GSK is building capabilities in particle characterization to support our innovation pipeline and growing portfolio of drug products. Particle characterization is an essential component of the filing and control strategy for many next generation drug products. As a member of our Particle Size Characterization and Analysis team, you will be responsible for the development, validation, and technology transfer of robust analysis methods enabling the development and delivery of innovative medicines.
The environment is highly technical and dynamic requiring collaborations across disciplines to provide holistic understanding of the relationship between particle size distributions, crystallinity and other particle and matrix properties impacting immediate release products, and/or long-acting injectable suspensions and solutions. You will thrive in this environment if you are able to effectively prioritize and manage multiple tasks, communicate analytical results and your recommendations clearly, and if you are a team player who is ambitious for patients, accountable for impact, and prioritize doing the right thing.
Why you? Basic Qualifications:
- Support particle size control strategy development by designing and conducting laboratory studies for understanding of the structure, surface and bulk properties of an active pharmaceutical ingredient (API) to its performance downstream to inform decision making as well as drug product linking material properties to preclinical and clinical performance
- Develop robust particles size analytical methods to ensure quality assurance and regulatory success, and support method transfer from R&D to QC laboratories.
- Collaborate and communicate effectively in matrix team environment of multi-disciplinary experts comprising of Process Chemists, Analytical Scientists, Particle Development and Formation Engineers, Modelers, Formulators and Material Scientists.
- Comply with cGMP and Safety regulations and GSK policies for data integrity and documentation management. Support for qualification and maintenance of analytical instruments to comply with cGMP standards.
We are looking for professionals with these required skills to achieve our goals:
- Experience demonstrating technical knowledge in particle size characterization, method development, validation, and transfer in a GMP environment
- B.S. in Analytical Chemistry, Chemical Engineering, Materials Science or related discipline with a minimum of 5 years of pharmaceutical development
If you have the following characteristics, it would be a plus:
- Experience and expertise with particle size characterization techniques, and other solid-state characterization techniques spanning from colloids to bulk powders.
- Understanding of the impact of sample preparation and analysis technique on apparent particle properties.
- Understand surface and interfacial phenomena and how this can impact particle analysis and product performance.
- Experience and expertise with the physical characterization of long acting injectables
- Experience in particle size analysis for regulatory purposes.
- Ph.D. in Analytical Chemistry, Chemical Engineering, Materials Science or related discipline.
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 is ambitious for patients
- so we deliver what matters better and faster; accountable for impact
- with clear ownership ofgoals and support to succeed; and where 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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