The GSK Consumer Healthcare R&D team
supports the development of leading global brands in Consumer Health care
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:
Why you? Basic Qualifications :
- 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
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
If you have the following characteristics it would be a plus:
Why Consumer Healthcare?
- 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
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.
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