Director, Head of CMC Early Development and In-Process Analytics, US

Director, Head of CMC Early Development and In-Process Analytics US

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At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease.

We believe the Greater Boston area is an important hub for the biotech and pharma industry, which is why we've invested in growing our footprint and expanding our R&D space in Cambridge, with a primary focus on additional state-of-the-art lab space. Here, we will bring together talent and expertise, building upon GSK's long history of vaccine development, to create globally leading viral capabilities and cutting-edge vaccines technologies, as we add to our robust portfolio targeting infectious diseases at every stage of life.

The CMC Early Development and In-Process Analytics US is a new team that will combine three strategically important groups acting in synergy to successfully transform a vaccine idea into a product:

• The Mammalian Expression Technologies Center of Excellence (MET CoE) focuses on developing high-producing cell lines for CHO recombinant protein-based vaccines and advancing next-generation cell line engineering (genome editing, precision genetic engineering) for innovative vaccine strategies. This team is currently based in Rockville, MD.

• The Nucleic Acid Vaccines Center of Excellence (NAV CoE) develops cutting-edge mRNA Drug Substance vaccine platforms for rapid development of new vaccine candidates. Its mission is also to onboard alternative nucleic acid modalities and platforms to shape next generation vaccine technologies. It has branches in Rockville, MD (to be moved to Cambridge, MA in Q2 2025) and in Rixensart, Belgium.

• A new In-Process Analytical team (IPA) will support the two Centers of Excellence by developing fit-for-purpose analytical tools to accelerate pre-Ph1 development and mRNA platform development.

We are seeking a Director to lead the CMC Early Development and In-Process Analytics group, to be based in Cambridge, MA. This senior leader will be responsible for establishing the team at its new Cambridge location, transferring current labs and team members from Rockville, recruiting top-tier scientists, and building a high-performing team to advance vaccine candidates from discovery and pre-clinical phases through the CMC roadmap. Additionally, the Head of CMC ED&IPA will drive the development of innovative, next generation technologies in the fields of RNA and cell line development technologies to maintain GSK's leading position in the industry.

The leader of this combined team should be knowledgeable in analytical development, molecular biology, expression system development, and mRNA technologies. The leader is also expected to engage the teams to work as an agile and liquid organization and adapt to a complex and changing environment.

This role will report to the Head of Global Drug Substance (based in Belgium) and will play a significant role in shaping current and next-generation GSK vaccine platforms (CHO and mRNA) to address unmet medical needs, directly impacting patients and global health. This exciting opportunity allows you to lead key activities, collaborate with top talents in the vaccines industry, and advance your career while ensuring timely project delivery in collaboration with process development colleagues and GMP teams.

Key Responsibilities:

• Build, lead and Integrate a High-Performing Team: onboard, manage, coach, and develop this newly formed team of top leaders and managers, strengthen their role in early vaccine development, and drive their integration into the Global Drug Substance team.

• Strategic planning and collaboration: design and drive the scientific strategy of both Centers of Excellence and IPA and integrate it into the end-to-end CMC strategy. Establish and maintain strong collaboration and interaction both locally and globally with internal (DS, TRD) and external (Discovery, Preclinical, GSC, Quality, Regulatory etc.) partners.

• Act as a key opinion leader: think and act strategically, impact and influence within DS, across functions and at senior leadership level to continuously improve and shape the CMC strategy and framework.

• Innovation: implement innovative approaches in a timely and strategic way, continually auditing and adapting the skills and knowledge of the team, but also ensuring that the relevant stakeholders are onboard.

• Serve as a member of the global Drug Substance leadership team, contributing to strategic planning and collaboration across the TRD network (Including Italy, Belgium and US sites).

• Cultivate department culture: maintain excellence in science and operations, embracing an open global mindset, fostering a positive culture of transparency and collaboration within the global organization.

The candidate is also expected to spend few months (from 3 to 6 months) within the first year in Rockville (Washington DC area) to support and ensure a smooth transition of the methods and the knowhow to the new laboratories in Cambridge.

Basic Qualifications:

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

• PhD with degree in Molecular Biology, Biotechnology, Bioengineering, Chemical Engineering or a related scientific field

• 5+ years' experience as leader of a scientific team in biologics or vaccines Drug Substance development

Preferred Qualifications:

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

• Industry experience in genome engineering and development of mammalian cell lines for recombinant protein expression, mRNA / nucleic acid technologies and analytical development

• End-to-end vision of vaccines product and process development

• Knowledge of regulatory vaccine landscape FDA/ICH/ISPE

• Effective scientific and people leadership

• Demonstrated critical and strategic thinking

• Excellent communication skills, with capability to influence senior leaders and lead in complex dynamic environments

• Proficiency in project management

• Open, can-do and positive mindset is a must

• Fast decision making and adaptability.

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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 billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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