Upperton Pharma Solutions is a Nottingham-based CDMO that specialises in the formulation and spray drying of pharmaceutical and biotechnology products, providing a complete service from early-stage feasibility through to development and scale-up (including GMP clinical manufacture). Formulations cover a range of delivery routes, typically including oral (tablets & capsules), nasal and inhaled.
The Upperton laboratories and manufacturing plant are situated on the Science Park, adjacent to the University of Nottingham, and since obtaining an MHRA clinical trials manufacturing licence in 2019 we have experienced rapid, continuous growth across the whole business to continually satisfy our growing, international customer base.
As part of this expansion programme Upperton is looking to recruit a Senior Analytical Co-ordinator to join our Analytical Team.
The Role:
We are looking for someone with previous pharmaceutical industry experience working within a GMP laboratory. The job holder will be responsible for the verification of laboratory data, along with the co-ordination of writing and checking of project documentation within QC to meet both internal and external project deadlines. They will also assist in the anticipation and scheduling of future testing and subsequent data review.
The candidate will have a good working knowledge of and experience within a GMP laboratory environment with particular focus on HPLC. Knowledge of experimental documentation and operations of a QC-GMP laboratory is essential. This is primarily a data review/co-ordinator role however the candidate may be expected to perform analytical testing on occasion to meet business needs. Strong IT skills is essential, as well as being reliable, enthusiastic, self-motivated with excellent written and verbal communication skills. Flexibility in working hours may be required on occasion to meet business/project needs.
Key Responsibilities:
- Ensure that work performed by the analytical team is compliant with applicable procedures and related analytical methods. Verifying all respective raw data including electronic data, notebooks, logbooks, and worksheets.
- Mentor and discuss with scientists when necessary for all required corrections, training them where appropriate to improve their good documentation practise.
- Assistance in the scheduling and planning of QC daily testing, data review and reporting to clients.
- Assist in procurement and supplies of laboratory reagents and consumables for the QC team.
- Assistance in the writing and investigation of deviations and laboratory investigations.
- Generation and implementation of CAPAs and change controls.
- Assist with the preparation and review of Quality Control documentation including analytical reports, certificates of analysis, stability reports and specifications.
- Due to our future expansion, there is always a fresh challenge, offering you the chance to develop both your expertise and the analytical team itself.
Essential Criteria:
To satisfy the demands of this exciting yet challenging role we are looking to recruit a highly motivated individual who has the following skills and experience necessary to perform the role:
- Be educated to degree level or equivalent experience in a related scientific/technical discipline.
- Minimum of 5 years’ experience in industry within a GxP laboratory environment, with practical experience of pharmaceutical analysis using HPLC and/or UPLC methods.
- Experience working to, and a strong understanding of GMP, GLP, and ICH guidelines.
- Have excellent communication skills (written and verbal), and proficiency in the use of Microsoft 365 applications.
- Knowledge and understanding of laboratory investigations and quality deviations.
- Ability to operate in a flexible manner and handle a diverse workload.
- Impeccable attention to detail, and excellent organisation, time management and good documentation practice.
- Proficiency in chromatographic software such as Chromeleon and OpenLAB.
- Understanding of safe working practices within a laboratory setting.
- Working knowledge of multiple laboratory techniques such as dissolution and water content. GC and ELISA experience desirable.
To apply please send a CV to Helen Gisby, Director of Analytical Services Careers@Upperton.com
Closing date for applications: Friday 10th February 2023 – No agencies please