Opening For Pharmaceutical Development Project Manager - Yorkshire

1 post / 0 new
Amar Annamalai
Amar Annamalai's picture
Opening For Pharmaceutical Development Project Manager - Yorkshire

 • Project Manager – Pharmaceutical IMP Development
• Leading Pharmaceutical company in Leeds, Yorkshire
• Up to £32,000 + Benefits
• Brand new position within fast-paced R&D department
• Knowledge of liquid dose pharmaceutical product development ESSENTIAL
 
Summary
 
A prestigious opportunity for a commercially-focused Pharmaceutical Project Manager who understands drug formulation and development (especially for liquid oral dosage forms). This is a brand new role within an R&D department of 30 people, performing a range of project-based activities to supply IMPs for clinical studies, optimise product stability of clinical drugs, ensure compliance to GCP regulations, support the introduction and validation of new equipment and ensure that IMPs are shipped correctly (including to strict temperature protocols).
 
The Company
 
A specialist Pharmaceutical organisation with a pioneering approach to creating alternative dosage forms for patients who have specific requirements. The company has an excellent reputation for its ongoing training and development, staff morale and buzzing atmosphere. If you are looking for a broad challenge that includes technical and interpersonal skills, this is definitely the place to work.
 
The Role
 
This is a very broad role that incorporates a range of activities across the R&D department. The company has a healthy development pipeline, which means large and small scale clinical studies, complex regulatory submissions and frequent audits.
 
As a Project Manager, you will undertake a number of ongoing concurrent projects across the clinical trial supply chain. For all projects, you will devise a Gantt chart and will use this to monitor the progress of different project activities. You will co-ordinate the supply of IMPs to clinical studies, collate information for the completion of Trial Master Files and ensure that different cross-functional teams work in close collaboration to ensure smooth-running of IMP supply projects. Your other duties will include:
 
• Hold project meetings as part of overall project plans 
• Responsibility of implementing specific projects and support the introduction & validation of new equipment
• Take responsibility for facilitating technical batches
• Prepare weekly plans from the schedule requirements, measure & report output against plan. 
• Co-ordinate obtaining Clinical trial reference and test material, arrange for retains to be taken and stability if required
• Arrange for necessary documentation for a T-Licence if applicable and other requests from the CRO (through US clinical team)
• Coordinate testing of IMP with QC and QA including non-routine tests such as syringe hold
• Collate all documentation for the trial as it becomes available into the Trial master File and correspondence files.
• Checking and monitoring of temperatures of materials shipped.
• Coordinate shipping of the IMP with respect to any import export licenses, purchase orders.
• Manage IMP returns, reconciliation and disposal
• Work alongside the Reg Affairs team for archiving over trial documentation
 
Requirements
 
The successful candidate will ideally have a scientific degree, together with proven experience in the development of liquid dosage forms. Knowledge of the clinical trial supply process would be highly advantageous, as would an understanding of QC / QA / regulatory affairs processes. Ideally you will have some kind of project management-related qualification (e.g. PRINCE2), though this is not essential if you can demonstrate a decent knowledge of project management tools (e.g. Gantt charts and the ability to collaborate with key internal stakeholders).
 
Keywords
 
Project Manager, GSA, GMP, GCP, QC, QA, IMP, CTS, clinical trial supply chain, investigational medicinal product
 
This is a permanent role
To apply for this role please contact Steve Twinley on 01403 216216 or email your CV and covering letter to: pharma.jobs@sls-services.co.uk