passion for keeping abreast and implementing analytical advancements.
- Excellent data analysis skills with the ability to analyse, interpret results both reporting and communicating experimental findings effectively.
Key roles and responsibilities:
- Ensure cGMP readiness for manufacturing activities by ensuring appropriate procedures, specifications, facility monitoring, and equipment and methods are appropriately validated in line with quality procedures and guidelines
- Supervise the development, optimization, qualification and/or technical transfer of methods and the validation/verification of compendial or developed assays for cGMP testing.
- Supervise and plan testing of facilities/utilities, raw materials, process development and in process, product release and stability to ensure delivery on time, on budget and in compliance with the established quality standards.
- Write and review technical reports for issue to the client or inclusion to support internal Regulatory Submissions.
- Manage lab areas, including supervision of scientists, resolve day to day equipment or technical issues and escalate issues when necessary to Director, Analytical Sciences.
- Manage and develop the QC MicrobiologyTeam through annual PMP targets, Individual development plans and monitor accordingly.
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
- 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 Hoddesdon site.
- We offer the opportunity for growth and development and will support funding for relevant training and development programmes.
Why Should You Apply?
- This is an opportunity for you as a Microbiology 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 of Microbiology.
- 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.
Founded in 2004, Pharmaron is a cutting-edge, fully integrated pharmaceutical R&D service platform supporting the life science industry. The company has invested in its people and facilities and established its comprehensive service offerings throughout the pharmaceutical R&D lifecycle. With operations in China, the US and the UK staffed by more than 19,000 employees, Pharmaron has an excellent track record in delivering end-to-end R&D solutions to its partners globally and enabling them to accelerate their novel drug discovery and development process.