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Stability Associate Scientist

Richmond, VA
Closing date
May 17, 2022

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Physical Sciences, Chemistry
Job Type
Staff Scientist
Organization Type
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Site Name: Richmond Sherwood Posted Date: May 9 2022 GSK Consumer Healthcare R&D supports the innovation and development of leading global brands in Consumer Healthcare. Stability Sciences is a specialized discipline that contributes to the growth of the business by providing for the assignment of shelf life and label storage conditions. R&D Stability leads in developing strategies, designing and executing stability studies, evaluating data, and issuing technical stability reports. The Stability Associate Scientist collaborates within the Stability Team and with other business functions to deliver on the stability study activities within project timelines. The Stability Associate Scientist is responsible for the coordination of stability studies including sample incubation to sample pull and delivery, sample inventory and disposal, assisting with data management and data evaluations, and operations of the stability chambers. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Conduct stability-related chamber operational activities to support R&D product development (formal and informal studies). Ensure that the stability facilities are maintained in a compliant state and manage stability samples in the chambers. Serve as a primary point-of-contact for stability chamber alarms, which involves collaborating across multiple functions to routinely monitor stability chambers for operational performance (i.e., temperature / humidity / light control), address, and report threshold alarms as per site procedures. Prepare and issue quarterly data reports tracking the performance / operation of the stability chambers. Coordinate and track chamber preventative maintenance, calibration, and qualification activities with respective technical experts. Work within team to perform daily inspections of the Stability Facility. Under guidance from the Stability Team Leader, use quality systems to issue change controls and deviation. With minimum supervision, develop procedures, work instructions, and operational guidelines. Support stability facility operation activities related to internal and/or external audits. Work with Stability Managers and Stability Scientists to prepare and execute stability study incubation activities (i.e., scheduling, reviewing documentation, labeling samples, incubating samples, pull & delivery, external shipment). For external testing, ship samples which includes the completion of necessary paperwork and tracking of delivery status. Upon completion or discontinuation of a stability study, process necessary paperwork and system activities, and dispose of the samples as per site procedure. Assist with the development and finalization of stability study protocols,expiry memos, and other technical documents. Utilize a laboratory information management system (e.g., LabWare LIMS) to create and initiate stability protocols. Review stability data and assist in recommending/confirming shelf life support human use studies (i.e. sensory/clinical) and commercial launches. Assist with data trending / analysis and apply sound scientific rational in establishing expiry periods. Work cross functionally and in close collaboration with Quality, Product Development, and Analytical teams to ensure that stability deliverables are met within the timeline and are in compliance. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's Degree in Chemistry, Biology, Microbiology, Data Science, Statistics, Applied Mathematics Preferred Qualifications: If you have the following characteristics, it would be a plus: Experience in pharmaceutical or consumer healthcare industry, experience in a stability program is preferable Preferred general understanding of the drug development process. Experience working directly in stability program within the pharmaceutical industry. Knowledge of ICH/WHO and other stability guidelines. Good awareness of cGMP guidelines Preferred experience in a laboratory information management system (e.g., LabWare LIMS), statistical software (e.g. Statistica, Minitab, JMP, SAS). Why Consumer Healthcare? Right now, we're on an incredible journey as we prepare to become the first independent, 100% focused consumer healthcare company. We're doing this at a time when the work we do has never mattered more. Better everyday health is about improving the health and wellness of the consumers that we touch every year - over a billion and a half of them - and it goes beyond products. It's about truly helping people manage their health proactively in different ways as consumer needs evolve. With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we're uniquely placed to do this and to grow a strong, successful business. This is an exciting time to join us and help shape the future. It's an opportunity to be part of something special. Diversity, Equity and Inclusion In Consumer Healthcare we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. *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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