Senior Analytical Scientist

GSK; Collegeville (PA); Presencial; USD 110 000 - 170 000; Tempo integral

Resumo da oferta

GSK in Collegeville, PA seeks a Senior Scientist in Analytical Development to design, validate, and transfer analytical methods for drug substance and drug products. You will collaborate with project teams across development stages to establish robust analytical strategies.

You will lead assay development, ensure GxP-compliant documentation, review protocols and data, and contribute to regulatory filings. Strong knowledge of HPLC/UPLC, spectroscopy, and data analytics is essential.

Qualificações

• BS in Chemistry or related field with 5+ years of experience; MS with 3+ years; PhD with no industry experience.
• Experience with method development and validation, pharmacopeia compliance and analytical lifecycle management.
• Technical expertise with several analytical techniques and laboratory procedures.
• Experience interpreting and communicating experimental data.

Responsabilidades

• Develop and perform assays that support development, release and stability testing of drug substance and drug products.
• Document laboratory work in accordance with GxP expectations, company policy, and legal requirements.
• Review experiments, stability protocols and other key documentation.
• Contribute to patents or regulatory submissions and internal reports.
• Identify and troubleshoot problems in experimental processes; interpret results and communicate to supervisor.
• Provide scientific input and recommendations to the project team for analytical control strategies and influence decision making.

Conhecimentos

Analytical Chemistry

Analytical Instrumentation

Data Analysis Tools

Laboratory Methods

Communication Skills

Formação académica

Bachelor's in Chemistry

Master's in Chemistry

PhD in Chemistry

Ferramentas

HPLC

UPLC

Waters Empower

Electronic Lab Notebook

GxP Knowledge

Descrição da oferta de emprego

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

As a Senior Scientist in the Analytical Development department, you will design and perform experiments to develop, validate and transfer various analytical methods. You will be involved in all aspects of pharmaceutical development, including engagement with project teams and other stakeholders for projects in different stages of development.

Responsibilities

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

• Develop and perform assays that support development, release and stability testing of pharmaceutical drug substance and drug products.
• Documents laboratory work in accordance with GxP expectations, company policy, and legal requirements.
• Review of experiments, stability protocols and other key documentation.
• Contribute to sections of patents or regulatory submissions as well as internal reports.
• Identifies and troubleshoots any problems in the execution of experimental processes; interprets results and communicates them to his/her supervisor.
• Provides scientific input and recommendations to the project team for analytical control strategies and influence decision making.

Basic Qualification

• BS in Chemistry, or related scientific field with 5+ years of relevant experience, or MS in Chemistry, or related scientific field with 3+ years of relevant experience, or PhD with no industry experience.
• Experience with method development & validation, pharmacopeia compliance and analytical lifecycle management.
• Technical expertise and working familiarity with several analytical techniques, and laboratory procedures.
• Experience with interpreting and communicating experimental data.

Preferred Qualification

• Knowledge of cGMP requirements
• Experience with analytical support of small molecule API and ADC drug linker intermediate development.
• Awareness with FDA/EU/UK and ICH regulations and guidances related to analytical transfer and validation and release and stability testing.
• Working knowledge and experience in small molecule analytical techniques such as HPLC, UPLC, GC, UV/Vis spectrophotometry, KF, MS, and laboratory procedures.
• Experience working with CRO's/CDMO's.
• Good technical writing skills for documentation and experience in regulatory documentation authoring.
• Ability to collaborate and communicate well with others in and across groups in a matrix environment.
• Thorough operational knowledge of laboratory equipment and laboratory systems (e.g. Waters Empower CDS and Electronic Notebook system).
• Data Analytics Skills: SQL, PowerBI, Spotfire

Skills

Analytical Chemistry, Analytical Instrumentation, Analytical Laboratory, Analytical Thinking, Bioprocessing, Data Analysis Tools, Electronic Lab Notebook (ELN), Gas Chromatography (GC), High-Performance Liquid Chromatography (HPLC), Laboratory Reports, Method Development, Technical Problem-Solving, Ultra Performance Liquid Chromatography (UPLC), Ultraviolet Visible Spectroscopy, Waters Empower

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.

Equal Opportunity Employer

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.