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Job Title

MSAT Drug Product Lead

CLOSING DATE: 15th June 2023

GSK make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 2.3 billion packs of medicines and doses of vaccines in 2022.

We are addressing gender equality at all levels within our organisation, we also remain committed to improving ethnic diversity within GSK and recruiting and developing talent that mirrors the communities in which we work. With support from our Global Disability Council and our employee resource group, the Disability Confidence Network, we are working hard to create an inclusive workplace.

We want GSK to be somewhere everyone can feel a sense of belonging and thrive. Our success absolutely depends on our people.

The Global Manufacturing Science and Technology (MSAT) organization is a network-focused function which provides strategic direction, technical and operational support to ensure that GSK Global Supply Chain network, site goals and objectives are achieved, through a focussed strategy execution. The MSAT primary objective is to ensure manufacturing processes are capable, compliant, in control, continuously improved and aligned across Sites.

The Drug Product Lead role is responsible for the technical leadership of a given Drug Product. This role will provide leadership across multiple manufacturing sites to ensure the robust implementation of a standardised Product Control Strategy.

In this role you will…

• Responsible for ensuring all aspects of Product Quality Lifecycle Management are in place and actively maintained for drug product: Technical Risk Assessment, Product Control Strategy, Continued Process Verification and Process Robustness Assessment. Ensures risks are identified and escalated as appropriate and mitigation plans are in place and agreed within appropriate quality systems e.g. CAPAs or governance boards
• Ensures QbD principles are applied and a robust and well understood process and product control strategy are transferred during technical transfer, full scale development and commercialisation of new products from R&D, and subsequent transfers to other sites.
• Responsible for assessing the product quality impact of any change (AL1/2/3) that can impact CQAs/CPPs via review and update of Technical Risk Assessment and Product Control Strategy.
• Leads the technology transfer from R&D and then to other manufacturing sites, internally and externally
• Leads cross functional improvement projects with a clear demonstration of value created
• Provides technical input to regulatory submissions for first file, post-approval submissions, annual reports, Periodic Product Reviews, and internal and external audits.
• Responds to technical questions during regulatory submission and inspections. Recommends Technical readiness to launch, including technical aspects of Transfer Acceptance Criteria are achieved.
• Provides leadership and subject matter expertise where required to support the investigation and resolution of product complaints and deviations, in-particular complex investigations.
• Principal point of contact for all aspects of current and previous knowledge on the product and performance, including critical quality attributes (CQAs) and critical process parameters (CPPs). Accountable for maintaining this knowledge and sharing as appropriate. Provides technical leadership and establishes key relationships with the operational teams on manufacturing sites, particularly MSAT, Production, Engineering and Quality and with R&D.

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Why you?

Qualifications & Skills:

• Post graduate degree in Scientific Discipline.
• To demonstrate the appropriate level of scientific and technical understanding.
• Demonstrated experience in the Pharmaceutical or FMCG industry in leading the Technical aspects of the Product Lifecycle including Technology Transfers, Technical Risk Assessments, Product Control Strategies, Process Capability/Robustness, QbD, validation and change control
• Effectively and independently own and lead all elements of the Product Lifecycle for a specific product or product family with excellent verbal and written communication skills, and ability to influence, lead and drive change.
• Excellent dose form expertise (oral solid dose form is a must, other dose forms knowledge is desired).

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation 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’s 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’re 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).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [email protected] or 0808 234 4391. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

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