We are building a state-of-the-art end to end Biopharm capability which delivers efficient discovery of antibody molecules that are selected and engineered for rapid development so that, together with our therapy area partners, we discover, develop and manufacture novel portfolio of exciting medicines to benefit patients around the world. If you aim to be part of a global cutting edge drug development and discovery organization and are motivated to contribute towards bringing lifesaving drugs to patients, join us! Click here to know more about GSK Biopharm. #GSKBiopharm_Development The Associate Director, Stability, SED will be responsible to: Provide direction and expert knowledge in stability programs. Collaborate with Drug Substance, Drug Product, Analytical Development SMEs, Quality and CMC Regulatory Affairs to design and oversee execution of stability programs for small and large molecule drug substances, oral and sterile drug products, to support investigational drug and marketing applications, technology transfer, scale up and manufacturing process comparability. Ensure that stability programs address regulatory filing requirements for multiple climatic zones and countries. Oversee tracking and trending of stability data. Perform statistical analyses to provide shelf-life projections, support proposals for end-of-shelf-life product specifications, monitor performance of stability batches and meet regulatory reporting requirements, using statistical analysis software. Support submission deliverables, including authoring and review of stability and reference standard sections from INDs/IMPDs, BLAs/MAAs and health agency information requests. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: BS in Chemistry, Biochemistry, Pharmaceutical Sciences, Engineering, Materials Science or related scientific discipline with 10+ years of pharmaceutical industry experience or MS/PhD in Chemistry, Biochemistry, Pharmaceutical Sciences, Engineering, Materials Science or related scientific discipline required with 8+ years of experience Experience with GMPs, ICH guidelines, USP, PhEur Regulations Experience with statistical analysis software Experience leading people, managing projects and working with cross-functional teams comprised of internal and/or external contacts Preferred Qualifications: If you have the following characteristics, it would be a plus: Experience providing leadership and technical oversight of stability programs Experience establishing and managing a reference material and critical reagent program Experience building relationships and working with CMOs Experience with global regulatory submissions (Japan, China, Brazil, etc.) Experience with establishment and/or management of reference material and critical reagent program. Why GSK? Uniting science, talent, and technology to get ahead of disease together At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we're making the most significant 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 GSKBiopharm_development 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. 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