Job Description

Site Name: UK - Hertfordshire - Ware, Jurong
Posted Date: Jun 1 2023
Molecule Steward The role may be based in Ware, UK but can be based at other global strategic locations on a case-by-case basis. This is a truly exciting opportunity for an experienced scientific professional to take end-to-end technical accountability for a given product, from bulk API manufacturing, formulation, packing and related support activities, providing strategic Technical leadership to ensure successful new product introduction, quality robustness and productivity improvements across the lifecycle. The Molecule Steward is aligned to a new asset at Commit to Commercial Development with responsibility for representing MSAT in the development of the Product Control Strategy. When the product transfers to GSC accountability, the Molecule Steward co-ordinates Drug Substance, Drug Product, Analytical Strategy and if appropriate Device Leads to maintain the Product Control Strategy and ensure the product is maintained in the desired state of control throughout product lifecycle. You will be responsible for developing and delivering the technical elements of the Medicine Lifecycle Supply Strategy with the MSCL and will be the recognised expert in the given product or dose form, in addition to providing strategic technical leadership. Ready to shape the future of healthcare? In this role you will be:

• Representing MSAT as technical single-point accountable decision maker to CMC Matrix and Medicine Supply Chain teams, ensuring that a product control strategy is defined and maintained to drive a robust product that meets target manufacturability criteria.
• Responsible for defining the End-to-End Product Performance Qualification and Ongoing Continuous Verification Strategy for the product, including trending and sampling plans and ensuring alignment and consistency across supply nodes.
• Maintaining accountability for the product, from transfer from R&D throughout its lifecycle, ensuring improvement plans (including 2nd generation processes) are developed and delivered impacting the manufacturing process, analytical process, pack, device, and associated specifications to deliver value.
• Maintaining solid knowledge and understanding of complex scientific subject matter as well as evolving regulatory policies and guidelines and industry best practices. This knowledge is used in developing improvement plans for the product.
• Accountable from an MSAT perspective for defining technology strategy & specific solutions as required to support the overall product or dose form lifecycle.
• Responsible for leading Product Technical Review Teams, ensuring risks are identified and mitigated and technical issues are resolved in a timely manner.
• Responsible for co-ordinating the review of regulatory submissions and responses to technical questions within MSAT, ensuring review by appropriate SMEs and sites.
• Providing leadership and subject matter expertise where required for investigations and/or critical deviations, troubleshooting, and major change programmes.
• Ensuring that product history and knowledge from development through lifecycle is maintained and aligns with knowledge management standards for the product or dose form within the GSC network.
• Managing strong collaborations with technical staff across the Supply Chain sites, MSAT & R&D, with effective and clear communication on highly technical topics. Must be able to lead and operate in an environment with high degree of change and uncertainty.

CLOSING DATE for applications: 15th June 2023 Please take a copy of the advert, as this will not be available post closure of the advert. 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. Why you? Required qualifications and skills:

• University Degree (minimum) in Chemistry, Chemical engineering, Pharmaceutical Sciences or similar area
• Comprehensive knowledge of external regulatory requirements (MHRA, FDA), and internal/external quality and safety requirements
• Experienced in technology transfer, with an understanding of the product development process
• Knowledge of current and emerging Regulatory Strategies (Quality by Design, GMP for 21st century, ICH Q7, Q8, Q9, Q10) and Product Lifecycle Management
• Demonstrated experience in the pharmaceutical industry in leading the technical aspects of Product Lifecycle Management, including supporting process investigations.

Preferred qualifications and skills:

• Project management and prioritization skills gained within a complex matrix
• Excellent problem solver and ability to think and work creatively
• Strong technical acumen and communication skills with the ability to articulate complex, technical details to stakeholders and enable cross functional collaboration across sites, supply chain, R&D and suppliers
• Experience managing external partners/CDMO\xe2\x80\x99s in NPI and/or commercial supply
• Ability to effectively influence stakeholders at all levels

We 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 1.7 billion packs of medicine and 767 vaccine doses in 2021. We continue to modernise, so we can launch even more new products at speed whilst turbo-charging delivery across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in technology and products will be revolutionary. Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of automation and robotics so we can work smarter together. Find out more: Annual Report 2021 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 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\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). 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 Ukdiversity.recruitment@gsk.com 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. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK\'s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK\xe2\x80\x99s compliance to all federal and state US Transparency requirements. For more information, please visit GSK\xe2\x80\x99s Transparency Reporting For the Record site.