The Manufacturing Science and Technology (MSAT) function provides best in class processes that ensure the products and inputs are understood and maintained through the product life-cycle within the wider manufacturing and production operations at the GSK Ware PSC (Pharma Supply Chain) Site. This entails all elements of the manufacture, testing and supply process from launch through to planned changes and to transfers.
Job Purpose:
Reporting to the Micronising and Respiratory MSAT Director you will manage a team of platform leads and technologists to ensure the Product Control Strategy is translated into manufacturing and monitored for the Micronising, Blending and Filling unit operations. Managing the delivery of complex technical change and improvement programmes to processes, products and equipment technologies to meet business demands.
Key Responsibilities (include..,):
Developing / managing a highly competent team of platform leads and technologists to successfully discharge the project, risk, change and knowledge management responsibilities associated with supporting Ellipta (respiratory) Micronising, Blending and Filling unit operations.
Provide efficient, effective and compliant technical support to the Product Stream manufacturing processes. This extends to actively facilitating the improvement of process capability and batch yields across the dose form (specifically, be accountable for Cost of Goods (CoGs) and Cost of Waste (CoW) improvement).
Responsible for acquiring, developing and maintaining process and product knowledge expertise, and knowledge management of unit operations, specifically ensuring that product control strategies are understood, clearly translated into operational documents.
Ensure MSAT are appropriately represented in production investigations. providing technical leadership into complex technical issues ensuring they are investigated fully to root cause and CAPA are agreed and implemented to agreed timelines to prevent reoccurrence. This includes promoting and monitoring technical standards throughout the product stream and ensure they are adhered to.
Responsible for ensuring appropriate systems to track, trend and analyse process performance are in place to deliver key technical activities (including NPI trials and planned change implementation).
In-depth knowledge of cGMP and Global Regulatory requirements and ensure that GMP, Quality, Health and Safety processes are adhered to by all reports.
Fixed Term Contract (FTC) \xe2\x80\x93 The Fixed Term Contract is expected to last circa 1-year in duration.
About You:
This role would suit a self-motivated individual who has experience of working in a cross-functional, highly-regulated manufacturing and supply organization. You will be resilient and calm under pressure, with strong people-management skills and a proven ability to influence people to achieve objectives and drive performance. You will actively seek and act upon feedback and have a strong continuous improvement mindset. You will be degree qualified in a suitable Scientific or Engineering discipline (or have strong relevant experience). There is an expectation in this role to maintain learning agility, with the capacity to rapidly develop understanding of Innovative technologies, new manufacturing processes, control systems and Production ways of working. we are looking to see that applicants have a clear understanding of the complexities and importance of supporting production within a pharmaceutical manufacturing process.
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\xe2\x80\x99s 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.
CLOSING DATE for applications: Friday 12th of January 2024 (COB).
Basic Qualifications and experience:
BSc in Scientific or Engineering discipline or equivalent experience
Operational knowledge and understanding of manufacturing processes associated with dosage form
Knowledge of external regulatory requirements (MHRA, FDA), and internal/external Quality and safety requirements
Preferred skills / experience:
Knowledge of GPS and value stream ways of working
Track record of improving products, processes and trouble-shooting
Knowledge of process validation, scale-up and technology transfer
Good knowledge of internal and external quality and EHS requirements
Experienced in managing technical teams to deliver results
Project management skills and experience on major technical projects
Why Us?
GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it\xe2\x80\x99s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We\xe2\x80\x99re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).
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