Director - Critical Reagent

We are seeking a highly motivated, flexible, and experienced scientific leader with demonstrated expertise in reagent generation and characterization. This individual will be responsible for leading the Critical Reagent group responsible for ensuring the timely and efficient management of Critical Reagents used in the development, validation, and execution of bioanalytical, immunogenicity and biomarker assays to support clinical development. The successful candidate will work closely with bioanalytical, immunogenicity and biomarker assay groups and cross-functional teams in GSK to identify, generate, select, and qualify Critical Reagents, as well as their monitoring, tracking, and storage. The role is based in our R&D hub at Upper Providence US.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following...

• Serve as the head of Critical Reagent group, managing a team of 4-5 lab scientists.
• Have ownership of Critical Reagent strategy for all bioanalysis, immunogenicity and biomarker endpoints (ADA, Nab, Biomarker and PK) internally and externally.
• Be responsible for the generation, characterization, labeling, shipping, inventory management of Critical Reagents.
• Build and maintain relationships with external reagent vendors for activities such as anti-idiotype antibody generation campaigns.
• Assist assay trouble shooting through reagent characterization.
• Be responsible for the continuous improvement of the Critical Reagent infrastructure including technology platforms (SRP, Octet, ATKA, HPLC, DLS and LC/MS platforms) and processes.
• Recruit and train staff for Critical Reagent support.
• Drive Critical Reagent in vs out strategy.
• Work closely with other functional lines within GSK to source reagents for bioanalytical and biomarker assays and to drive company-wide reagent strategy such as evaluating non-animal alternatives for antibody production.
• Interface with discovery for biopharm portfolio awareness to ensure timely reagent generation for clinical support.
• Represent GSK at industry consortiums on bioanalysis Critical Reagents. Monitor trends/advancements and implement best practices. Enhance external reputation of the group. Influence industry practice and regulatory opinions on Critical Reagents for bioanalysis.

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

• Ph.D. in a scientific field, such as biochemistry, biophysics, chemistry, or biology with 5+ years of experience in protein sciences, analytical, or bioanalytical sciences. M.S. with at least 10 years of industry experience will be considered as well.
• Experience with the Biophysical Characterization of Biologics, such as SPR/Octet, Octet, AKTA, SEC/HPLC, DLS and LC/MS.
• Experience with Critical Reagent sourcing, screening, qualification, and management principles, as well as current industry best practices and regulatory requirements.
• Experience in protein labeling (e.g. biotin, ruthenium and fluorescent labels), purification, and characterization of Critical Reagents (e.g. peptides, protein, antibodies, and antibody fragments).

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

• Excellent communication skills - will need to interface between many functional areas to achieve shared goals.
• Excellent attention to details, excellent organizational skills, and proven ability to manage multiple projects simultaneously and prioritize tasks in a fast-paced environment.
• Knowledge in developing methods to support validation of biopharmaceutical PK, biomarker and/or immunogenicity assays.
• Experience of direct line management.

#LI-GSK
Please visit GSK US Benefits Summary 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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