Principal Scientist in Steriles Process Engineering and Analytics

Business Introduction
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.

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Our approach to R&D

Position Summary

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 Technology Development and Process Engineering team would be the right fit for you. Our team in the Technology Development and 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 Principal 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 Sterile drug products (Biopharms, small molecule suspensions, ADCs, oligonucleotides, Vaccines) 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 careermulti-variant analysis and data driven decision-making teams to ensure that we have the right infrastructure components to power our platforms and services reliably and securely.

Key responsibilities include:

• Work as part of a multi-disciplinary development team, liaising efficiently with Formulators, Modelers, 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 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.

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Ph.D. in Chemical Engineering, Biochemical Engineering, or related field

• Experience in protein formulation and/or drug product development and technology transfer

• OR MS degree with 10+ years of related experience

• OR BS degree with 13+ years of related experience

Preferred Qualifications:

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

• Experience in or exposure in an academic context to Sterile drug product (e.g., Biopharma, suspensions, ADCs, oligonucleotides, or Vaccines) development drug product process development, characterization, scale -up and technology transfer modelling, and, to deliver processes that are well understood

• 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

Location and Working Model
This role is located in the United States. The position follows a hybrid working model with an expectation of regular on-site collaboration. Exact on-site days will be agreed with the hiring manager to balance project needs and flexibility.

How to apply
If this role aligns with your skills and ambitions, we encourage you to apply. Please submit your CV and a brief note explaining your interest and relevant experience. We look forward to hearing how you can help us unite science, technology and talent to get ahead of disease together.

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 purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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