Investigator/Principal Investigator– Injectable Products (Formulation Scientist)

Job description

Nombre del sítio: USA - Pennsylvania - Upper Providence
Fecha de publicación: Jan 12 2024

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

This 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 Product 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

Preferred Qualifications:

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

·  2+ yrs of industrial experience in pharmaceutical drug product development.
·  Experience in formulation and process development of small molecules, particularly novel complex injectable products, e.g. long acting injectables, liposomes, etc.
·  Experience in developing phase appropriate formulations and manufacturing processes for small molecules.
·  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

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

Why Us?

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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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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