Isotope Labelling ChemistDate Posted: 31/10/2019
Application Close: 06/12/2019
Location: Arcinova - Alnwick
We are currently recruiting for a Radiosynthesis Chemist to work within an expanding team at our Alnwick site.
Summary of position
Plan, perform and manage chemical syntheses in accordance with regulatory and company procedures. Conduct route development and/or technology transfer studies in support of a range of scales from milligrams to low grams (for labelled synthesis) and grams to kilograms (for API development); taking into account scalability, safety and cost of goods for the proposed route. Support scale up and manufacturing phases including the provision of shift cover as required. Developing competencies in ICMS or API synthesis. Should be able to plan and perform synthesis in accordance with regs etc. Involvement in major projects, taking guidance from other team members. Capable of running small projects with assistance. Communication with customers primarily through more senior staff. Should be involved in the routine day to day activities which enable the department to function effectively. Capable of liasing with other departments (e.g CMC where interactions with the QC team are required). Should be able to put together cost proposals with assistance.
The key tasks of the position are:
- Plan and perform syntheses and purifications of various chemical and/or labelled chemical entities within agreed timeframes. Maintain Laboratory Notebooks, prepare Analytical Data Sheets and reports.
- Design synthetic routes. Prepare cost estimates and client proposals with assistance and in collaboration with BD liaise with clients to facilitate the award of projects to API Development.
- Capable of acting as Project Manager for small scale syntheses as assigned. Communication with customers primarily through more senior staff. Involvement in major projects, taking guidance from other team members.
- Manufacture radio and stable isotopically labelled intermediates and API at the milligram to low gram scale and synthetic intermediates and API at the tens of grams to tens of kilogram scale. Provide manufacturing shift cover as required.
- Apply the skills highlighted above to the manufacture of non-pharmaceutical materials, impurities and degradation products at the milligram to low gram scale (for labelled compounds) through to the tens of grams to tens of kilogram scale (for larger scale projects)
- 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
- Contribute to laboratory operations, equipment acquisition and maintenance, contracts, housekeeping, stock control, disposals and liaise with other departments dealing with such matters.
- Ensure, where required, that laboratory work and associated documentation complies with GMP or other regulatory requirements, internal policies/procedures and client requirements,
- Work with due regard to health &safety of self and others.
- Work flexibly across the site to meet business needs. Capable of liasing with other departments (e.g CMC where interactions with the QC team are required).
Level of independence associated with Role:
Will require training on ICMS (14C and synthesis / compliance techniques) or API (appreciation of scale up and operation of scale up equipment). Requires regular supervision from team leader and mentoring from designated team members
Key skills / educational qualifications 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.
An excellent record in Synthetic organic chemistry, either at Doctoral level or Graduate with minimum of one year’s relevant industrial experience.
To apply please email your letter of application, CV and any relevant supporting documents to Jodie Staton.
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