Director, Biopharm Semi-continuous Manuf. Tech Development Leader
Are you a seasoned leader with a proven track record in monoclonal antibody (mAb) process development along with exceptional line and matrix leadership skills? Are you motivated to apply these skills to develop and industrialize a modular and semi-continuous way to manufacture monoclonal antibodies (mAbs)?
The Advanced Manufacturing Technology (AMT) group in GSK Pharma R&D was created to deliver GSK's Manufacturing Technology Roadmap with the global objective to transform the way GSK manufactures its bio/pharmaceutical products. Recently, we have been focusing our efforts in looking at alternatives to traditional biologics/biopharmaceutical manufacture.
The Biopharm workstream of the Advanced Manufacturing Technology department have an approved and aligned technology development project co-sponsored by the biopharmaceutical areas of R&D and Global Manufacturing organizations to incubate and rapidly industrialize a next generation modular Agile manufacturing platform for monoclonal antibodies (mAbs) and other biological products. The 'Agile' biopharm manufacturing platform uses smaller equipment operated semi-continuously with sophisticated process analytical tools and automation in a closed manner to reduce the space (i.e. capital) and people required to produce biopharmaceutical drug substance.
You will report into the Biopharm Technology Development Leader and will be both inward facing in terms of understanding the technology needs and gaps relative to the Agile Platform and, importantly, outward facing to ensure that GSK fully understand and make best use of the new emerging ideas, science and technologies in this space.
• Deliver the manufacturing platform through the leadership of a multi-disciplinary/multi-departmental matrix team and direct line (> 20 people total) which will include several sub-teams.
• Design and finalize P&IDs, process control diagrams needed for detailed design and construction of the manufacturing platform.
• Manage the skid fabrication and construction timelines and plan for Factory and Site Acceptance Testing (FAT and SAT).
• Ensure stakeholder management through a governance structure involving a Steering Team and a Senior Sponsor group.
• Ensure external engagement with potential industry partners and regulatory authorities to ensure the seamless industrialization of the platform
• Seek technology advances in large molecule manufacturing,
• Make recommendations/business cases to pursue opportunities that can accelerate our manufacturing roadmap
• Work with product CMC Matrix team leaders to identify assets that can adopt the platform to meet their lifecycle plans.
• Conduct technical de-risking activities of the unit operations for the selected assets.
• Ensure the principles of quality by design (QbD) and quality risk management are applied appropriately towards the platform.
• Direct line leadership of > 5 full-time and contract staff who will be involved in the Agile platform activities.
• Conduct performance/development reviews
• Build a strong relationship with external vendor to deliver against the milestones.
• Be a member of the Biopharm-AMT leadership team and contribute to running the department,
• Assist the department head with running a high performing department.
When applying for this role, please use the 'cover letter' of the on-line application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
BECAUSE YOU HAVE:
• A Degree in Chemical/Biochemical Engineering, or equivalent
• At least 7 years of direct experience of monoclonal antibody (mAb) cell culture and downstream process development
• At least 5 years of Matrix leadership experience
development, manufacture, and scale-up of biopharmaceuticals/biologics, through demonstrated experience in the relevant CMC and supply chain aspects related to process development, product industrialization, and product file and launch.
• Understanding of Comparability Requirements and Risks Associated with CMC Changes for biologics/biopharmaceuticals
• Familiarity with GMP operations and working in an FDA regulated environment
• Demonstrated knowledge and experience of technology search, technology development and technology portfolio management activities.
• Demonstrated effective interpersonal, communication, and negotiation skills across internal and external stakeholders and senior managers
You must be
• Able to work in the Philadelphia area in our newly redesigned R&D facility.
• Available to travel to oversee 3rd parties.
• Masters + 16 years of relevant experience)
• A Ph.D. related to Chemical/Biochemical Engineering or equivalent
(PhD + 12 years of relevant experience or
• Experience with continuous processing of biologics/biopharmaceuticals
• Experience with developing and implementing novel process technology in a GMP environment
• Demonstrated ability to technically influence senior stakeholders
• Experience working with 3rd party vendors/suppliers
• Understanding of process controls principles to equipment, instrumentation, and networks to troubleshoot automation related problems
• Influential, yet challenging
• Courage to lead and make difficult decisions
• Logical and independent thinking
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
You may apply for this position online by selecting the Apply now button.
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