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Investigator Cell and Gene Therapy, Analytical Development, Cell Analytics

Employer
GSK
Location
Collegeville, Pennsylvania
Salary
Competitive
Closing date
May 17, 2022
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Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage Posted Date: Apr 1 2022 Are you energized by the challenge of shaping and developing analytical methods to accelerate getting medicines to patients faster? If so, this investigator role in Cell & Gene Therapy, analytical development CMC could be an exciting opportunity to consider! GlaxoSmithKline is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to support our mission 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, as well as the development of innovative technologies to enable step-change improvements to cell and gene therapy manufacture. GSK has a significant collaboration in the T cell immunotherapy field with Adaptimmune and other licensing/partnership opportunities are being pursued. The progression of our own portfolio together with the maturation of emerging gene therapy technologies creates an imperative for GSK to now increase our investment in this space and establish an end to end leading platform. This will facilitate delivery of the portfolio in Oncology as well as ensuring that GSK is able to capture the potential of the emerging technologies in other therapeutic areas. A key CMC challenge in this endeavour is the development of suitable analytical methods that can support both process development and manufacturing of cell and gene therapy products. The successful candidate will join an analytical development group that is currently expanding in the UK and USA. Key Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Development of analytical methods and method transfer to internal Product Development, QC laboratories, and CMOs or testing laboratories. Support establishing internal laboratories for analytical testing for T-cell therapy products. Responsible for successful interactions with contract manufacturing at third party manufacturers and testing laboratories. The role requires significant external engagement with 3rd parties (contractors, suppliers, testing laboratories, academic and industry groups). Support external collaborations to enhance our analytical capabilities and enable the future vision of a robust and rapid testing strategy for cell and gene therapy products. Participate in risk assessments to develop robust product control strategies for cell & gene therapy programmes. Maintenance of laboratory equipment and critical reagents including analytical method control preparation and maintenance. Own and manage the analytical method lifecycle during product development, including risk assessments and preparation of qualification reports. Support capability build in other functional areas as needed. Why you? Basic Qualifications We are looking for professionals with these required skills to achieve our goals: BSc/MSc degree (or equivalent) in a relevant life science discipline. Preferred Qualifications If you have the following characteristics, it would be a plus: PhD degree as preferred qualification with extensive experience in cell biology, immunology, or related scientific discipline. Experience working with 3rd parties and developing/maintaining working relationships with these partners. Experience in preparing oral and technical reports to influence strategic decisions. Industrial experience in cell culture and multi-colour flow cytometry panel design (minimum 5 years experience). Experience in the development of cell-based methods for producing and analysing primary, mammalian cell lines and T-cells and the characterization of these cells by flow cytometry. Strong organisational and excellent interpersonal communication skills. Ability to work independently, proactively seeking solutions for problem solving, within a matrix team environment. Familiarity with basic statistics and troubleshooting of out of specification/trend results. 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. 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. *LI-GSK #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 site.
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