Senior Process Development Chemist
Senior Process Development Chemist
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.
An opportunity has arisen for a Senior Process Development Chemist to join our Drug Substance department. The individual will be competent in handling scale up equipment with the ability to plan, perform and manage chemical syntheses in accordance with regulatory and company procedures. Able to provide mentoring and supervision to more junior members of staff and advise on department policy, equipment selection, standards.
- Deputise for the Team Leader as required
- Capable of 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.
- Independently provide customer updates
- 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 entities within agreed timeframes. Apply chemical knowledge to ensure that target molecules meet expected target product profile, taking into account scalability, safety and cost of goods for the proposed route.
- Maintain a laboratory notebook, ensuring that this is countersigned, and contribute to countersigning others’ books.
- 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. Archiving of data
- Contribute to laboratory operations, equipment acquisition and maintenance, contracts, housekeeping, stock control, disposals and liaise with other departments dealing with such matters.
- 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.
- 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 drug substance manufacture.
The successful candidate will have excellent 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 drug substance physical form. Good written and oral communication skills.
Other skills and experience required:
An excellent record in Synthetic organic chemistry, either at Doctoral level with minimum four years postdoctoral industrial experience or Graduate with minimum of six year’s relevant industrial experience.
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.