Investigator/Principle Investigator – Steriles (Biopharms And Small Molecules) Process Engineering & Analytics

Site Name: USA - Pennsylvania - Upper Providence
Posted Date: Jul 6 2023
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 small molecule, oligonucleotide 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 an Investigator/Principal Investigator, you will employ knowledge and experience of drug product unit operations, Process Engineering, PAT, and modelling to assess, develop and implement new manufacturing platforms and support scale-up, technology transfer and manufacture of Steriles small molecule, oligonucleotide and biopharm drug product through to commercialization. You will work very closely with formulators, materials scientists, modelers, automation experts and data scientists to enable efficiencies across all drug product development work packages.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

• Make innovative contributions to the department by leading platform development workstreams to assess, develop and implement new manufacturing/PAT platforms. Be an expert and be accountable for manufacturing/PAT platform robustness across the portfolio.
• Work on developing processes for ready to use (combination products) and lyophilized drug product dosage forms.
• Actively participate in technical reviews on projects, lead the technical transfer of processes, and ensure timely execution, while collaborating actively with R&D Pilot Plants and Global Supply Chain manufacturing sites. Contribute to CMC and MPD team planning, agreeing priorities and coordinating PE&A activities that support delivery of objectives. Prepare and deliver Process Engineering and Analytics-relevant sections of technical presentations and respond to resulting questions. Identify and escalate Process Engineering and Analytics-related risks at scientific reviews.
• Ensure proper Process Engineering and PAT related 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.
• Work as process engineering and analytics (PE&A) lead in a multi-disciplinary development team, liaising efficiently with Formulators, Modellers, automation experts, data scientists and device engineers, to deliver the work packages required to understand drug product unit operations and scale these-up effectively.
• 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.
• Contribute to department PAT strategy, as Process Analytical Technology (PAT) scientist to employ new PAT tools for Steriles projects, deploy PAT in R&D and/or Manufacturing plants as per the pipeline need.
• 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 sterile liquid and lyophilized drug product development, participating in internal or external technical focus networks, external collaborations, and applying knowledge of the current literature.
• Coauthor sections of regulatory documents relevant to Process Engineering and analytics platforms.

Why you?
Basic Qualifications:

• PhD in Pharmaceutical Sciences, Biotechnology, Chemistry, Biology, Physics, Chemical Engineering, mechanical engineering or any engineering field
• BS with 5+ years experience in Pharmaceutical Sciences, Biotechnology, Chemistry, Biology, Physics, Chemical Engineering, mechanical engineering or any engineering field
• Experience with Lyophilization/Freeze Drying
• MS with 3+ years’ experience in Pharmaceutical Sciences, Biotechnology, Chemistry, Biology, Physics, Chemical Engineering, mechanical engineering or any engineering field

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

• Authoring (or co-authoring) of publication(s) in peer-reviewed scientific journals, DP sections of regulatory documents (IND/IMPD, NDA/BLA/MAA, etc.)
• Steriles product development including formulation, stability, process development/characterization and technical transfer
• The ideal candidate will have a Ph.D. in Chemical Engineering, Pharmaceutical Sciences or related field with 0-3 years of Steriles drug product – Process Engineering development experience; or MS degree with 5+ years of similar experience; or BS degree with 7+ years of experience.
• Establishing control strategy for Steriles drug product manufacturing
• Experience evaluating, developing, and qualifying manufacturing equipment.
• Proven ability to lead collaboratively in a matrix style environment
• Mentoring/developing staff in proper scientific study design, execution, and report writing
• Expertise in developing lyophilized Drug product manufacturing processes.
• Experience in the application of state-of-the-art laboratory equipment, equipment automation, data automation, PAT tools and modelling software.
• Bioanalytical and biophysical testing, and data analysis
• Demonstration of data integrity principles
• Experience in Steriles drug product process development, PAT, characterization, scale -up and technology transfer, modelling, to deliver processes that are well understood

#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 positively impact the health of 2.5 billion people by the end of 2030.
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