Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we help biotech and pharma customers save precious time and money in getting drugs to patients.
As a growing and successful business, we employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.
Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community, driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.
- Analytical method development, validation, and transfer activities.
- APl/raw material sampling and testing, In-process and finished product testing, cleaning verification swabbing and testing.
- Notebook/report review, training, technical writing activities.
- Implementing, testing, using, or administrating LIMS.
- To comply & adhere to Good Manufacturing Practice (GMP) standards.
Main tasks and responsibilities will include:
- Independently perform routine microbiological testing procedures in support of clinical manufacturing (APl/raw materials, and drug products) according to SOPs, USP/NF, EP, and JP compendia guidelines, and standard test methods
- Environmental Monitoring of manufacturing facility including viable surface sampling, viable air sampling, non-viable air sampling and compressed air testing
- Author semi-annual and annual reports for Environmental Monitoring
- Evaluate limits and industry expectations for Environmental Monitoring as needed and justify procedure, limits, etc., as required.
- Document test results in laboratory notebook, in real-time, and communicates status of test results to supervisor.
- Maintain control of all project related samples submitted to the laboratory.
- Write and review analytical reports and author technical reports.
- Communicate with Clients regarding project timelines, data and ongoing studies.
- Review peer notebooks and analytical reports.
- Develop and identify training for other personnel
- Implement, test, use, or administrate LIMS
- Perform housekeeping to assure the laboratory is continuously maintained in a safe and orderly condition.
- Carry out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA.
- Comply with all company and site policies and procedures.
- Manage responsibilities and works in an efficient manner to assure accurate and timely data reports
- Order and maintain adequate supply of chemicals and general lab supplies to support microbiological testing.
- Independently resolve any issues with sample preparation, instrument performance, data acquisition and analysis as it applies to data integrity and accuracy.
- Remain current in profession and industry trends
- Make a positive contribution as demonstrated by making suggestions for improvement
- Learn new skills, procedures and processes including aspects of formulation development
- Is available for other duties as required
- Is available for overtime as needed
- Requires B.S. in Microbiology, Chemistry, Pharmacy or equivalent with at least 0-2 years of industrial pharmaceutical laboratory experience.
- Basic knowledge of fundamental microbiology procedures and techniques including aseptic technique, plate count procedures, and organism identification procedures is required.
In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.
Our Commitment to Diversity & Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion.
We strive to create a diverse Quotient family by remaining committed to the development of our culture, equality, mindset, diversity & inclusion in the workplace.
As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today. All applicants welcome.
If you have any questions or need some support with your application, we’d love to hear from you so contact our friendly team at email@example.com.