GlaxoSmithKline
Principal Scientist/Investigator – Sterile Process Engineering
GlaxoSmithKline, Collegeville, Pennsylvania, United States, 19426
Site Name:
USA - Pennsylvania - Upper ProvidencePosted Date:
Sep 4 2024Are 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.Using your sound practical and theoretical understanding, ensure that appropriate experimental data and models are used to solve complex process development problems.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 and externally, ensuring appropriate scientific review is in place throughout development and prior to key Project milestones.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.Become an expert in specific unit operations primarily within the sterile biopharm portfolio.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.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.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-GSKPlease visit
GSK US Benefits Summary
to learn more about the comprehensive benefits program GSK offers US employees.Why GSK?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.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.
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USA - Pennsylvania - Upper ProvidencePosted Date:
Sep 4 2024Are 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.Using your sound practical and theoretical understanding, ensure that appropriate experimental data and models are used to solve complex process development problems.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 and externally, ensuring appropriate scientific review is in place throughout development and prior to key Project milestones.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.Become an expert in specific unit operations primarily within the sterile biopharm portfolio.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.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.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-GSKPlease visit
GSK US Benefits Summary
to learn more about the comprehensive benefits program GSK offers US employees.Why GSK?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.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.
#J-18808-Ljbffr