Scientist - Drug Product Development

Site Name: USA - Pennsylvania - Upper Providence
Posted Date: Feb 23 2023

Are you seeking an opportunity where you can grow your technical expertise on pharmaceutical analysis and development? If so, this Scientist role could be an exciting opportunity to explore.

As a drug product development scientist, you will develop sterile drug products for protein and peptide-based therapeutics. The candidate will execute a wide range of experiments and development studies independently based on a protocol. This role includes identifying and troubleshooting problems in the execution of experimental processes, technical studies, and tasks.

This role will provide YOU the opportunity to contribute to CMC development of early phase drug products from pre-clinical through Phase 1 clinical studies and to progress YOUR career.

Your responsibilities include the following:

• Responsibilities will be focused on laboratory experimentation, analytical testing, and drug product manufacturing of putative formulations & drug delivery approaches for select protein therapeutics.
• This includes contributing to conception & evaluation of conventional & novel product formulations, administration modalities, and manufacturing processes;
• Physicochemical and bioanalytical characterization and testing of biopharm compounds
• Working with the Analytical Development group to define analytical method target profile for monitoring quality attributes for use in product development, release and stability testing
• Crafting & execution of non-GMP stability studies to generate product and drug product manufacturing process knowledge, and interfacing with our partner organizations to craft GMP stability protocols and assess resultant data
• Working closely with internal & external discovery and development support partners, as needed; maintaining accurate, complete laboratory records
• The role also requires verbal and written communication with excellent organization skills, as well as broader scientific knowledge.
• Both individual and team working are essential and therefore the role will suit a scientist with strong interpersonal skills, good abilities in data analytics and bioinformatics, and high self-motivation.
• Authoring and review of SOPs, technical reports, and regulatory documentation (e.g., IND/IMPD).
• Complying with data integrity requirements

Why you?

Basic Qualifications:

• A Bachelor’s degree with 2+ years of laboratory-based experience, or Master’s degree in Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related scientific discipline
• Experience with protein or peptide chemistry, formulation and drug delivery/device development, and drug product manufacturing

Why you?

Preferred Qualifications:

• Experience with both conventional and alternative protein formulation and drug delivery/device approaches or experience in protein drug product manufacturing process area.
• Ability to generate data, independently collate, analyze, interpret and draw conclusions from the data

• Experience using bioanalytical and/or biophysical techniques for critically assessing product characterization and product stability evaluation, including e.g., HPLC, capillary electrophoresis, SEC, and Spectroscopy (UV/VIS, fluorescence, or CD).
• A strong understanding or working knowledge of Differential Scanning Calorimetry/Fluorimetry and Viscometry, sub-visible particulate imaging
• Experience in regulatory documentation authoring (IND/IMPD, BLA/MAA, etc.).
• Ability to collaborate well with others in and across groups in matrix

Why GSK?

GSK is 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.

#LI-GSK

#CMCDevelopmentGSK

GSK is 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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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