Director, Bioassay

GSK•Upper Providence Township, PA

9d•Hybrid

About The Position

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. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Find out more: Our approach to R&D Position Summary The Extended Characterization US department within Analytical Development (AD) of Drug Development and Supply (DDS) in GSK has an exceptional opportunity for an experienced bioassay leader with in-depth knowledge of biology to join the team as Director, Bioassay. This position will lead a team of ~ 20 staff members via 6 direct reports, responsible for the end-to-end life cycle management of bioassays across modalities including development, validation, transfer to QC (Quality Control) and post-validation life cycle support.

Requirements

MSc in biological sciences (Cell Biology, Molecular Biology, Immunology or a closely related discipline) with more than 15 years of experience or PhD in the same fields with more than 10 years of experience in the biotechnology or pharmaceutical industry, focusing on bioassay development for protein therapeutics.
Hands-on experience in the development of cell-based potency assays reflective of the mechanism of action (MoA) of the products including molecules with multiple modes of MOA.
Extensive experience in the development of phase-appropriate bioassay strategies including regulatory strategies for protein therapeutics, consistent with ICH guidelines and evolving regulatory expectations.
Extensive experience 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.
Experience in overseeing GMP bioassay testing and associated quality processes/procedures such as deviation and change control.
Experience managing a team plus coaching and/or mentoring talents while embracing an inclusive and equitable environment.

Nice To Haves

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 biotechnology or pharmaceutical industry.
Experience in the development of 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.
Second line leadership (leader of leaders) experience preferred.

Responsibilities

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 (Critical Quality Attribute) identification and life cycle management, to support the development and implementation of phase appropriate analytical 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 (Good Manufacturing Practice) bioassay release and stability testing to support clinical development programs.
Contribute to quality workflows including change control, deviation and CAPA (Corrective and Preventive Action), 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 equity and inclusion principles through the process to ensure a flexible, energetic and digitally savvy workforce.