Principal Scientist/Investigator - Sterile Process Engineering

Are you energized by the challenge of designing innovative ways to use Engineering, Process Analytics Technologies, Automation and Modelling to develop medicines for patients? If so, this opportunity within the Sterile Process Engineering team would be the right fit for you. Our team in the Process Engineering group is passionate about the work we do, and we'd be eager to welcome individuals with a similar interest in using technology to develop medicines.

As an Investigator, you will employ knowledge and experience of drug product unit operations, Process Engineering, and modelling to assess, develop and implement new manufacturing platforms and support scale-up, technology transfer and manufacture of Biopharmaceutical drug product through to commercialization. You will work very closely with automation experts and data scientists to enable efficiencies during drug product development.

This multi-disciplinary role will provide YOU a great opportunity to pursue your interests and develop your career. Our group has great mentors who are generous with their time and guide members in their career path. You will have the opportunity to lead key activities in Drug Product Development to progress YOUR career.

Some of the key activities you will be involved with are:

• Work as part of a multi-disciplinary development team, liaising efficiently with Formulators, Modellers, Process Analytical Technology (PAT) scientists, automation experts, data scientists, device engineers, and engineers from R&D Pilot Plants and Global Supply Chain manufacturing sites, to systematically understand unit operations involved in drug product manufacture and to scale-up these processes effectively.
• Actively participate in and lead technical reviews on projects, and contribute to the technical transfer of processes, including the leadership of technical transfer activities on behalf of the discipline, preparing functional project plans, and ensuring timely execution. Contribute to CMC and MPD team planning and objective setting, agreeing priorities and coordinating Process Engineering and Analytics activities that support delivery of objectives.
• Using your sound practical and theoretical understanding, ensure that appropriate experimental data and models are used to solve complex process development problems. Advance scientific understanding and improve current ways of working in field of expertise by actively championing deployment of new automation and PAT tools and models for drug product development, participating in internal or external technical focus networks, external collaborations with academics, and applying knowledge of the current literature.
• Minimize number of DOE's for scalability assessments and API consumption throughout the development life-cycle by driving smart decisions at appropriate milestones within the project plan.
• Be technically persuasive both within GSK, for example, at project governance, with peers in other departments, or externally, with the academic community. Ensure appropriate scientific review is in place throughout development and prior to key Project milestones. Prepare and deliver Process Engineering and Analytics-relevant sections of technical and governance presentations and respond to resulting questions. Identify and escalate Process Engineering and Analytics-related risks at scientific reviews and through governance processes.
• Author sections of regulatory documents relevant to Process Engineering platforms (IND / IMPD submissions, marketing applications, CMC briefing etc.).
• Make innovative contributions to the department by leading platform development workstreams to assess, develop and implement new manufacturing platforms, automate development work packages and establishing control strategies. Be accountable for platform robustness across the portfolio.
• Become an expert in specific unit operations primarily within the sterile biopharm portfolio. Additionally work very closely with automation team and data scientists to automate work packages and standardize data generation and analysis.
• Utilize effective planning to deliver the above efficiently and where required, enable work packages to be automated or outsourced.
• Deliver the above in a precise and timely manner, adhering to safety and quality expectations. Comply with the requirements of Quality, Safety and GSK policies and procedures and ensure that GSK intellectual property is protected.

Why you?

Basic Qualifications:

• Ph.D. in Chemical Engineering, Pharmaceutical Sciences or related science/engineering field with 3+ years of protein formulation and/or drug product development experience; or, MS degree with 5+ protein formulation and/or drug product development experience; or, BS degree with 7+ or more protein formulation and/or drug product development experience .
• Experience in or exposure in an academic context to Biopharm drug product process development, characterization, scale -up and technology transfer modelling, and, to deliver processes that are well understood

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Experience in the application of state-of-the-art laboratory equipment, equipment automation, data automation, PAT tools and modelling software.
• Experience in evaluating, developing, and qualifying manufacturing equipment.
• Publications in peer reviewed journals

#LI-GSK

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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