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Investigator or Principal Investigator, Injectable Products

4 months ago

Collegeville, Pennsylvania, United States GlaxoSmithKline Full time
Site Name: USA - Pennsylvania - Upper Providence
Posted Date: Jul 8 2024

Are you looking for your next opportunity in formulation and process development?

The Investigator or Principal Investigator, Injectable Products role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
  • Member of a team responsible for enabling the progression of NCE's from candidate selection to product commercialization.
  • Lead drug product development matrix teams and/or member of matrix teams supporting product development.
  • Progress drug product design & development aspects of projects, utilizing experience and expertise as part of a Medicine Development &Supply technical matrix team and wider matrix teams.
  • Exercise professional judgment to determine the most appropriate course of action for a project.
  • Contributes to Drug Product Development strategies.
  • Develop phase appropriate formulations to support clinical studies and ultimately commercialization.
  • Develop and optimize processes for the manufacture of drug products and participate in manufacturing of clinical supplies.
  • Design and execute DOE, scale up studies, and participate in technology transfer.
  • Prepare development reports and participate in preparing regulatory documents.
  • Propose and deliver innovative approaches to achieve project goals.
  • Provide correct interpretation of results and perform complex data management and analysis.


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • PhD in Pharmaceutics, Chemical Engineering, or other related science fields
  • 0 to 2 or more years of industry experience in pharmaceutical drug product development.
  • Experience in developing phase appropriate formulations and manufacturing processes for small and large molecules.


Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Experience in formulation and process development of small and large molecules, particularly novel complex injectable products, e.g. long acting injectables, liposomes, LNP etc.

• Good understanding of physico-chemical properties and biopharmaceutics is desired.

• Expertise in sterilization techniques is preferred.

• Experience in working within a product development matrix team.

• Demonstrates networking skills through interactions across departments, divisions, and disciplines

• Familiar with cGMP and regulatory requirements for manufacturing operations and documentation.

• Experience with technical risk assessments (FMEA) and control strategy development.

• Good knowledge of QbD as presented in regulatory dossiers

• Experience conducting root cause analyses and investigations

#LI-GSK

Please visit GSK US Benefits Summary t o 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 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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