Upperton Pharma Solutions is a Nottingham-based CDMO that specialises in the development and manufacture of pharmaceutical products, providing a complete service from early-stage feasibility to GMP clinical manufacture. Formulations cover a range of delivery routes, typically including oral (tablets & capsules), nasal and inhaled.
Continued growth and investment into the business has led to the creation of exciting new job opportunities; in our new GMP Manufacturing headquarters in Beeston, Nottingham. Upperton Pharma Solutions is undergoing a period of significant expansion to meet international customer demand and offer a comprehensive drug development portfolio, so now is a great time to join our team.
The role:
Reporting to the QC Manager the QC Senior Scientist I will be directly involved in all aspects of analytical testing. The job holder will be expected to work to cGMP and regulatory requirements and to support client projects from initial proposal to completion. They will be expected to lead analytical aspects of a project and ensure client timelines are met.
Main duties and responsibilities:
* Lead analytical aspects of a project as directed and provide analytical updates to projects during internal and external project meetings as required.
* Support and supervise analytical staff and the QC Manager in analytical project-based activities, providing leadership and technical support in laboratory activities.
* Ensure accurate completion of analytical records relating to analytical projects and quality control activities including supporting documentation such as SOPs and risk assessments.
* Contribute to writing and reviewing analytical protocols and reports as directed.
* Support the leadership team in ensuring all analytical equipment and laboratory processes are compliant to cGMP and regulatory and customer requirements.
* Support and lead activities such as LIR’s, deviations, CAPA’s, change controls.
* Overseeing client meetings involving QC data, project issues and documentation (protocols, specifications and Certificates of Analysis)
General role responsibilities:
* Understand & follow the company’s Health & Safety Policy & Procedures & report all accidents or any unsafe conditions in the workplace.
* Ensure training has been received before undertaking specific duties & that all training is recorded in training records.
* Adhere to all HR policies & procedures, specifically including all absence policies and procedures.
* Communicate within your own department and cross departmental (QA, Manufacturing, R&D) to ensure that all relevant information is forwarded to the appropriate personnel on a regular & timely basis.
* Responsible for a small number of direct reports, to provide support and guidance to them, perform 1:1s, performance reviews and objective allocations.
* Perform analytical testing as required including but not limited to HPLC, GC, KF and Dissolution.
* Review and approval of analytical data
Essential Skills and experience:
* Be educated to degree level or equivalent experience in a related scientific/technical discipline.
* Extensive 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 Office applications.
* Ability to operate in a flexible manner and handling a diverse workload.
* Positive attitude, autonomous working manner and able to work as part of a large team.
* Impeccable attention to detail, and excellent organisation, time management and a good documentation practice.
* Proficiency in chromatographic software Chromeleon.
* Understanding of safe working practices within a laboratory setting.
* GC and ELISA experience desirable.
* Experience with mentoring and training (desirable).
* Equipment validation experience (IQ, OQ, PQ)(desirable).
* Working with sterile products (desirable).
What you will get in return:
We offer employees not only a competitive salary but also an excellent suite of benefits including:
* 25 days holiday and your birthday off!
* Company contributory pension package
* Life insurance
* Private Medical Insurance through Vitality
* Internal and external training courses and professional development support
* Free onsite car parking
We know it is the little things that make every day special, so we also organise employee events for you to attend throughout the year, like our annual Christmas party, summer party and charity fund raising events.
#J-18808-Ljbffr