Posted Date: Sep 26 2022
Are you interested in providing world class technical expertise and oversight to internal manufacturing operations? If so, the Molecule Steward position might be for you!
The Molecule Steward role is the single point of end-to-end technical accountability for a given product, from bulk API manufacturing, formulation, filling, assembling, packing and related support activities, providing strategic technical leadership to ensure successful new product introduction, quality robustness and productivity improvements across the lifecycle.
You will be 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 through product lifecycle.
As the Molecule Steward, you will be the recognized expert in the given product or dose form and in addition to strategic technical leadership, you will be expected to provide deep technical expertise where required to ensure highest levels of quality and robustness.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Representing MSAT, providing a single point accountable decision maker MDIT or MSCT, ensuring that a product control strategy is defined and maintained to drive a robust product that meets manufacturability criteria.
- 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.
- Staying current and maintaining solid knowledge and understanding of complex scientific subject matter as well as evolving regulatory policies and guidelines and industry best practices.
- Being accountable from an MSAT perspective for defining technology strategy & specific solutions as required to support the overall product or dose form lifecycle.
- Leading PTRT’s ensuring risks are identified and mitigated and technical issues are resolved in a timely manner.
- Co-ordinating the review of regulatory submissions and responses to technical questions across MSAT, ensuring review by appropriate SME’s and sites.
- Providing leadership and subject matter expertise where required for investigations and/or critical deviations, troubleshooting, and major change programs.
- 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.
We are looking for professionals with these required skills to achieve our goals:
- BS, Scientific discipline
- Ph.D. 10+ years’ experience, MSc 12+ years’ experience, BSc 15+ years’ experience in a scientific discipline
- Experience and practical experience managing technical piece of end-to-end pharmaceutical drug product life cycle.
- Experienced in technology transfer in a Pharmaceutical environment.
- Understanding of and experience successfully navigating regulatory and quality landscape.
- Experience developing and managing strong collaborations with technical staff across the Supply Chain sites, MSAT & R&D, with effective and clear communication on highly technical topics.
If you have the following characteristics, it would be a plus:
- PhD/MSc in scientific discipline
- Experience leading and operating in an environment with high degree of change and uncertainty.
- Large molecule product life cycle experience preferred.
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk
- Managing individual and team performance.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Implementing change initiatives and leading change.
- Sustaining energy and well-being, building resilience in teams.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Developing people and building a talent pipeline.
- Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
- Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
- Budgeting and forecasting, commercial and financial acumen.
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 impact the health of 2.5 billion people around the world in the next 10 years.
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.
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