Senior Process Development Chemist

Senior Process Development Chemist

Company Overview

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.

The Role

An opportunity has arisen for a Senior Process Development Chemist to join the Drug Substance and Isotope Labelling team. This is a permanent position reporting to one of the Drug Substance Team Leaders.

Main tasks and responsibilities: 

• Acting as Project Manager for major projects as assigned with a minimum of managerial oversight. Accountable for managing project deliverables and budget. Ensure that awarded work is progressed and reported to the expected quality standards/schedule.
• Project manages own projects with a minimum of managerial oversight. Accountable for managing project deliverables and budget. Provides customer updates independently.
• Design synthetic routes. Prepare cost estimates and client proposals without assistance and in collaboration with BD liaise with clients to facilitate the award of projects to the department.
• Plan and perform syntheses and purifications of various chemical and/or labelled chemical entities within agreed timeframes. Apply isotope chemistry knowledge if radiochemist to the development of products that meet expected target product profile, taking into account scalability, safety and cost of goods for the proposed route.
• Maintain Laboratory Notebook, ensuring that this is countersigned, and contribute to countersigning others’ books as assigned.
• Ensure, where required, that laboratory work and associated documentation complies with GMP or other regulatory requirements, internal policies/procedures, and client requirements.
• Apply the skills highlighted above to the manufacture of non-pharmaceutical materials, impurities, and degradation products at the milligram to low gram scale through to the tens of grams / tens of kilogram scale (for larger scale projects).
• Provide shift cover as required, for scale up and manufacturing phases.
• Perform in-process analytical testing where relevant and/or ensure that analytical, microbiological (where relevant) and materials science/spectroscopic testing needs are discussed and agreed with the CMC team.
• Prepare data packages on such chemical entities so that the identity of same should be considered conclusively proven. Provide written reports to clients as necessary. Archive data after completion of project.
• Contribute to laboratory operations, equipment acquisition and maintenance, contracts, housekeeping, stock control, disposals and liaise with other departments dealing with such matters.
• Assist in the selection of equipment and, with Facilities, prepare CAPEX justifications for purchase of equipment as required.
• Responsibility for GMP & non-GMP laboratory management, including housekeeping and equipment maintenance. Point of contact for Audits, FM and Contractors.
• Assist in the selection of equipment and, with Facilities, prepare CAPEX justifications for purchase of equipment as required.
• Work with due regard to health &safety of self and others.
• Participate in and produce process risk assessments for process to be scaled up on site.
• Produce, review, and approve GMP compliant Batch Synthesis Instructions and other process documentation.
• Prepare and review validation protocols for new GMP equipment.
• Contribute to the completion of Dossiers by providing scientific and process knowledge.
• Apply QbD principles for the development of processes for commercial API manufacture. 
• Work flexibly across the site to meet business needs.

The Candidate

The successful candidate will have an excellent record in Synthetic organic chemistry, either at Doctoral level with considerable postdoctoral industrial experience or Graduate with extensive industrial experience.

Other skills and experience required:

• Knowledge and experience of synthetic chemistry covering route selection.
• Full awareness of the current regulatory environment, a comprehensive understanding of process analytical chemistry, impurity control and/or sufficient analytical skills to conduct in-process testing and a good understanding of the factors controlling API physical form.
• Good written and oral communication skills. 

Company benefits:

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.