Are you a Leader in sterile formulation and injectables eager 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!
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.
- 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 Product Development &Supply technical matrix team and wider matrix teams.
- Exercise professional judgment to determine the most appropriate course of action for a project.
- Leads or contributes 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 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.
PhD in Pharmaceutics, Chemical Engineering, or other related fields with a minimum of 5 yrs. of industrial experience in pharmaceutical development.Preferred Qualifications:
- Experience in formulation and process development of small molecules, particularly novel complex injectable products, e.g. long acting injectables, liposomes, etc.
- Experience in formulation and process development of oligonucleotide drug products 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 and marketing authorization applications is preferred.
- 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.
- Experience in leading a product development matrix team is preferred.
- Demonstrates strong networking skills through interactions across departments, divisions, and disciplines
- Familiar with cGMP and regulatory requirements for manufacturing operations and documentation.
- Good oral and written communication skills.
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges we've made to our business in over 20 years.We're on track to separate and create two new companies in 2022:
New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and geneticsscience; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culturethat isambitious for patients
- so we deliver what matters better and faster;accountable for impact
- with clear ownership ofgoals and support to succeed; andwhere we do the right thing
. So, if you're ready to improve the lives of billions, join us at thisexciting moment in our journey. Join our challenge to get Ahead Together.
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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.
At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.
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