In the coming years, the modality of molecules in GSKs pipeline combined with the likely accelerated nature of the approval pathways is potentiating a significant growth mode in the need for flexible resources, new technologies, varied capabilities, and increased capacities that are not currently available within GSK's current internal infrastructure. This growth mode is bifunctional in nature spanning both small and large molecules as well as development and commercial operations. To that end, GSK has established the Strategic External Development (SED) and External Manufacturing (EM) organizations to harness the ambition. The intent of these organizations is to build and expand a platform of strategic external partnerships that provide the necessary growth flexibility required to deliver GSK's building portfolio of products including Oncology, Immuno-inflammation, HBV and HIV.
The Strategic External Development (SED) team is an empowered, innovative, and agile CMC development organization that will unlock the potential to rapidly deliver an increased number of transformative medicines to patients through exceptional relationships with trusted global partners.
The candidate will be responsible for building strong and trusted relationships with GSK Strategic External partners and supporting our large molecule portfolio. This role is essential for ensuring that the relationships are managed effectively, and risks escalated, across the governance framework including interactions with the senior leaders of the suppliers to ensure the relationships deliver value to GSK long-term.
This position establishes and enforces necessary governance needed to minimize the risk across the portfolio of projects/activities executed at the Strategic Supplier for GSK. Within each relationship both the appropriate quality, safety and technical (scientific and engineering) processes and systems must be in place to ensure delivery to GSK and external standards. This position is also accountable for driving continuous improvement to ensure GSK is getting the most value from the spend with these suppliers
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following…Key Responsibilities
Why you? Basic Qualifications:
- Direct and lead the establishment, maintenance, growth, and governance of strategic relationships with external contract development and manufacturing organizations (CDMOs) focusing on biologics.
- Act as the primary external interface with partners who are delivering services globally and across pharmaceutical development and clinical supply, with a scope spanning non-regulated through to GxP services to support the R&D portfolio and ultimate commercialization.
- Ensure appropriate monitoring of safety, quality, technical capabilities, and performance at Strategic partners in pharmaceutical development and clinical supply and drive continuous process improvement between GSK and Strategic Suppliers.
- Work with key stakeholders within the GSK organization to ensure the internal organization is educated and aware of critical efforts, timelines, risks and other key information in a timely manner.
- Meets regularly with internal GSK Stakeholders to ensure broad CMC strategies are aligned and review recent results, set next plans, and assure appropriate progress is being made on assigned partnerships.
- Simplify the current interactions with external partners across multiple business units who need to interact with or assure the activities in the suppliers' facilities both before and during work,
- Fosters a team culture of ownership and accountability.
We are looking for professionals with these required skills to achieve our goals:
- BS/MS degree minimum of 10+ years of relevant experience, which includes experience as a pharmaceutical functional area scientist; or PhD with minimum of 8+ years of relevant experience.
- Experience leading CMC / pharmaceutical development projects
- Experience with external partnerships in the biopharma space and/or vendor management.
- Experience with large molecules and/or biologics
- Travel (some domestic and international) will be required.
If you have the following characteristics, it would be a plus:
Why GSK? Uniting science, talent, and technology to get ahead of disease together
- Proven leadership and cross-functional management of large-molecule Biologic CMC projects.
- Ability to translate complex concepts into actionable and measurable tasks.
- Excellent people management skills with the ability to develop effective relationships, motivate others and influence in a cross-functional environment.
- Exhibits high initiative, strong drive, and follow-through.
- Requires flexible work schedule to accommodate program priorities and international activities.
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we're making the most significant changes we've made to our business in over 20 years.We're on track to separate and create two new companies in 2022:
New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that isambitious for patients
- so we deliver what matters better and faster;accountable for impact
- with clear ownership of goals and support to succeed; andwhere we do the right thing
. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. *This is a job description to aide in the job posting, but does not include all job evaluation details.
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