Are you energized by a challenging role in biology, where scientific demand is driving team growth? If so, this Scientist role would be a great opportunity to consider.
The Nucleic Acids Vaccines Center of Excellence team (Technical Research & Development, GSK Vaccines) is seeking an enthusiastic, experienced and motivated Scientist with significant experience in large-molecule process development using standard bioprocess unit operations (e.g. reactions, mixing, chromatography, tangential flow and/or normal filtration).
Working in a highly collaborative environment, the successful candidate will:
- Apply deep knowledge in nucleic acid research to develop robust, scalable and well-characterized processes for the manufacture of mRNA Vaccines using QbD principles
- Develop scale-down process models and perform process characterization utilizing DOE principles
- Manage and perform transfer of manufacturing processes from development labs to GMP facilities on firm timelines
- Develop new innovative technologies and approaches to fit current and future manufacturing needs
- Support the procurement of materials and manufacturing equipment (possibly custom)
- Prioritize work and leadership across multiple process development and manufacturing programs
- Independently carry out and document experiments, interpret data, and maintain good scientific process.
- Represent the group in cross-functional program teams and translate project goals into actionable plans
We are looking for professionals with these required skills to achieve our goals:
- BS with a minimum of 8+ years, MS with a minimum of 6+ years, or PhD with minimum of 2+ years of industry experience in bioprocess development and/or manufacturing sciences
- Degree in Molecular Biology, Biotechnology, Bioengineering, Chemical Engineering or a related scientific field
- Experience in process development (late-phase preferred) and process technology transfer for large biomolecules using QbD principles (sender or receiver)
- Experience in nucleic acids (RNA/DNA) to support process development of RNA vaccine candidates
- Experience in the large molecule regulatory environment, particularly FDA/ICH/ISPE guidelines on risk management, technology transfer and process validation
If you have the following characteristics, it would be a plus:
- Exceptional leadership, prioritization and project management skills
- Detail oriented; possess problem solving skills, and the ability to handle multiple tasks.
- Strong interpersonal skills with an eagerness to work with and support colleagues in a cross-functional collaborative environment
- Ability to effectively document and communicate results
- Knowledge of the 360° aspects of biomanufacturing for (bio)-pharmaceutical applications
- Knowledge of process development and biomanufacturing technologies and trends in the field
- Proven track record in bioprocess development for the biomanufacturing of nucleic acids, preferably RNA
- Experience and understanding in nucleic acid analytical technologies.
- Working experience with gene therapies or specifically mRNA-based vaccines or therapeutics.
- Broad understanding of overall process development and analytical development activities required for CMC support.
- Knowledge and understanding of Quality by Design, as applied to biologics from an early stage, would be an advantage.
- Team player in a cross-functional collaborative environment: effectively partner with diverse team members from various functions, multiple countries and members at various levels in organization
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. *This is a job description to aide in the job posting, but does not include all job evaluation details.
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