Expert Scientist, Upstream Early Development, Early Development & SAM CoE, Technical R&D

Rockville, MD
December 15 2020
Organization Type
Are you a motivated scientist, interested in a key role in the early Upstream cell culture process development? Are you interested in contributing your knowledge, skills, energy and creativity to the Early Development and Self Amplifying mRNA Center of Excellence group within Technical R&D Drug Substance, R&D Center, Rockville, MD.? If so, this Expert Scientist, Upstream Process Development role could be an ideal opportunity to explore.

As an Expert Scientist, Upstream Early Development, Early Development & SAM CoE ,Technical R&D, you will play a key role as a process development expert working on innovative recombinant protein-based antigen expression projects and platforms. The position will combine lab-based experimental work (60%-70% of time) and project coordination within a cross-functional group of CMC Expert Scientists working on high impact and visibility vaccine programs.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following :
  • Kick-start design and development of backbone Upstream processes for mammalian (primarily CHO) antigen expression projects from cell line development on to preparation for phase I development
  • You will be responsible for innovations in the CHO platform with the aim of implementing ‘technology of the future' at bench scale and helping to prepare the process for use in larger- scale and late-stage manufacturing. Knowledge of state-of-the-art cell culture technology and techniques, and a flair for assessing their utility and implementing these innovations are essential for this role.
  • Facilitate process transfer to development units in charge of Phase I/II/III process development
  • Interface with in-process analytical and analytical development to support robust early process and product characterization
  • Support early project transition between discovery/pre-clinical and process development functions
  • Streamline antigen development workflows related to clone selection, cell banking, process development and transfer
  • Serve as a subject matter expert for Upstream process development, interface with Quality and Regulatory to support project documentation and CMC submissions
  • Prioritize the deliverables from multiple programs and competing interests
  • Train and mentor junior staff

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • PhD; or master's degree with 3 years; or BS with 5 year relevant experiences
  • Ability to cross-train and collaborate with other process development functions, in-process analytics and analytical development.
  • Ability to plan, execute and perform data analysis using DoE, MVA and other advanced statistical approach.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Understanding of overall CMC upstream process development and analytical development activities
  • Mammalian cell line development experience
  • Hands-on experiences with small scale bioreactors (up to 50L ) and(or) mini- bioreactors;
  • Experience in media and feed optimization and metabolite analysis
  • Prior experience in the vaccine development field
  • Self Starter and quick learner

Why GSK?

Our values and expectationsare 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.


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