Process Analytical Support Investigator, Downstream Process Development
Site Name: USA - Pennsylvania - King of Prussia Posted Date: Jun 16 2021 Are you looking for a challenging opportunity that allows you to leverage your technical expertise to accelerate delivery in biopharmaceuticals? If so, this Process Analytical Support Investigator, Downstream Process Development role could be an exciting opportunity to explore. Biopharm Process Development is a highly experienced Chemistry, Manufacturing and Controls (CMC) organization accountable for delivering robust, cost effective and competitive products and manufacturing processes spanning the full life-cycle of asset development from Discovery through commercialization. These activities are delivered through state-of-the-art internal facilities as well as strategic external partners. Collectively, the team is accountable for CMC activities encompassing cell line development, cell culture/ microbial fermentation, purification development, and drug product/ device development. We also pioneer innovative technologies to improve robustness, reduce cost of goods, and improve the patient experience. Within Biopharm Process Development, the Downstream Process Development department is responsible for the development of purification processes for the manufacture of GSK's Biopharm assets. The Department is also responsible for the scale-up and tech transfer of the processes to manufacturing facilities all over the world. Our aim is to integrate innovative process platforms, automation and advanced data analytics into the downstream process development workflow. In our mission, we follow the science and are committed to the design, development, and transfer of the most robust, well-understood, and well-characterized downstream manufacturing processes and platforms that will ensure quality and reliable supply of medicines for the patient. The Downstream Process Development (DPD) organization in GSK is seeking a highly motivated scientist to develop, implement, and sustain an analytical strategy that will most effectively support the Drug Substance process development environment. This is an exciting and unique role and the applicant will have the opportunity to seek, incubate and implement novel at/in/off-line analytical technologies to monitor product quality and understand manufacturing processes for therapeutic protein development. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Drive development of advanced analytical technology to enable at/in/off-line monitoring of downstream processes. Lead the departmental analytical focus group; work collaboratively across departments and with external vendors. Seek, incubate and implement new process analytical technologies to expand GSK's capabilities for process monitoring and control, including technologies suitable for continuous Drug Substance manufacturing. Provide hands-on support to develop and sustain SiPAT knowledge for continuous process analytical technologies, including the successful function and operation of automated sampling units used during continuous processing (e.g. SegFlow). Work with modelling colleagues to further process modelling development and implementation in the continuous platform. Organize and sponsor matrix team groups to increase technical capability within the department. Interface with analytical development scientists to best utilize available technologies and develop novel analytical techniques for downstream process development. Work with analytical colleagues to assess potential correlations between process parameters and product quality attributes and develop possible feedback control loops. Communicate analytical strategy and implementation plans to downstream process. Define the Technical and Business Acceptance criteria to be met for the successful adoption of the new technologies for downstream use. Design and execute protocols for the objective evaluation of analytics with the aim to gather compelling evidence for implementation. Supervise the installation of new equipment in line with safety and quality requirements and obtain necessary training. Interpret, discuss and communicate findings to internal and external stakeholders in a timely manner. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: PhD with 0+ years' experience or Masters / Bachelors with 5+ years' experience in Analytical Chemistry, Biochemistry, Chemical Engineering, Biology, or a similar scientific discipline. Experience in the analysis of proteins including sample preparation, chromatography (reverse phase, size exclusion chromatography, ion exchange), capillary electrophoresis, and spectroscopic methods. Experience in downstream biopharmaceutical processes and process analytical technologies. Experience in project management skills. Preferred Qualifications: If you have the following characteristics, it would be a plus: Track record in identification, development, and implementation of novel analytical technologies. Knowledge in protein purification unit operations Exposure to continuous processing techniques An understanding of statistics, multi variate analysis, chemometrics, and modelling. 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 gskbiopharm_development 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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