Senior Analytical Scientist

1925 GlaxoSmithKline LLC; Upper Providence (Delaware County); Presencial; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

GlaxoSmithKline plc is seeking a Senior Scientist in the Analytical Development department to design and perform experiments, develop and validate analytical methods, and support transfer across stages of pharmaceutical development.

The role involves engaging with project teams, ensuring GxP compliance, and contributing to regulatory submissions and internal reports while collaborating with cross-functional groups in a matrix environment.

Formación

• BS in Chemistry or related field with 5+ years of relevant experience.
• MS in Chemistry or related field with 3+ years of relevant experience.
• 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 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.

Conocimientos

Analytical Chemistry

Data Analysis

Regulatory Documentation

Communication

Problem-Solving

Educación

BS in Chemistry

MS in Chemistry

PhD (no industry experience)

Herramientas

HPLC

UPLC

GC

UV/Vis

KF

MS

Waters Empower CDS

Electronic Lab Notebook (ELN)

Descripción del empleo

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

• 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
• MS in Chemistry, or related scientific field with 3+ years of relevant experience
• 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

• Data Analytics Skills: SQL, PowerBI, Spotfire #GSK-LI 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

GSK is an 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.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Additional Information

For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/. We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.