Team Leader/Associate Director-CMC Analytical Development

GlaxoSmithKline; Upper Providence (Delaware County); On-site; USD 120,000 - 150,000; Full time

Job summary

GSK in the United States is seeking a senior Analytical Scientist to lead a small team delivering high-quality analytical solutions for drug discovery and development. You will design method development, validation, and transfer activities, partnering with internal teams and external labs to ensure regulatory-ready data.

The role emphasizes practical leadership, collaboration, and delivering measurable impact for patients, with opportunities to grow, influence projects, and advance science and

Qualifications

• Relevant degree in chemistry, biochemistry, analytical science, or related field.
• 6+ years (for Ph.D.) or 8+ years (for MS) or 10+ years (for BS) or equivalent experience in analytical development or laboratory leadership in the pharmaceutical industry.
• Experience supporting CMC activities and contributing to regulatory submissions.
• Experience with chromatographic and other separation techniques (e.g., HPLC, UHPLC) and common detectors.
• Experience in analytical method development, qualification or validation, and method transfer.
• Experience working with cross-functional teams and external partners.
• Experience with GMP as it relates to analytical/QC labs.
• Prior people leadership, mentoring, or matrix team leadership experience.

Responsibilities

• Lead and coach a team to deliver analytical method development, validation, and lifecycle management across multiple projects, primarily for small molecule DS/DP.
• Own technical strategy for assigned projects and coordinate execution with internal and external partners.
• Design and oversee execution studies for product and process characterization and control strategy definition, stability testing, and release.
• Oversee method transfer, troubleshooting, and technical readiness for GMP testing.
• Author and review scientific documentation to support regulatory filings and quality systems.
• Mentor colleagues, promote a safe laboratory culture, and support continuous improvement.

Skills

Analytical Chemistry

Analytical Instrumentation

Analytical Laboratory

Automation Technology

Data Analysis Tools

Method Development

Technical Problem-Solving

Matrix Leadership

Education

PhD in Chemistry

Tools

HPLC/UHPLC

Job description

Business Introduction

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

You will lead a small team of analytical scientists to deliver high-quality analytical solutions that support drug discovery and development. You will partner across functions and with external labs to design and execute method development, characterization, and transfer activities. We value a practical scientific thinker who leads with clarity, supports career growth in others, and focuses on delivering measurable impact for patients. This role offers growth, visible influence on projects, and the chance to unite science, technology and talent to get ahead of disease together.

Responsibilities

• Lead and coach a team to deliver analytical method development, validation, and lifecycle management across multiple projects, primarily for small molecule DS/DP.
• Own technical strategy for assigned projects and coordinate execution with internal and external partners.
• Design and oversee execution studies for product and process characterization and control strategy definition, stability testing, and release.
• Oversee method transfer, troubleshooting, and technical readiness for GMP testing
• Author and review scientific documentation to support regulatory filings and quality systems.
• Mentor colleagues, promote a safe laboratory culture, and support continuous improvement.

Basic Qualification

• Relevant degree in chemistry, biochemistry, analytical science, or related field.
• 6+ years (for Ph.D.) or 8+ years (for M.S.) or 10+ years (for B.S.) or equivalent experience in analytical development or laboratory leadership in the pharmaceutical industry.
• Experience supporting CMC activities and contributing to regulatory submissions
• Experience with chromatographic and other separation techniques (for example HPLC, UHPLC) and common detectors.
• Experience in analytical method development, qualification or validation, and method transfer.
• Experience working with cross-functional teams and external partners.
• Experience with GMP as it relates to analytical/QC labs
• Prior people leadership, mentoring, or matrix team leadership experience.

Preferred Qualification

• Advanced degree (MS or PhD) in a relevant scientific discipline.
• Experience with a variety of modalities (small molecule, ADCs, antibodies, etc.), and exposure to all stages of drug development
• Experience directly managing employees
• Experience with lifecycle management and process characterization principles.
• Experience implementing new digital/AI tolls to improve efficiency
• Strong written and verbal communication skills and experience preparing technical documentation.

Skills

• Analytical Chemistry
• Analytical Instrumentation
• Analytical Laboratory
• Analytical Thinking
• Automation Technology
• Bioprocessing
• Chemical Processes
• Data Analysis Tools
• Dosage Forms
• Drug Development
• Matrix Leadership
• Method Development
• Technical Problem-Solving

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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at [e-mail].

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.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit https://openpaymentsdata.cms.gov/.