Team Leader/Associate Director-CMC Analytical Development

GSK; Collegeville (PA); On-site; USD 110,000 - 170,000; Full time

Job summary

GSK is seeking a senior analytical leader to guide a small team delivering method development and lifecycle management for small molecules in drug discovery and development.

You will partner across functions and with external labs, driving clear technical strategy, regulatory documentation, and continuous improvement to impact patients and progress programs.

Qualifications

• Relevant degree in chemistry or related field with lab leadership experience.
• 6+ years (for Ph.D.) or 8+ years (for M.S.) or 10+ years (for B.S.) in analytical development or leadership in pharma.
• Experience supporting CMC activities and regulatory submissions.

Responsibilities

• Lead and coach a team to deliver analytical method development, validation, and lifecycle management across multiple projects.
• Own technical strategy for assigned projects and coordinate execution with internal and external partners.
• Design and oversee 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

Data Analysis

Method Development

Cross-functional teamwork

Leadership

Regulatory Submissions

Education

Ph.D. in Chemistry

M.S. in Chemistry

B.S. in Chemistry

Tools

HPLC

UHPLC

GC

QbD

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.

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

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• 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

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• 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

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

• 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.

#GSK-LI

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.

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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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