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 Technology Development and Process Engineering opportunity could be an exciting opportunity to consider.

GlaxoSmithKline is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery of strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer.

Drug Product Development (part of the wider Medicine Development and Supply organization) 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 both small molecule and biopharm drug product/ device development and packaging. We also pioneer innovative technologies to improve robustness, reduce cost of goods, and improve the patient experience.

As a Scientific Leader, 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 across all drug product development work packages. The role may require management of a direct report or reports.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following.

• Work as process engineering and analytics (PE&A) lead in a multi-disciplinary development team, liaising efficiently with Formulators, Modellers, Process Analytical Technology (PAT) Scientists, automation experts, data scientists and device engineers, to deliver the work packages required to understand drug product unit operations and scale these-up effectively.

• Actively participate in technical reviews on projects, lead the technical transfer of processes, prepare functional project plans, and ensure timely execution. Contribute to CMC and MPD team planning and objective setting, agreeing priorities and coordinating PE&A activities that support delivery of objectives.

• Ensure proper Process Engineering decisions are taken at appropriate milestones within the project plan to accelerate early phase formulation and process design and minimize number of DOE’s for scalability assessments and API consumption throughout the development life-cycle.

• 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 and establishing control strategies. Be accountable for platform robustness across the portfolio.

• The job holder may act as an expert in specific unit operations. As such, they will be expected to master a body of knowledge for that unit operation and use this to act as the functional expert in the department. This expertise will be focused on platform and process primarily within the sterile biopharm portfolio

• 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.

• 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.

• Enable sound decisions by your influence in matrix teams and technical governance, through depth of technical knowledge and effective communication, to collaborate actively with R&D Pilot Plants and Global Supply Chain manufacturing sites

• 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:

The ideal candidate will have a:

• Ph.D. in Chemical Engineering, Pharmaceutical Sciences or related field with 4+ years of protein formulation and/or drug product development experience; or MS degree with 7+ years of similar experience; or BS degree with 10+ or more years of protein formulation and/or drug product development experience

Preferred Qualifications

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

• Experience in Biopharm 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 evaluating, developing, and qualifying manufacturing equipment.
• Establishing control strategy for biopharm drug product manufacturing
• Proven ability to lead collaboratively in a matrix style environment
• Authoring (or co-authoring) of publication(s) in peer-reviewed scientific journals
• Author DP sections of regulatory documents (IND/IMPD, BLA/MAA/JNDA, etc.)
• Biopharmaceutical product development including formulation, stability, process development/characterization and technical transfer
• Bioanalytical and biophysical testing, and data analysis
• Demonstration of data integrity principles
• Mentoring/developing staff in proper scientific study design, execution, and report writing

#LI-GSK

#CMCDevelopmentGSK

Why GSK?

We’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated.

In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention.

Find out more:

Our approach to R&D.

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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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.

At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.

GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.

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.