Scientist, Drug Product Development

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.

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  Knowledge and/ or experience in protein chemistry/structure, protein formulation and drug delivery/device development, and drug product manufacturing (fill-finish) and process development

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  Knowledge and/ or experience with in-use/administration compatibility studies

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  Experience using biophysical or other techniques for product characterization and assessment of product stability (e.g., SLS, DLS, DSC, MFI, HIAC)

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  Technical report writing and regulatory documentation authoring experience (IND/IMPD, BLA/MAA, etc.).

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  Creative and motivated self-starter

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  Strong organizational skills

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  Maintains accurate and complete laboratory records

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  Ability to work effectively in a team and matrix environment

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  Excellent verbal communication and technical writing skills

#GSK-LI

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

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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