Team Leader/Associate Director-CMC Analytical Development

GSK LLP
Collegeville, PA, United States
9 days ago
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Role details

Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Experience level
Expert
Experience required
6 years minimum
Working hours
Regular working hours
Job source

Tech stack

Artificial Intelligence Data Analysis

Job description

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:

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  • 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.

Why You?

Basic Qualification

Requirements

  • 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

About the company

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., 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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