Reference #: 397587 Site Name: USA - Pennsylvania - Upper Providence Posted Date: Jun 6 2024

. 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 Drug Product Development - Steriles department 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 protein (e.g., mAbs, bispecific mAbs, ADCs).  This role will include application of protein formulation and development stability assessment, in-use compatibility/stability assessments to support product administration, and drug product process development, characterization, and technical transfer activities. The department also provides 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 (non-GMP) stability studies to optimize protein formulation (including in-use evaluation to ensure product quality during product administration). Responsibilities will also include authoring of development protocols and technical reports and other related documentation, and supportive authoring of regulatory documents (e.g., IND, IMPD, BLA, MAA). Responsibilities also include 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 include: 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 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 technical reports and sections of regulatory documentation

Why you? Basic Qualifications: We are looking for professionals with these requirements to achieve our goals: Bachelor's or Master's degree in Pharmaceutics, Biology, Chemistry, Biochemistry, Chemical Engineering, or related scientific discipline For BS degree, 4 years of laboratory-based experience; For MS degree 2 years of laboratory-based experience

Preferred Qualifications: Knowledge and/ or competencies in protein chemistry/structure, protein formulation and drug delivery/device development, and drug product manufacturing (fill-finish) and process development 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 Some experience in small molecule (including oligonucleotides) drug product development is also considered a plus, since as a whole, the hiring department develops both large molecule and small molecule assets #LI-GSK Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits p ogram 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 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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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.

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