Expert Scientist RNA Bioprocess - SAM/mRNA
Site Name: USA - Maryland - Rockville Posted Date: Jun 23 2021 Are you energized by the challenge of shaping and accelerating the scientific expertise of a biology program? If so, this Expert Scientist RNA Bioprocess opportunity could be an exciting opportunity to consider. The Early Development and SAM Center of Excellence, Technical Research & Development, GSK Vaccines is looking for a 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). This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… 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 Represent the group in cross-functional program teams and translate project goals into actionable plans Why you? Basic Qualifications: 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 Understanding of nucleic acids (RNA/DNA) to support process development of RNA vaccine candidates Experience in process development (late-phase preferred) and process technology transfer for large biomolecules using QbD principles (sender or receiver) Knowledge of the large molecule regulatory environment, particularly FDA/ICH/ISPE guidelines on risk management, technology transfer and process validation Preferred Qualifications: If you have the following characteristics, it would be a plus: Exceptional leadership, prioritization and project management skills Ability to effectively document and communicate results Strong interpersonal skills with an eagerness to support colleagues Ability to collaborate effectively in a dynamic, cross-functional matrix environment 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 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. 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). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.