CMC Leader

Are you energized by a highly visible leadership role that allows you to deliver our innovative portfolio of biopharmaceutical assets?  If so, this CMC Development and Industrialization Leader role is an exciting move to explore!

As a Biopharmaceutical CMC Leader, you will lead delivery of the CMC development, supply, and regulatory plans with a high performing matrix team to deliver innovative medicines to patients. This role requires the knowledge, courage, and credibility to lead a high performing multi-disciplinary matrix team of CMC and supply chain experts to develop and deliver the manufacturing process, supply chain, physical medicinal product, and regulatory submissions to enable clinical trials, regulatory approval, and a secure commercial supply of a medicine.

This is a critical leadership position in GSK, leading across R&D and Global Supply Chain (GSC), defining, and delivering the global CMC strategy and plans for a new medicine. The successful candidate will join the Large Molecule Medicine Development & Industrialization team, leading significant biopharm medicines and driving cross-portfolio improvements.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

Lead CMC development and industrialization of a medicine:

• Lead the definition and delivery of global CMC strategy and plan for a key medicine, aligning with global medicine strategy, patient needs, commercial intent, overall business context and regulatory, compliance and manufacturing network requirements.
• Provide options for CMC delivery to align with the project objectives, with recommendations on implications (risks, costs, resources and time) for the global lifecycle of the medicine.

Leads the CMC matrix team:

• Lead cross-functional multi-disciplinary CMC matrix team (~10 core and ~50 extended members) to develop and deliver CMC project plans to time, budget and resource forecasts.
• Own the performance of the CMC matrix team: partner with line managers to appropriately resource the project with the right expertise, and to develop and support the core and extended team members to drive performance and deliver the project.

Be the Voice of CMC for the project:

• Influence medicine development and commercialization plans and appropriate investment in CMC activities, and to the functional lines to ensure capability and capacity to deliver.
• Provide CMC input to due diligence reviews of business development proposals, including opportunities and risks in the context of the proposed medicine and business strategy.

Provide Enterprise leadership of product portfolio and CMC Operating Model:

• Understand cross-portfolio CMC performance, identify and drive strategic improvements.
• Align senior leaders across R&D and GSC on strategic CMC plans and risk mitigation activities and the investments and resources required to deliver.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor of Science in a relevant science or engineering discipline
• 10+ years’ experience in biopharm CMC development, manufacture, supply and regulations
• 2+ years’ line and/or matrix leadership experience of multi-disciplinary global teams
• Director level experience working with both internal and external partners and senior leaders

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• MS/MBA or PhD/EngD with director level leadership experience in the development or manufacture of biopharmaceuticals
• Strong communicator, decision maker, agile learner, masterful manager of conflict
• Able to analyze complex situations to provide innovative solutions and clear direction
• Able to influence at very senior levels in the business and across multiple disciplines
• Collaborative, inclusive and transparent, builds and cultivates high performing partnerships
• Strong knowledge of biopharm development, manufacturing, supply chain, and quality
• Knowledge of E2E non-clinical, clinical, regulatory and commercial aspects of development

#LI-GSK

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

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 billion