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Associate Director, Stability, SED

Waltham, MA
Closing date
May 17, 2022

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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. 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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