This job has expired

Stability Manager, R&D Consumer Health

Employer
GSK
Location
Richmond, VA
Salary
Competitive
Closing date
May 22, 2022

View more

Discipline
Other, Other
Job Type
Manager, Research Scientist
Organization Type
Pharma
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Site Name: Richmond Sherwood Posted Date: May 19 2022 The GSK Consumer Healthcare R&D team supports the development of leading global brands in Consumer Health care. Stability sciences is a specialized discipline providing support for to new product development and product optimizations contributing to the growth of the Consumer Health Business. Their expertise is utilized by providing technical data supporting product stability within assigning shelf life and storage conditions. The Stability Manager, R&D Consumer Health role requires close collaboration with Quality, Regulatory, Packaging and Product Development teams to ensure that technical data and documentation generated by Stability function meets the timeline and compliance. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Serve as Subject Matter Expert on multiple new product development project teams and provide guidance regarding stability regulations Ensure that stability aspects of new products and product optimizations are assessed, reviewed and maintained throughout all development phases Design stability strategies with consideration to meet global market requirements and regulatory guidelines (i.e. ICH/WHO). This includes design stability protocols for registration/ pivotal, In Use, Photostability, Bulk Stability, and Freeze Thaw/High Temperature stability studies Proficient in LIMS or equivalent system to create and initiate stability protocols Review of stability data to confirm expiry/shelf life support human use studies (i.e. sensory/clinical) to commercial launch and alerts project development team as appropriate Utilize data analysis and sound scientific rational to establish expiry periods. Proficient in trend analysis using statistical software Prepare documentation of trend analysis reports, and stability summary reports for regulatory submission (3.2.P.8 sections) Confirms atypical and/or out of specification (OOS) results and participate in product investigation by applying root cause analysis and implementing effective CAPAs Develops strong, collaborative relationships with outsourced partner to help facilitate completion of external Stability activities Maintain awareness of global regulations that impact stability Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's Degree (Analytical Chemistry preferred) 10 + years experience in Pharma Science or related field 2 + years experience in the area of stability science within the pharmaceutical industry Experience with the drug development process with a diverse product experience including registered and monograph drugs, medical devices, dietary supplements, cosmetics and foods Experience and knowledge of ICH/WHO and other stability guidelines Experience working directly in stability program within the pharmaceutical industry Experience using LIMS (equivalent), Statistical software (i.e. Statistica/Minitab) Microsoft PowerPoint, Project, Word, Excel Preferred Qualifications: If you have the following characteristics it would be a plus: Masters or PhD Degree Solid awareness of cGMP guidelines Excellent written and oral communication skills, ability to work well with others Able to interact effectively with the most senior levels of management both internally and externally Ability to multi-task and adapt to changing business requirements in a fast- paced environment. Strategic planning and quick decision-making skills to meet timely organizational goals Proven ability to express problems / challenges and solutions in a clear and concise manner Strong understanding of stability study structure and managing stability chambers Proven ability to successfully manage teams across time zones and cultures 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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