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.
As a Process Engineer, 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.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following
- Work as part of 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 and contribute to the technical transfer activities and reports as appropriate for transfer to the manufacturing site (internal or external) by providing experimental data, technical insight and modelling of data to solve complex process development problems using excellent practical and theoretical understanding.
- 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 supporting platform development workstreams to assess, develop and implement new manufacturing platforms, automate development work packages and establishing control strategies.
- Develop as an expert in specific unit operations. 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
- Prepare and deliver Process Engineering and Analytics-relevant sections of technical and governance presentations and respond to resulting questions. Additionally work very closely with automation team and data scientists to automate work packages and standardize data generation and analysis.
- 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
Why you? Basic Qualifications:
- 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.
We are looking for professionals with these required skills to achieve our goals:
- MS degree in Chemical Engineering, Pharmaceutical Sciences or related field with 1-3 years of protein formulation, process development and drug delivery development experience; or BS degree with 3-6 years of similar experience.
If you have the following characteristics, it would be a plus:
- 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
- Experience in the operation of state-of-the-art laboratory equipment, equipment automation, data automation, PAT tools and modelling software.
- Experience evaluating, developing, and qualifying manufacturing equipment.
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges we've made to our business in over 20 years.We're on track to separate and create two new companies in 2022:
New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and geneticsscience; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culturethat isambitious for patients
- so we deliver what matters better and faster; accountable for impact
- with clear ownership ofgoals and support to succeed; andwhere we do the right thing
. So, if you're ready to improve the lives of billions, join us at thisexciting moment in our journey. Join our challenge to get Ahead Together.
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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.
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