Process Support Coordinator
Process Support Coordinator
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.
Quotient Sciences are expanding rapidly, with a clear commitment to drug substance development and manufacture and have recently opened an $8m new kilo lab facility. We are currently recruiting for a Process Support Coordinator to work within the expanding Drug Substance team at our Alnwick facility. You will facilitate project progression from PR&D, into drug substance manufacturing and scale up assets. Support and coordinate Drug Substance manufacturing and scale up operations to maximise throughput and meet client requirements. Advising on equipment selection and design.
The key tasks and responsibilities of the position are:
- Act as process champion, ensuring smooth transition of synthetic processes developed by the PR&D team through to GMP compliant manufacture
- Preparation of Batch Synthesis Instructions (batch records)
- Preparation of cleaning protocols, including calculation and proposal of appropriate rinse and swab limits
- Prepare EHS risk and CoSHH assessments and act as SME in Process Risk Assessments
- Preparation of Quality Risk Assessments
- Plan and manage the procurement of raw materials for upcoming manufacturing activities
- Lead technical transfer of established processes from Customer/Client facilities
- Liaise with other department(s) (i.e. QA/QC/FM) to ensure they are aware of upcoming Drug Substance manufacturing and scale-up activities
- Preparation of quality documentation, to manage unplanned deviations, changes, and corrective actions. Support of QA investigations as required
- Liaise with QC team to ensure in-process analyses are carried out in line with the production plan
- Provide technical and troubleshooting support for manufacturing operations
- Liaise with logistics and QA to organise the shipment of drug substances and intermediates
- Participation in post campaign reviews to identify opportunities for continuous improvement
- Propose and advise on equipment design, selection and acquisition, including preparing CapEx requests
- Preparation of validation documentation for new Drug Substance manufacturing equipment and facilities
- Lead on the management of calibrations (metrology) and maintenance for Drug Substance process equipment
- Assist the Head of Drug Substance Production with recruitment and induction of new hires into the Process Support function
- Operate within Environmental, Health and Safety guidelines and regulations, working with due regard to health & safety of self and others. Support EHS investigations as required
- Ensure that manufacturing and scale-up operations, and associated documentation, complies with GMP, EHS and other regulatory requirements, internal policies and procedures, and client requirements
The successful candidate will have:
- Experience of carrying out Kilo-Scale Chemistry Processing
- Degree level (or equivalent) qualification in Chemistry or a closely related discipline, with minimum of two years of relevant industrial experience.
- Awareness of the current regulatory environment
- Thorough understanding of process safety and hazards.
Other skills and experience required:
- Good written/oral communication skills
- A high level of personal integrity and commitment
- Flexible approach to new work challenges
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 business 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 & inclusions 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.