Director - Technical Development Lead

Technical Development Leader

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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 Technical Development Leader is accountable to lead the CMC development of novel vaccine technologies and vaccine candidates. The role holder will have a unique opportunity to shape delivery of the future vaccine candidates to positively impact the health of up to 2.5 billion people by the end 2030.

Key Responsibilities

• Accountable for early-stage CMC development of novel vaccine technologies and vaccine candidates.
• Establish comprehensive product technical development strategy (incl. the definition of the technical product profile) in alignment with Vaccine Development Team and Technical R&D functions.

• As leader of the cross-functional Technical Development Team (TDT), develop, coordinate, challenge and adjust technical development strategy & plans on a regular basis with key members of the TDT.
• Lead the delivery of the manufacturing process, clinical supplies and CMC sections of the regulatory files.
• Drive key CMC discussions at GSK internal governing bodies and seek endorsement of CMC strategy, plans, resources, budget, risks and timelines.
• Accountable for the assembly and quality of technical evidence to support advancement of the project across different stage gates.
• Ensure the principles of quality by design (QbD) and quality risk management are applied in the development of a robust, fit for purpose, process and product.
• Identify risks on technical feasibility, timing and resource constraints and drive appropriate remediation/mitigation.
• Be the primary contact in the context of an outsourcing partnership, as appropriate.
• Provide regular updates to management and escalate any technical/operational issues impacting project delivery.

Basic Qualifications:

• PhD in Chemistry, Biology, Chemical Engineering, Bioengineering, Biotechnology, Pharmacy or relevant discipline
• 7+ years experience in process and analytical development, scale-up and clinical/commercial development, and manufacturing in the biotechnology or pharmaceutical industry
• 5+ years experience in leading and direct management of process development, and/or manufacturing
• 5+ years experience in mRNA technology based CMC development

Preferred Qualifications:

The following characteristics would be a plus:

• Experience in vaccine development processes, knowledge of vaccine manufacturing environment and vaccine industry

• Good understanding of cGMP and FDA regulations and guidelines relating to CMC-related areas
• Excellent leadership, managerial and communications skills in a cross-functional environment
• Proficiency in analysis of scientific data and results with ability to review scientific documents including reports, publications and regulatory submissions

• Learning agility, high level of autonomy and desire to learn new things outside of one's comfort zone
• Critical mindset, pragmatic approach in problem solving
• Expertise or experience in Team/People management/Cross-functional leadership is desirable
• Spoken & written English

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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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