GlaxoSmithKline (GSK) is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery for 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.
GSK’s Cell & Gene Therapy Platform CMC team is being expanded to support an increasing portfolio of cell and gene therapies. The team is responsible for delivering the Chemistry, Manufacturing and Controls (CMC) aspects of the projects from early phase to launch and the development of innovative technologies to enable step-change improvements to cell & gene therapy manufacture.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Work collaboratively with Cell & Gene Therapy Platform CMC cell process research and analytical development scientists to establish the cell process for cell and gene therapies through both well designed experiments performed in-house and through managing experiments to be performed by Contract Manufacturing Organisations (CMOs)
Delivery of Process Transfer Documents and lead effective technology transfer programs to both in-house and external (CMO) manufacturing facilities
Propose, design and conduct studies to develop and validate innovative technologies and approaches to make step-change improvements in process efficiency
Support development of a portfolio of ex vivo gene therapies from early to late stage by executing development work, reviewing data and supporting regulatory interactions
Responsible for preparation of relevant sections of regulatory filings
Responsible for compliant, clear and concise documentation and/or presentation of all experimental studies and results
Maintaining good working relationships with third parties (contractors, suppliers, academic and industry groups) to ensure successful process development and/or technology transfer
Why you?
Basic Qualifications:
Master’s degree in Biology, Cell Biology, Immunology, Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Materials Engineering or other related scientific or engineering discipline
Experience in the development and manufacture of biotherapeutics or cell and gene therapy products
Demonstrable ability to work independently
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
PhD in Biology, Cell Biology, Immunology, Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Materials Engineering or other related scientific or engineering discipline
Experience of technology transfer, establishment and qualification in GMP biopharmaceutical industry setting
Experience with process development using principles of design for manufacturability, Quality by Design (QbD) in the biotherapeutics or cell therapy industries
Experience in the use of statistical experimental design, data analysis and development of highly capable and robust manufacturing processes
Experience demonstrating understanding of current Good Manufacturing Practices (cGMP)
Experience demonstrating communication and project management skills to facilitate interactions with internal groups and with external collaborators and partners
Experience demonstrating organisational and interpersonal communication skills
Demonstrable ability to work in multi-disciplinary, multi-cultural teams
Why GSK?
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we’re making the biggest 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.​
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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.​
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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.​
*LI-GSK
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. 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.
At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.
GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record (http://fortherecord.payments.us.gsk.com/content/hcppaymenttransparency/en/hcppayments/payments.html) site.
We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have 3 global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. We aim to bring differentiated, high-quality and needed healthcare products to as many people as possible, with our scientific and technical know-how and talented people. We strive to attract the best people and to create an environment that empowers and inspires. Explore more exciting opportunities by visiting our career site (http://www.gsk.com/en-gb/careers/) .
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