Expert Scientist, Upstream Process Development- Technical Development Drug Substance
- Rockville, MD
Site Name: USA - Maryland - Rockville
Posted Date: Aug 31 2020
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- Technical R&D Drug Substance role could be an ideal opportunity to explore.
As an Expert Scientist, Upstream Process Development- Technical R&D Drug Substance, 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 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 prepare for phase I development
- You will be responsible for innovation 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.
- Perform hands-on bioreactor runs (mostly low-scale and HTP), support equipment maintenance and provide other laboratory systems' oversight
- 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
- Support new technology assessment and licensing activities
- 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:
- An advanced degree in biology, biochemistry, chemical engineering, bioinformatics or related biopharmaceutical process sciences
- PhD and 3+ years of industry experience or master's degree with 8+ years of industry experience
- Proven expertise & experience in Upstream mammalian cell culture process development
- Hand-on experience in working with small scale bioreactors (up to 50L ) and(or) mini-bioreactors; ability to plan, execute and perform data analysis using design of experiments and other advanced statistical approaches
- Ability to cross-train and collaborate with other process development functions, in-process analytics and analytical development.
Preferred Qualifications: If you have the following characteristics, it would be a plus:
- Background in molecular biology, cell and gene therapy
- Mammalian cell line development experience
- Experience in media and feed optimization and metabolite analysis
- Prior experience in the vaccine development field
- Broad understanding of overall process development and analytical development activities required for CMC support.
- 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.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
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