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Perform and manage chemical syntheses in accordance with regulatory and company procedures. Support scale up and manufacturing phases of product development including the provision of shift cover as required. In-process analysis, including sample preparation and interpretation. Use test of critical raw materials and intermediates. Participation in and preparation of HAZOP and risk assessments.
- Perform syntheses and purifications of various chemical entities within agreed timeframes. Maintain Laboratory Notebooks of Batch Synthesis Instructions, prepare Analytical Data Sheets and reports.
- Manufacture 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 tens of grams to tens of kilogram scale.
- 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.
Good knowledge and experience of synthetic chemistry covering process optimisation to ensure successful and cost-effective scale-up. Good understanding of process safety and hazard operability. Proficiency in carrying out kilo-scale chemical processing. 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.
Either a degree level (or equivalent) qualification in Chemistry or a closely related discipline or a completed apprenticeship as a chemical operator, with minimum of one year’s relevant industrial experience.
BioNH's 2019 Annual Dinner Meeting & Innovation CelebrationThe annual dinner meeting and innovation celebration will be attended by Masha Kononov, Senior Director Emerging Pharma US.
BioNH's 2019 Annual Dinner Meeting & Innovation CelebrationDates: 7th FebruaryLocation: New Brunswick, NJ
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Drug Delivery & Formulation SummitDates: 11th - 13th MarchLocation: Berlin, Germany