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Senior Scientist, Microbiology and Sterility Assurance

Employer
GSK
Location
King of Prussia, Pennsylvania
Salary
Competitive
Closing date
May 30, 2022

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Sector
Science, Pharmaceutical
Organization Type
Corporate
Jobseeker Type
Professional
Site Name: USA - Pennsylvania - King of Prussia Posted Date: Apr 12 2022 Are you interested in being a key member of a Microbiology, Systems and Analytical Services (MSAS) team that is responsible for supporting the Manufacturing Process of sterile filling operations for both small and large molecule R&D clinical supplies? If so, this role might just be for you. As a Senior Scientist on the Microbiology team supporting sterility assurance and Microbiology testing for a R&D Sterile Manufacturing facility, this role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Achieve and maintain Grade B gown qualification status in the sterile facility. Provide direct Microbiological support and oversight for aseptic process simulations and sterile filling operations. Provide sterility assurance support to the R&D Sterile Manufacturing facility for all product, people and material processes related to contamination control. Recognize, communicate and lead investigations of aberrant microbiological test results or trends Write microbiological methods and SOPs regarding sterility assurance where required Perform, Microbiological Quality Control activities, including: Environmental monitoring to support non-sterile and sterile areas and operations personnel Aseptic sampling and testing of pharmaceutical water system samples Routine bioburden testing on raw materials and finished product, e.g., microbial enumeration, sterility testing, selected species testing Bacterial endotoxin testing on pharmaceutical water system samples, raw materials and finished products Identifications of microbial isolates Approving test results that support release of finished products and stability programs Why you? Basic Qualifications: Bachelor's degree in Microbiology, Biology, Immunology, Biotechnology or related majors Preferred Qualifications: Master's degree in Microbiology, Biology, Immunology, Biotechnology or related majors At least 3 years practical laboratory experience Demonstrates good communication skills Has ability to work effectively with a team and able to work independently Recent experience in aspects of sterility assurance including gowning and investigations Has knowledge of cGMP requirements and ability to generate high quality data Has some computer application experience (i.e., database use and management) Demonstrated proficiency using Labware LIMStm or similar electronic documentation databases 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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