Expert Scientist - Drug Product Development Engineer
Site Name: USA - Maryland - Rockville Posted Date: Mar 3 2021 The Expert Scientist in the Drug Product Development team is expected to lead, design and execute scientific studies in support of technical programs as they progress from early development into Phase I/ II, Phase III, technology transfer and process performance qualification at the intended commercial site. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Design, test, optimize and build next-generation manufacturing systems to produce vaccine delivery vehicles. Enable the paradigm of continuous manufacturing by linking individual drug product unit operations together in an end-to-end manner. Integrate Process Analytical Technologies (PAT) and process modeling to enable the creation and deployment of manufacturing Digital Twins. Work with external/internal partners to enable full automation and control of drug product manufacturing processes. Design and execute formulation and process studies to maximize drug product stability. Design and lead specific development workstreams autonomously, in line with business priorities, following the Quality by Design framework. Independently responsible for the conception, design, implementation, and interpretation of scientific and technical data to support projects. Function effectively as a core team member on multiple concurrent project workstreams and established work processes. Solve complex problems through collaborations with others, taking a new perspective on existing solutions. Generate strong relationships in the area of technical development with high quality partners beneficial to the organization, both internally and externally, to strengthen development/implementation of new methods/technologies. Prepare and present scientific data within Technical R&D (TRD) including Technical Development Team and may represent GSK externally (conferences, etc) Author and review technical protocols, reports and manufacturing support documents in support of various project development stages. Utilize technical process knowledge to meet regulatory requirements appropriate for stage of development. Communicate effectively within TRD, with other departments and with external stakeholders and can defend scientific and technical decisions at the appropriate technical board. Benchmark specific technologies in own functional area to bring technology to state of the art. Contribute to and drive strategy and technical development planning and accountability in the execution thereof. Ensure execution of the function's risk assessment and escalate at relevant bodies. Development of mitigation plans. Lead and implement GxP / EHS / QA rules and regulations Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: PhD in Chemical Engineering, Process Engineering or a related scientific field with 3+ years of post-doc and/or job-related experience, or MS with 6+ years of experience, or BS with 9+ years of experience Experience in biopharmaceuticals and/or vaccine development process Experience in processes and unit operations used to manufacture biopharmaceuticals and/or vaccines Experience in process automation, programmable logic controllers, distributed control systems, and OPC DA/UA communications Knowledge of sterile drug product manufacturing Knowledge of drug product formulations and associated technologies Preferred Qualifications: If you have the following characteristics, it would be a plus: Excellent presentation, interpersonal and communication skills Ability to effectively work and perform within a team of dedicated scientists Ability to work with cross-functional teams and in matrix environments Competency to influence scientific and technical vision and strategy Must be able to work with individuals having different cultures/values Experience in technology transfer in manufacturing 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: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk, governance and control, managing ambiguity and paradox. Managing individual performance. Creating a performance culture and driving results, prioritisation, execution, delivering performance. Setting strategic direction and leading on-going organisational transformation. Building a resilient organisation. Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit. 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