Senior Synthetic ChemistDate Posted: 16/01/2020
Application Close: 28/02/2020
Location: Arcinova - Alnwick
An opportunity has arisen for a Senior Synthetic Chemist to join the Drug Substance team. This is a full-time position working within an expanding team at our Alnwick site.
An opportunity has arisen for a Senior Synthetic Chemist to join the Drug Substance team. This is a full-time position working within an expanding team at our Alnwick site. The ideal candidate should be Fully trained in handling 14C materials if radiochemist. Competent in handling scale up equipment if API development chemist. Able to plan, perform and manage chemical syntheses in accordance with regulatory and company procedures. Able to provide mentoring to more junior members of staff and advising on policy / equipment selection / standards.
The key responsibilites of the position are:
- 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.
- 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.
- 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.
- 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.
Level of independence associated with role:
- Will require intermittent guidance from Head of Department and mentoring from Team Leader.
Educational qualifications relevant to role:
- 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.
To apply please email your letter of application, CV and any relevant supporting documents to Jodie Staton.
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