Onsite: Rockville, MD
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 cell line development to drive the establishment of robust CHO based production cell lines for innovative recombinant protein/adjuvanted vaccine pipeline and platform development. 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 preGMP-grade mammalian (primarily CHO) cell lines for commercial manufacture of vaccine products.
- Serve as a subject matter expert (SME) for next-generation cell line development and interface with Quality and Regulatory to support project documentation and CMC regulatory submissions (including raw material control section and cell line derivation report)
- Drive the development, evaluation, and implementation of technologies or processes that improve efficiency, performance, and capabilities of CLD platforms for vaccines
- Development and implementation of cutting-edge cell line development workflow and cell line engineering technologies for company pipeline CLD campaign and/or next-generation CHO engineering with improved production efficiency (yield, quality and speed) for commercial vaccine products.
- Keep abreast of industrial trends related to novel cell line development workflow and platform development technologies.
- Keep updated with the latest version of regulatory guidance related to cell line development and implement novel regulatory pathway for rapid CMC submission
- Work as part of a multi-disciplinary team to deliver on project objectives
- Communicate project progress through internal project meetings and external scientific knowledge sharing forums
- Author/Coauthor peer-reviewed manuscripts, patents, and internal/external conference oral/poster presentations
- Independently design and execute laboratory experiments.
- Comply with data integrity requirements for laboratory work.
- Partner with diverse team members from various functions, multiple countries and members at various levels in organization.
- 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.
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
- Minimum 2 years experience with mammalian cell culture/cell line development of large biomolecule product streams (Recombinant protein, subunit vaccines, and mAb/bsAbs/msAbs
- Minimum 2 years hands-on experience with vector design and optimization for complex recombinant protein production 2-year hands-on experience with aseptic small-scale (plate- to shake flask-based) mammalian cell culture techniques, including transfection and clonal derivation and screening
- Minimum 2 years hands-on experience with common nucleic acid- and protein-based analytic assays related with early CQA/PA assessment for clone selection, including PCR, ELISA and Octet.
If you have the following characteristics, it would be a plus:
WHY GSK? Our values and expectations
- Experiences with cell line development campaign for commercial vaccines and biologics products and related CMC filling (including cell line derivation reports, material control section and risk assessment)
- Experience with high-throughput, robotic cell line development instruments such as FACS and/or Beacon
- Track-record of success in driving CLD workflow innovations as demonstrated by industrial pipeline project implementation, peer-reviewed publications and patents
- Working knowledge on development and implementation of advanced in-process-analytics related with cell line development for complex biologicals, such as NGS, ddPCR, LC-MS, HPLC and multiplex based antigenicity profiling. Knowledge and experience with implementation of cell line engineering techniques such as CRISPR, RMCE, and transposon-based techniques for pipeline projects.
- 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 restriction
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:
*This is a job description to aide in the job posting, but does not include all job evaluation details.
- 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
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.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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