Scientist/Principal Scientist - Bioassay Development, Validation and Tech Transfer

The Analytical Department within the Medicine Development and Supply organization has an exciting opportunity for an enthusiastic and driven Scientist/Principal Scientist to join our Bioassay team. This lab-based position offers an exceptional opportunity to contribute to the development, validation, and tech transfer of cell-based potency methods, which are vital to drug development and manufacturing processes. By joining our team, you will play a key role in delivering new medicines to patients while advancing your career in the biopharmaceutical industry.

Key Responsibilities:

• Develop and validate cell-based bioassays used for characterization, comparability, and GMP release and stability samples analysis
• Participate in early/late-phase validation and method transfer activities to commercial testing laboratories
• Provide scientific input on method development with a focus on MOA (Mechanism of Action) functional mechanisms
• Demonstrate a strong understanding and experience in GMP (Good Manufacturing Practice)
• Collaborate with biology SMEs (Subject Matter Experts) to establish cell-based methods suitable for GMP settings

• Ensure laboratory compliance with regulatory standards, data integrity, safety and quality standards consistent with company policies
• Identify and address compliance issues in experiments and lab protocols
• Independently conduct and manage experiments with increasing complexity
• Design, execute and accurately record experimental data
• Identify and troubleshoot problems during experiments, proposing solutions based on data and contributing to process improvements
• Collaborate with data science and automation teams
• Foster and maintain good relationships both within and outside of Analytical Development department

Why you?

Basic Qualifications:

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

• Ph.D. or Master's degree with 2+ years of experience, or Bachelor's degree with 5+ of experience in performing or developing cell-based potency methods in an academic institution, biotechnology, or pharmaceutical industry

• Cell biology experience with cell-based method development and troubleshooting
• Experienced in cell-culture techniques, including culturing various immortalized adherent and suspension cell lines

Preferred Qualifications:

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

• Experience with cell-based methods for oligonucleotide and ADC (antibody-drug conjugate) therapeutics

• Experience with liquid handling automation instrument for performing cell-based assays (e.g. Hamilton, HP D300e)

• Experience working in a GMP compliant laboratory
• Maintaining and validating GMP compliant instruments
• Experience with Digital, Data and Analytics tools (e.g. Spotfire, PowerBI)
• Ability to independently conduct and manage experiments, as well as analyze and interpret data
• Excellent communication and strong technical writing skills for documentation

#LI-GSK

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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