Posted Wednesday 15 January 2025 at 06:00
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.
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 that’s focused on innovation and are driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.
Main tasks and responsibilities
* Identify correct materials for procurement of development and clinical trial manufacturing supplies, drug substance, excipients, comparator and/or marketed products, final container closures, radioactive sources and other supplies, in a timely manner.
* Inform Project Scientists, Production Study Managers, Project Managers, Head of QC and other staff as appropriate, where issues with timescales are identified.
* Maintain well-organized, tidy and compliant storage areas to ensure adequate stock control and segregation.
* Undertake the following activities with regards to supplies management:
* Attend Supplies Ordering Review Meeting.
* Author risk assessment paperwork for new materials/suppliers (with QA).
* Contact suppliers to obtain quotes, lead times and samples.
* OPI ordering.
* Booking in.
* Sampling for ID (including handover to QC team) and Reference units as soon as practicable.
* Request and chase up release documentation required as per specification.
* Ensure materials are released in good time and prior to manufacturing activity commencement.
* Coordinate shipping of materials and Investigational medicinal Products (IMP) to clients or 3rd parties as applicable.
* Ensure compliant and accurate records of Clinical manufacturing materials are maintained and readily available for study specific monitoring visits.
* In conjunction with the Project Management Group and Clinical Trials Associate, plan and attend study specific monitoring visits to demonstrate accurate and compliant storage and control of sponsor provided and Quotient procured/manufactured products at all times.
* Undertake timely reconciliation and controlled disposal of client returns of development and clinical trial manufacturing supplies of drug substance, IMPs, excipients and comparator and/or marketed products as part of study close down activities.
* Maintain appropriate overhead stock controls to ensure sufficient supply volumes are maintained at all times.
* Work in a safe responsible manner at all times.
* Keep detailed and accurate records of all work undertaken, ensuring that all records are clear, concise and legible at all times to enable full repetition and traceability as per GDocP.
Qualifications and experience
* 2 years relevant experience.
* Educated to at least GCSE.
* Strong written and verbal communication skills.
Application Requirements
When applying for a position with Quotient Sciences, you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred, your application will be automatically declined.
Our Commitment to Diversity, Equity and Inclusion
Quotient Sciences is an advocate for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organization. As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today.
Specifically, we will not discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws.
This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.
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