Science Solutions - QC Analyst - Pharmaceuticals - Hull
Science Solutions are looking to recruit an analytical chemist working in the GMP analytical team within R&D CMC (Chemistry, Manufacturing and Controls) to develop of exciting new and existing projects in the field of addiction therapy and associated co-morbidities from Phase 1 clinical trials through to commercialisation. The CMC team operates an internal and semi-virtual model.
- Provide Analytical Development support to projects within the new product pipeline supporting Hull platform technologies (solid doses and non-sterile liquids)
- Carry out analysis including stability testing, IMP release testing, method validation, process development and verification testing on new drug products, ensuring analytical aspects of drug development are effectively delivered with any issues highlighted to stakeholders in a timely manner.
- Author analytical development protocols
- Take ownership of projects assigned to you, ensuring project milestones are delivered on time and to plan.
- Actively participate in project strategy and planning meetings, risk assessments and stakeholder interactions to leverage your chemistry expertise and insight, to drive the right decisions at the right time and mitigate risk.
- Apply the principles of Quality by Design.
- Solve complex technical problems using experience, knowledge, research and advice.
- Author regulatory submissions documents
- Proactively contribute to the continuous improvement of the analytical development function with respect to new technologies and processes.
- Contribute to drug innovation by challenging current perceptions and practices.
- Train other members of the team, as required.
- A 'See it Own it Make it Happen', attitude and proven ability to take calculated risks.
- Working in a challenging, fast paced environment, on varied projects.
- Produce work of the highest quality in accordance with the relevant regulatory guidelines to challenging time scales.
- Technical problem solving and troubleshooting when required ensuring issues are addressed without delay to projects.
- The ability to think laterally in order to apply novel solutions and supporting justifications to challenging problems or situations.
- Supporting new drug development from non-clinical through all clinical phases to registration and beyond.
- A degree in chemistry (2.1 or 1st preferred)
- 1-2+ years experience in GMP analytical development
- Experience and knowledge in analytical sciences including: HPLC, GC, FTIR, Dissolution, LCMS, Karl Fischer Analysis, Agilent OpenLab (or equivalent)
- Experience within a pharmaceutical environment with a proven track record of delivering high quality work to tight deadlines.
- Results orientated, self motivated with an ability to evaluate and take risks.
- Strong analytical skills with the ability to think strategically, develop tactics and transform ideas into reality.
- Excellent communication skills and a proven ability to negotiate.
- Proven ability to work under pressure, as part of a team, without compromising quality and delivery.