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Reference #: 392449 Site Name: Upper Providence Posted Date: Mar 25 2024

Are you energized by an R&D leadership role that allows you to shape scientific strategy and advance the development of key medicines? If so, this role could be an ideal opportunity to explore.

The Structure and Function Characterization (SFC) department within Analytical Development (AD) of Medicine Development Supply (MDS) in GSK has an exceptional opportunity for an experienced bioassay leader with in-depth biology knowledge to join the team  In this newly-created opportunity, the Director Bioassay, will lead a team responsible for the lifecycle management for bioassays across modalities including development, validation, transfer to QC and post-validation life cycle support.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

Work with internal or external discovery partners to design and develop cell-based potency assays, reflective of the mechanism of actions of the product, including selection of relevant cellular models, detection techniques and statistically justified experiment layout.

Develop phase-appropriate cell-based potency assay strategies to support non-clinical and clinical development, as well as commercial and life cycle management.

Lead or contribute to CQA identification and life cycle management, to support the development and implementation of phase appropriate control strategies.

Engage internal and external stakeholders/partners in the development of method transfer strategies and execution of method transfer for the release and stability testing for clinical and commercial drug substances and drug products.

Lead the identification, evaluation and implementation of new technologies applicable to bioassay development including assay reagents preparation, streamlining assay procedures and automation.

Promote and support digitization and data modernization, to ensure streamlined use of data for critical decision-making and improving efficiencies.

Manage GMP bioassay release and stability testing to support clinical development programs.

Contribute to quality workflows including change control, deviation and CAPA, ensuring that the team is compliant with quality and safety regulations and GSK policies.

Lead or support the identification and partnership management of external partners (e.g. CROs) related to bioassay development and/or routine sample testing under both GMP and non-GMP environment.

Contributed to regulatory submissions and interactions related to bioassay and analytical strategies in general.

Manage operation and capital budget for the team and proactively work with leadership team on resource forecasts and management.

Recruit, train, retain and develop talents, embedding DEI principle through the process, to ensure a flexible, energetic and digitally savvy workforce.

Why you?

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

BSc / MSc in biological sciences (Cell Biology, Molecular Biology, Immunology or a closely related discipline) with more than 20 years of experience or PhD in the same fields with more than 15 years of experience in the biotech industry, focusing on bioassay development for protein therapeutics.

Experience in MoAs and their impacts on the development of protein therapeutics including antibody therapeutics.

Extensive experience in the development of phase-appropriate bioassay strategies including regulatory strategies for protein therapeutics.

Extensive expertise in the development, validation, transfer and life cycle management of bioassays to support protein therapeutics from candidate selection through clinical development and post-approval support.  Expert in relevant ICH guidelines and regulatory expectations on bioassay and analytical strategies in general.

Experience in overseei g GMP bioassay testing and associated quality processes/procedures.

Experience managing a large team including leading team leaders with a diverse groups of team members.

Experience in coaching and/or mentoring talents while embracing of DEI principles.

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

Experience in the development of oligonucleotide therapeutic, in particular developing functional assays for oligonucleotides would be highly desirable.

Experience and/or familiarity with other biological methods (e.g. qPCR, SPR and ELISA) for the characterization of protein therapeutics would be a plus.

Experience working across Discovery, non-clinical, clinical and CMC functions on understanding MOA and structure function relationship of therapeutic candidates would be of added value.

#LI-GSK Why GSK?

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

Why Us? 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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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