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 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.
- Provide microbiological expertise to quality, manufacturing, technical services, engineering and R&D throughout all phases of project including routine manufacturing, innovation, development, technology transfer, and commercialization.
- Collaborate with internal project teams, customers and supplier to ensure project deliverables are met on-time and within budget.
- Comply with and continuously promote adherence to current Good Manufacturing Practices (cGMP) across the organization.
- Serve as a role model to foster a culture of quality and instill a continuous improvement mindset; ensure the integrity of data and quality of work as a first priority.
Main tasks and responsibilities will include:
- Anticipate/evaluate technical problems and provide recommendations for corrective actions.
- Independently perform routine microbiological testing procedures and data analysis 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
- Oversee and ensure compliant execution of Environmental Monitoring program of manufacturing facility including viable surface sampling, viable air sampling, non-viable air sampling and compressed air testing
- Conduct data trending and analysis and 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.
- Ensure procedures governing the Environmental Monitoring program and other microbiological control programs are maintained in accordance with current regulatory requirements and industry expectations.
- Document test results in laboratory notebook/ELN, in real-time, and communicates status of test results to stakeholders.
- Maintain control of all project related samples submitted to the laboratory and ensure timely processing.
- 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 to evaluate raw data for acceptability.
- Develop and identify training for other personnel. Serve as a coach and mentor across the organization on microbiological programs.
- Ensure 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
The job may involve the following:
- Very high concentration of work
- Strict and tight deadlines
- Having to juggle a range of tasks/issues simultaneously
- Working in a hazardous environment with high requirement to follow safety procedures
- Working outside normal working hours
- Needing to respond to client demands
- Requires B.S. in Microbiology, Chemistry, Pharmacy or equivalent with at least 8 years experience or M.S or Ph.D in Microbiology, Chemistry, Pharmacy or equivalent with a minimum of 4 year of industrial pharmaceutical laboratory experience or a combination of equivalent training, experience and education.
- Advanced knowledge of 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 firstname.lastname@example.org.