Scientist, Drug Product Development

GlaxoSmithKline; Upper Providence (Delaware County); On-site; USD 95,000 - 130,000; Full time

Job summary

GSK in the United States seeks a Scientist or Senior Scientist in Formulation and Process Development to advance biopharmaceutical drug product development for mAbs, bispecifics, ADCs, and related modalities.

You will perform laboratory experiments using biophysical techniques, contribute to tech transfer and scale‑up, and author development protocols and regulatory sections, collaborating with internal partners.

Qualifications

• Bachelor’s degree with 2+ years lab experience or Master’s with 1+ years in pharmaceutics or related science.
• Knowledge of protein chemistry, formulation and drug product development.
• Experience with in-use/administration compatibility studies.
• Experience using biophysical techniques for product characterization and stability.
• Regulatory documentation writing experience (IND/IMPD, BLA/MAA).
• Strong communication and teamwork skills.

Responsibilities

• Designs and executes study protocols for biopharma formulations.
• Conducts lab experiments and development studies as per protocols.
• Supports tech transfer and scale‑up for clinical manufacture.
• Authors development reports and regulatory documents.
• Maintains accurate electronic lab records and data integrity.

Skills

Drug Delivery

Laboratory Operations

Pharmaceutical Formulations

Quality by Design

Technical Writing

Education

Bachelor’s degree with related science

Master’s degree in related field

Tools

SLS

DLS

DSC

MFI

HIAC

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

Are you a scientist in sterile biopharm product formulation or process development, ready to contribute to the development of life-changing drug products? Are you eager to unite science, talent, and technology to get ahead of disease together? This may be the right opportunity for you! As a Scientist or Senior Scientist in the Formulation and Process Development department, within Drug Product Development at GSK, you will focus on developing world class patient‑centric drug products through innovation, technology and strategic partnering. The successful candidate for this position will focus on biopharmaceutical drug product development for mAbs, bispecific mAbs, ADCs, etc. The department may also provide opportunities to contribute to development of small molecule drug products, including oligonucleotides.

Role responsibilities will be focused on laboratory experimentation, with application of biophysical techniques and development stability studies to optimize protein formulations.

Role responsibilities will also include formulation robustness studies, in‑use evaluation to ensure product quality during product administration, performing process development studies (e.g., for mixing, sterile‑filtration, filling, and where applicable, lyophilization).

The role will also include contributing to tech transfer and scale‑up for clinical and commercial drug product manufacturing.

Responsibilities will include authoring of development protocols and technical reports and other related documentation, and supportive authoring of regulatory documents (e.g., sections of IND, IMPD, BLA, MAA).

Responsibilities will involve working closely with internal & external development support partners (e.g., Analytical Development, Manufacturing Sciences and Technology, etc.), maintaining accurate, complete electronic laboratory records; facile use of electronic data & information gathering, capture, archiving and communications techniques.

Key Responsibilities

• Designs and executes study protocols
• Executes a wide range of experiments and development studies independently based on a protocol
• Identifies and troubleshoots problems in the execution of experimental processes, technical studies, and tasks.
• Understands the rationale and hypotheses for experimental designs and/or has an extensive theoretical understanding of a particular area of science.
• Develops understanding of regulatory requirements
• Complies with and contributes to document content and data integrity requirements
• Authors protocols, technical reports and sections of regulatory documentation

Basic Qualification

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

• Bachelor’s degree with 2+ years of relevant laboratory‑based experience or Master’s degree with 1+ years of relevant laboratory‑based experience with the degree in Pharmaceutics, Biology, Chemistry, Biochemistry, Chemical Engineering, or related scientific discipline.
• Knowledge and/ or experience in protein chemistry/structure, protein formulation and drug delivery/device development, and drug product manufacturing (fill‑finish) and process development.
• Knowledge and/ or experience with in‑use/administration compatibility studies.
• Experience using biophysical or other techniques for product characterization and assessment of product stability (e.g., SLS, DLS, DSC, MFI, HIAC).
• Technical report writing and regulatory documentation authoring experience (IND/IMPD, BLA/MAA, etc.).
• Creative and motivated self‑starter.
• Strong organizational skills.
• Maintains accurate and complete laboratory records.
• Ability to work effectively in a team and matrix environment.
• Excellent verbal communication and technical writing skills.

Preferred Qualification

• Knowledge and/ or experience in protein chemistry/structure, protein formulation and drug delivery/device development, and drug product manufacturing (fill‑finish) and process development.
• Knowledge and/ or experience with in‑use/administration compatibility studies.
• Experience using biophysical or other techniques for product characterization and assessment of product stability (e.g., SLS, DLS, DSC, MFI, HIAC).
• Technical report writing and regulatory documentation authoring experience (IND/IMPD, BLA/MAA, etc.).

Skills

• Drug Delivery
• Laboratory Operations
• Pharmaceutical Formulations
• Quality by Design
• Technical Writing

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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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.