Msat External Manufacturing Lead
4 weeks ago
**Site Name**: USA - Pennsylvania - King of Prussia, UK - Hertfordshire - Ware, USA - Maryland - Rockville
**Posted Date**: Jun 30 2023
Are you energized by an opportunity to lead a technical team, in support of our highly innovative large molecule portfolio, and through a broader network of CMOs? If so, this MSAT External Manufacturing leadership role could be an exciting opportunity to explore.
In this role, you will be responsible for leading a highly technical team of large molecule leaders. Through them, you will ensure that the technical teams are delivering to the needs of the product, and either strategic change, improvement of issue resolution objectives, and working closely with the broader procurement, quality, and supply teams and with a large group of CMOs. This role will also work closely with the large molecule external manufacturing leadership team, ensuring strategic and operational alignment.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
- Building and maintaining a highly capable team, focused on externally manufactured large molecule products, and operating effectively across the external network of strategic CMOs, thereby delivering and responding to the needs of the business.
- Providing mentoring and coaching to the team, to remove obstacles, provide experience, or make connections to the broader MSAT organization to ensure we deliver to the needs of the business.
- Driving successful technical transfer, including knowledge, clinical & PPQ batches, and the aligned process characterization and validation and regulatory submission authoring and readiness. Driving performance through these to deliver to key performance indicators, and continuously looking for ways to improve and leverage best practice.
- Ensuring that robust product lifecycle management principles are deployed across the products, CMOs and broader supply based and are continuously reviewed and improved.
- Defining and deploying technical standards, training materials and competency frameworks, and delivering them effectively to the teams.
- Defining and deploying new technologies across the products, CMOs and broader supply base, and in alignment to the respective platform strategy.
- Providing technical expertise and input to external strategic change initiatives and activities.
- Liaising effectively with all the aligned technical groups, ensuring that experts from across global supply chain and the broader enterprise are engaged and working effectively to support the needs of the business.
- Representing MSAT in the large molecule external manufacturing leadership team, and inputting on the aligned strategies, plans and improvement programs.
- Providing input on large molecule sourcing decisions, working closely with procurement, quality & supply to ensure that the right CMO and sites are selected.
**_ Why you?_**:
**Basic Qualifications**:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor’s degree in a scientific discipline.
- Technical knowledge and 8+ years’ experience in large molecule products and dose forms.
- Knowledge of control strategies, and quality by design (QBD).
- Knowledge of regulatory requirements including FDA, EMA, PMDA.
- Knowledge of quality and safety requirements.
- Experience leading teams across MSAT & external supply chains.
**Preferred Qualifications**:
If you have the following characteristics, it would be a plus:
- PhD in scientific discipline.
- Knowledge of key unit operations of cell culture, purification, formulation, fill finish and analytical methods.
- Experience driving project lifecycle transfer and change and complicated decision making.
- Experience interacting with CMO leadership teams, across broad networks, and building effective relationships.
- An ability to set departmental objectives, development plans and to grow capabilities, and drive decisions around product and program lifecycle changes.
- An independent, strong management style, with confidence - to be able to partner and challenge external CMOs on behalf of the business.
**_ Why GSK?_**:
- 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
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