Process Analytical Technology (PAT) Manager
BSc in Scientific or Engineering discipline or equivalent experience
- Comprehensive knowledge of external regulatory requirements (MHRA, FDA), and internal/external quality and safety requirements
- Operational knowledge and understanding of manufacturing processes associated with a dosage form.
- Experience working in a cGMP aligned pharmaceutical environment.
The NPI (New Product Introduction) and Technical function provides best in class processes that ensure all product inputs are understood and maintained through the product life-cycle within the wider manufacturing and production operations at the GSK Ware GMS (Global Manufacturing and Supply) Site. This entails all elements of the manufacture, testing and supply process from launch through to planned changes and to transfers.
Following re-organisation within NPI & Technical department this new role has been created to ensure the site meets its ambition for application of Process Analytical Technology (PAT) for the Continuous Tableting Line and other manufacturing processes. Reporting directly to the Technical Director for OSD (Oral Solid Dose), you will take responsibility for leading a team of up to 6 Process Analytical Technology Engineers to implement PAT to the continuous tableting line (and other manufacturing processes) in line with the NPI development plans and lifecycle management of PAT for commercial products. You will be responsible for developing and delivering the PAT strategy for the Ware site, which will include providing technical leadership to ensure the PAT applications are world-class and aligned to the site's commercial objectives. Your team will also take responsibility for the technical transfer of the PAT methods (including the equipment, method, model and data infrastructure requirements) from R&D to the Ware GMS site. You and your team will continue to work closely with R&D to ensure alignment between GMS and the R&D function for current and future PAT applications.
As this role is multi-faceted and includes liaising with on-site production and operations teams, as well as working closely with GSK's Research and Development functions, you will be a self-motivated individual who has experience of working in a complex manufacturing site. Ideally, you will have experience of the application of PAT for pharmaceutical products with strong line-management and people skills. A proven ability to drive performance is a must. It is imperative in this role that you demonstrate an ability to drive common-objective thinking, with a complete focus on providing solutions. You will be resilient and calm under pressure, with strong people skills and a proven ability to influence people to achieve objectives and drive performance. You will need to be persuasive, have a strong continuous improvement mindset, and have proven experience dealing with diverse internal and external stakeholder groups. Ideally you will have worked in a highly regulated-industry.
During the application process we are looking to see that applicants have a clear understanding of the complexities and importance of supporting production within a pharmaceutical manufacturing process.
GSK is a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. Our products are used by millions of people around the world, helping them to do more, feel better and live longer. Employing over 100,000 people globally, we have 71 manufacturing sites around the world. For more information on GSK please refer to our website: www.gsk.com
About Ware Manufacturing Site:
Medicines at Ware are presented as either Respiratory devices or in Oral Solid Dose form. The site holds a unique position in our network as the only site responsible for launching the company's pipeline of new medicines in these dose forms, many of which are life saving medicines. A series of investments in new state-of-the-art equipment are being made that will support the delivery of a record number of new products. This must be achieved whilst consistently delivering outstanding quality, service and value to our patients.
Applicants must demonstrate in their application how they meet the above criteria in order to be successful for interview selection.
CLOSING DATE for applications: Monday 21st August (Mid-Day) 2017.
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process.
If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
You may apply for this position online by selecting the Apply now button.
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