Quotient Sciences Acquires Arcinova

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Senior Synthetic Chemist

Date Posted: 27/05/2021
Application Close: 04/06/2021
Location: Arcinova - Alnwick

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


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Job Description

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

 

Key Tasks: 

 

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.

 

Education:

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.

 

Experience:

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.  

 

Our commitment to Diversity & Inclusion

Arcinova, a 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.

 


To apply please email your letter of application, CV and any relevant supporting documents to Kate Emanuel.

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