Scientific Leader/Associate Director
1 month ago
Posted Date: Aug 8 2024
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 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 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.
- Exercise professional judgment to determine the most appropriate course of action for a project.
- Lead or contribute 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 serve as 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, or other related fields with a 5+ years of industrial experience in pharmaceutical development.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- Extensive expertise in the formulation and process development of peptides and oligonucleotides.
- Significant industry experience in late-stage combination drug product development and commercial technical transfer.
- Demonstrated experience in authoring drug product modules of NDA/BLA applications for global markets.
- Experience in developing phase appropriate formulations and manufacturing processes for small molecules.
- Excellent oral communication and technical writing skills.
- Good knowledge of QbD as presented in regulatory dossiers.
- Experience with technical risk assessments (FMEA) and control strategy development.
- Experience in leading a product development matrix team.
#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.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at US Toll Free) or outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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