We are building a state-of-the-art clinical manufacturing group which delivers new biotherapeutics for unmet medical need. Together with our therapy area partners, we discover, develop and manufacture a novel portfolio of exciting medicines to benefit patients around the world. If you aim to be part of a global cutting-edge drug development and discovery organization and are motivated to bring lifesaving drugs to patients , join us!
to learn more about GSK Biopharm.
Are you looking for an impactful role that leverages your expertise and ability to build exceptional relationships with trusted global partners to develop an increased number of transformative medicines for our patients? If so, this Investigator, Process Technology, GMP Operations lies withina rapidly growing, empowered, innovative and agile clinical manufacturing organization and could be an ideal opportunity to explore.
As an Investigator within our Process Technology, GMP Operations team, you will lead the industrialization and introduction of new Single-Use (SU) process technologies for upstream and downstream manufacturing, as well as collaborate with CMC matrix teams and GSK Biopharm manufacturing sites to deliver a robust SU technology manufacturing platform and progress the GSK Biopharm portfolio.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Why you? Basic Qualifications:
- Conducts technology transfer from Bioprocess development groups (internal and/or external) to GMP Operations or third-party contract manufacturers. Conducts facility fit assessments and leads process introduction activities, including SU technologies. Monitors technical operations of the process through communication with Manufacturing Scientists. Coordinates efforts to transfer technology forward to contract manufacturers and other partners. Responsible for authoring and approval of technical batch documentation.
- Coordinates activities between Development groups. Represents the Process Technology department at multi-disciplinary matrix teams. Presents results/conclusions at these meetings.
- Ensuring that manufacturing campaign data and supporting information is sufficient to support regulatory packages and filings. Authors manufacturing and process sections of regulatory submissions and responses to regulatory questions.
- Provides training and guidance to Manufacturing Scientists on SU systems and technologies.
- Monitors use of SU technologies for upstream and downstream production. Collects information and prepares/maintains a campaign summary database of process knowledge, to be leveraged as assets progress in the biopharmaceutical development cycle. Analyzes results fully and recommends follow-up actions. Leads troubleshooting activities.
- Ensures that processes being transferred and supporting documentation are sufficient to support consistent production and regulatory filings. Conducts facility fit analysis and coordinates process introduction activities.
- Prepares and/or approves documents for use in technology transfer and manufacturing. Authors documents for regulatory purposes.
- Directs the industrialization of SU technology essential to large scale cGMP production. Solves process and equipment problems. Recommends equipment and procedures. Keeps aware of new technology developments. Technically expert in cell culture, fermentation, and/or purification technologies, with knowledge in all areas desirable.
- Provides support for technology transfer from CMOs into Manufacturing Operations. May provide oversight of manufacturing activities at CMO. International and domestic travel may be required (up to 50%).
- Prepares and approves SOP's in areas of expertise.
We are looking for professionals with these required skills to achieve our goals:
- B.S. in chemical engineering, biochemical sciences, or related engineering/scientific disciplines, with 6+ years of experience in Lab/pilot scale cell culture operations (SU bioreactor operations, alternating tangential flow filtration (ATF), depth filtration, centrifugation and media preparation), or lab/pilot scale protein purification methods, (chromatography, ultrafiltration, depth filtration, centrifugation and buffer preparation)
- Knowledge of cGMPs and regulatory requirements.
- Experience in project management and delivery
- Experience in technology transfer and process scale-up
If you have the following characteristics, it would be a plus:
- Ph.D. in chemical engineering, biochemical sciences, or related engineering/scientific disciplines with 2+ years relevant experience, OR M.S. in these disciplines with 4+ years relevant experience, in Lab/pilot scale cell culture operations (SU bioreactor operations, alternating tangential flow filtration (ATF), depth filtration, centrifugation and media preparation), and lab/pilot scale protein purification methods, (chromatography, ultrafiltration, depth filtration, centrifugation and buffer preparation)
- Excellent troubleshooting/problem analysis skills, including experience with Lean Sigma and Root Cause Analysis methodologies.
- Excellent written and oral communications skills.
- Excellent organizational, collaboration, and teamwork skills.
- Strong interpersonal and leadership skills.
Uniting science, talent, and technology to get ahead of disease together
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we're making the most significant changes 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 genetics science; 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 disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as 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 culture that is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership of goals and support to succeed; and where we do the right thing . So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.
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