Associate Director of Analytical Service
Location : Nottingham UK | Type : Full time, permanent
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.
Reporting to the Analytical Services Director you will provide operational leadership to the Analytical services team ensuring compliance to the site pharmaceutical quality system under Good Manufacturing Practice Guidelines. You will ensure all laboratory operations and laboratory data is performed in accordance with internal procedures and in line with the site relevant licensing activities (cGMP) under MHRA and FDA regulations. You will provide analytical technical guidance to client projects and manage analytical activities to meet customer delivery expectations. You will also be expected to coach and develop your analytical team and actively support the quality culture within the company.
Main duties and responsibilities:
- Ensure compliance with the company quality systems, GMP requirements and all regulatory body requirements at all times.
- Be responsible for managing the operational aspects of the Quality Control/Analytical development team ensuring adherence to all internal Quality and Safety procedures.
- Author, review and approve documentation as necessary within the Quality Management System
- Keep up to date with current and proposed pharmaceutical regulation as applicable.
- Constantly strive to develop and support a culture of continuous improvement whereby we seek to improve quality, decrease errors and improve operational efficiency.
- Provide technical expertise and guidance for customer projects.
- Demonstrate troubleshooting capabilities across a range of analytical techniques.
- Lead / contribute to root cause analysis meetings, change controls and deviations as required.
- Represent the analytical services team in client and regulatory meetings/audits.
- Ensure customer and regulatory audits are supported as required.
- Support business development actives including review of proposals and delivery timelines in relation to analytical activities.
- Effectively manage quality projects in terms of tasks and resource. Ensure analytical costs/consumables are managed within expected budget.
- Support Upperton business growth by effectively managing resource and technical capability requirements in line with business needs.
General Role Responsibilities:
- Understand and follow the company’s Health & Safety Policy and Procedures and report all accidents or any unsafe conditions in the workplace.
- Ensure competency and compliance for training of QC/Analytical staff.
- Adhere to all HR policies and procedures, specifically including all absence policies and procedures.
- Communicate within your own department to ensure that all relevant information is forwarded to the appropriate personnel on a regular and timely basis.
Essential skills and experience:
- Significant experience of working in a Contract Development and manufacturing organisation.
- Proven experience in Investigational Medicinal Products.
- Experience of working independently and as part of a team.
- Excellent communication skills, both written and verbal.
- Excellent organisation skills with strong attention to detail.
To apply, please send a CV and covering letter to email@example.com
Closing date: 14th April 2023
If you have any questions or need some support with your application, then do not hesitate to contact us at firstname.lastname@example.org