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

GSK; Collegeville (PA); On-site; USD 120,000 - 180,000; Full time

Job summary

GSK in Collegeville, PA seeks a Scientist/Sr. Scientist for bioassay development, validation and tech transfer. You will develop and validate cell-based assays, support MOA-based method development, and collaborate with GMP teams to transfer methods to external labs.

The candidate will work with biology SMEs, data science and automation teams to ensure high-quality data, scalability and regulatory compliance, contributing to drug development.

Qualifications

• Ph.D. or Master’s 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

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 to establish cell-based methods suitable for GMP settings
• Ensure laboratory compliance with regulatory standards, data integrity, safety and quality standards
• 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

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

Education

Ph.D. in Biology or related field

Master's degree in Biology or related field with 2+ years experience

Bachelor’s degree with 5+ years cell-based potency methods experience

Tools

Flow cytometry / FACS

Liquid handling automation (Hamilton, Tecan, HP D300e)

Spotfire

PowerBI

Job description

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.

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)

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.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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