Scientific Leader-Associate Director- Small Molecule, Sterile Products

Are you a scientist in sterile product formulation and injectables eager to lead 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 Scientific Leader/Associate Director, you will be responsible for taking a leading role in the development of GSK’s small molecule and biopharmaceutical sterile products. You will lead international drug product development teams to define and implement formulation and development strategies to best support the future positioning of the organization.

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 NCEs/NBEs from candidate selection to product commercialization.
• Leading drug product development 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.
• Additional responsibilities may include development/optimizing protein or oligonucleotide formulations for commercialization.
• Exercise professional judgment to determine the most appropriate course of action for a project.
• Lead or contribute to Pharmaceutical 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 lead author preparing regulatory documents.
• Propose and deliver innovative approaches to achieve project goals.
• Provide correct interpretation of results and perform complex data management and analysis.
• Collaborate with representatives from project teams to undertake formal risk assessments to manage technical project risks and build a robust control strategy.
• Work across modalities to ensure seamless transfer of risk assessments activities across the product lifecycle.
• Collaborate with project teams to conduct formal root cause analyses and investigations.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• PhD in Pharmaceutics, Chemical Engineering, Biology, Chemistry, or other related fields with a minimum of 5 years of industrial experience in pharmaceutical or biopharmaceutical development.
• Experience with formulation and process development of small and large molecules particularly novel complex injectable products, e.g. long acting injectables and Oligonucleotides.

Preferred Qualifications:

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

• Experience in developing phase appropriate formulations and manufacturing processes for small molecules.
• Experience in authoring drug product modules of new drug applications, marketing authorization applications and/or Biological License Application.
• Good understanding of physico-chemical, biological properties and biopharmaceutics.
• Expertise in sterilization techniques.
• Experience in leading a product development matrix team.
• Demonstrates strong networking skills through interactions across departments, divisions, and industry.
• Familiar with cGMP and regulatory requirements for manufacturing operations and documentation.
• Good oral and written communication skills.
• 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 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 scienc