Expert Scientist - Upstream CHO Protein Vaccines

Location: Rockville, MD - onsite

Expert Scientist Upstream CHO Protein Vaccines

Are you energized by a challenging role in biology, where scientific demand is driving team growth? If so, this Expert Scientist role would be a great opportunity to consider.

The Mammalian Expression Technology Center of Excellence (Technical Research & Development, GSK Vaccines) is seeking an enthusiastic, experienced, and motivated Expert Scientist with a strong understanding and experience in upstream scale-up technologies to drive the establishment of CHO based production cell lines and early upstream process flow for innovative recombinant protein/adjuvanted vaccine projects and platforms. Located in Rockville, MD, the position will contribute to the success of the GSK CHO recombinant protein vaccine platform.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

Design and Development of upstream processes for mammalian (primarily CHO) antigen expression projects in early stage. Streamline/harmonizing vaccine antigen development workflows related to upstream development Facilitate early on-boarding of pipeline programs from early discovery/preclinical function for acceleration, including providing early developability/manufacturability assessment. Facilitate process transfer to development units for later stage development/life cycle management in in Global Cell& Viral Drug Substance organization. Development of high throughput and robust upstream process development capabilities to support: Cell line development/bioprocess suitability study Cell culture design space definition Early CMC development (downstream development, analytical development, and drug product development) Discovery enablement (preclinical material supply) Establishing robust control strategy Media development and optimization

Support platformization efforts in the cell line development and upstream processing area Development/implementation of fit-for-purpose advanced data analytic (e.g. In-Silico modelling) technology for rapid upstream development. Serve as a subject matter expert for early upstream process development, stay ahead with the latest quality and regulatory guidance to support pipeline project documentation and accelerated CMC submissions. Partner with diverse team members from various functions, multiple countries and members at various levels in organization. Benchmark specific technologies in own functional area to bring technology to state of the art. Solve complex problems through analytical thinking to identify and understand alternatives using knowledge gained through formal education, experience and sound judgment. Prepare oral and written reports to communicate scientific findings and to support project documentation and CMC submissions. Comply with data integrity requirements for laboratory work.

Why you?

Basic Qualifications:

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

• Advanced Degree (Master with 6 years or PhD with 2 years of relevant experiences) in Biochemistry, Molecular Biology, Chemical Engineering, Biotechnology, Bioengineering, or a related scientific field.
• 2 or more years experience with mammalian cell culture of large biomolecule product streams (Recombinant protein, subunit vaccines, and mAb/bsAbs/msAbs.
• Minimum 1 year hands-on experience with bioreactor.
• Minimum 1 year working experience with process scale-up
• 2 or more years experience in research and development in a biopharmaceutical industry or government laboratory setting.

Preferred Qualifications:

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

• In-depth knowledge background in process scale-up for complex biomolecule production.
• Understanding of Quality by Design and the development of a process control strategy.
• Experiences with upstream process intensification (e.g. N-1/N-2 perfusion; concentrated fed-batch workstream)
• Strong hands-on experience with a wide range of upstream techniques for large molecule production, including AMBRs, Wave and SUBs at bench scale up to 50 L.
• Experience in advanced upstream data analytics tool including in-silico bioreactor simulations/digital twins and advanced statistic analysis (e.g. MVDA).
• Design and execute DOE studies & high-throughput screen for upstream process improvements and advancements including parameter optimization, scale-up, process window determination and process capability evaluation.
• Knowledge of technology transfer and GMP manufacturing.
• Be able to rapidly acquire project understanding and apply professional knowledge to project improvement.
• Demonstrated ability to efficiently work in a fast paced and fluid environment, changes in priority and timeline restrictions

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Continuously looking for opportunities to learn, build skills and share learning.
• Sustaining energy and well-being
• Building strong relationships and collaboration, honest and open conversations.
• Budgeting and cost-consciousness

*This is a job description to aide in the job posting, but does not include all job evaluation details.

*LI-GSK

#WYARD2022

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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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