Senior Synthetic Chemist
Kelly Services are keen to speak with experienced Synthetic Chemists to work for our global client based in Northumberland.
The successful candidate will be fully trained in handling 14C materials in radiochemisty. Competent in handling scale up equipment in API development. 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.
· 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 purification's 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.
We are keen to speak with candidates with 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.
On offer is an excellent compensation package along with the chance to work for a market leader in their field with an excellent company culture.
We are also offering relocation packages to assist with candidates looking to move to the area.
To express an interest in this position please apply or contact a member of the Kelly Scientific team in Newcastle.
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.