Scientist/Sr. Scientist - Bioassay Development, Validation and Tech Transfer

Scientist/Sr. Scientist – Bioassay Development, Validation and Tech Transfer
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
The Extended Characterization group of the Analytical Development Department within the Drug Development and Supply organization has an exciting opportunity for an enthusiastic and driven Scientist/Senior Scientist to join our Bioassay team. This lab-based position offers an exceptional opportunity to contribute to the development, automation, 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,
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
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
Basic Qualifications:
Ph.D. or Master’s degree in Biology, Biological Science or Molecular Biology 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
Two or more years experience in cell biology experience with cell-based method development and troubleshooting
Two or more years of experience in cell-culture techniques, including culturing various immortalized adherent and suspension cell lines
Preferred Qualifications:
Understanding and experience in GLP (Good Laboratory Practice) or GMP (Good Manufacturing Practice)
Experience with cell-based methods for Biologics, oligonucleotide and ADC (antibody-drug conjugate) therapeutics
Ability to independently conduct and manage experiments, as well as analyze and interpret data
Excellent communication and strong technical writing skills for documentation
Experience with liquid handling automation instrument for performing sample preparations and/or cell-based assays (e.g. Hamilton, Tecan, HP D300e) is a plus
Experience with cell line creation by gene transfection techniques
Experience with Flowcytometry/FACS will be a plus
Maintaining and validating GMP compliant instruments
Experience with Digital, Data and Analytics tools (e.g. Spotfire, PowerBI)
#LI-GSK
Skills
Biopharmaceuticals, Bioprocessing, Cell Line Development, Drug Development, Experimental Methods, Molecular Cell Biology, Pharmaceutical Industry, Pharmaceutical Manufacturing, Quality by Design, Regulatory Submissions, Simulation Models, Technical Writing, Technology Transfer
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 purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
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