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Associate Director, Analytical Industrialization Leader
Location:
Cambridge, MA
Description:
Within the Analytical R&D group, the Analytical Industrialization Leader (AIL) is in charge of defining and leading the implementation of best-in-class, phase appropriate and breakthrough analytical lifecycle approaches and novel strategies allowing implementation in commercial QC, in alignment with the GSK Vaccines R&D and TRD strategies, and in accordance with guidanceThis role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Define and lead the implementation of best-in-class, phase appropriate and breakthrough analytical lifecycle approaches i.e. novel strategies allowing faster analytical validation (e.g. validation during development, at & on-line testing, ...), enhanced management of assay performances, management of reference standards and reagents and novel strategies allowing implementation (transfer) in commercial QC. Support the analytical platforms from ARD for the deployment and actual application of these strategies to novel products in the R&D pipeline. Participate actively to interactions with Health Authorities during file submissions, consultations and inspections. Coach Analytical R&D development scientists and Analytical Product Leaders while creating a network of SMEs. Engage with internal stakeholders (Quality, Regulatory, Commercial QC, TDLs, APLs and peer TRD function Heads) to ensure alignment of long-term goals, effective collaborations and successful project outcomes. Accountable for compliance, harmonization and improvement of ARD SOP(s) related of analytical method qualification and validation, method transfer, analytical method comparability, reference material and reagents and analytical method lifecylcle (SST, invalid rules,...); and with QC Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Master's degree in chemistry, Biology, Biochemistry, Pharmaceutical Sciences, or related scientific field. 10+ years of experience in the pharmaceutical industry in the analytics for biologics (analytical development, product characterization or Quality Control of recombinant proteins, monoclonal antibodies, fusion proteins, conjugates and/or vaccines drug candidates. Experience in pharmaceutical laboratory techniques to interact efficiently with analytical and pharmaceutical processes and regulatory and GMP requirements. Preferred Qualifications: If you have the following characteristics, it would be a plus. Ph.D. or equivalent in biological, analytical, or pharmaceutical sciences, or similar field. Reliable individual, with strong managerial skills; ability to influence at all levels of the organization and externally. Ability to communicate across all organizational levels. Customer focused; ability to understand requirements of QC stakeholders Strong presentation skills. Good understanding of vaccines or similar biologics controls and manufacturing (primary and secondary operations) as well as raw material manufacturing technologies. Good knowledge of quality and risk management principles and tools. Flexible, proactive thinking. Passion for improvements. Ability to adapt, work under uncertainty and accommodate flexible work demands. Global perspective; cultural sensitivity Recognized as expert within GSK (GMS and Vaccines) for analytical methods lifecycle. #LI-GSKPlease visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.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-XXXX (US Toll Free) or +1 801 567 XXXX (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. 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.PDN-9beda2c1-27a2-400e-a62d-58bcda446b83
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More About this Listing: Associate Director, Analytical Industrialization Leader
Associate Director, Analytical Industrialization Leader is a Executive Associate Director Job at GSK located in Cambridge MA. Find other listings like Associate Director, Analytical Industrialization Leader by searching Oodle for Executive Associate Director Jobs.
Associate Director, Analytical Industrialization Leader is a Executive Associate Director Job at GSK located in Cambridge MA. Find other listings like Associate Director, Analytical Industrialization Leader by searching Oodle for Executive Associate Director Jobs.