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ALM Stability Manager

King of Prussia, Pennsylvania; Parma, Italy
Closing date
May 17, 2022

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Site Name: USA - Pennsylvania - King of Prussia, Italy - Parma Posted Date: May 12 2022 Are you energized by a scientific leadership role that allows you to enhance and improve processes across biopharmaceutical product development? If so, this ALM Stability Manager role could be an ideal opportunity to explore. The ALM Stability Manager is a strategic role and has the responsibility and accountability for ensuring that the product stability programs for biopharmaceutical products at PSC Upper Merion Biopharm site, Parma site and contract partners are successfully designed, implemented, and executed to support product shelf-life for non-clinical use, clinical use and commercial distribution. The Stability Manager administers the compliance of the group in reference to regulations, guidelines, procedures, and practices governing GMP stability. Responsible for strategy deployment of the stability programs. Other functions: reviews and approves, stability reports, technical reports; and authors and reviews stability modules for use in regulatory submissions (IND, IMPD, BLA, MAA). This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Provides leadership, manages performance of Stability Leads, develops performance plans, accurately assesses development needs to establish development plans in helping achieve objectives and enhancing performance and career advancement; coaches staff to achieve their full potential; leads and motivates staff to achieve individual and business goals Responsible for setting stability/ALM strategies and implementation of stability work processes in line with regulatory and business requirements Manages / oversees external contract organizations with respect to stability testing / reporting Review and approval of stability protocols and reports with oversight of regulatory data within the relevant CMC sections Responsible for GMP compliance in ALM Stability—specifically, oversees stability OOT/OOS and quality incident investigations and troubleshooting activities Support batch release including approving of certificates of analysis Interfaces with customers to assure customer satisfaction and accomplishment of group objectives Participates in BioPPD / MPD teams as ALM representative Interface with other groups (incl. BPS, RA, UMBL) on project related stability issues Participate in, and conduct GMP audits, PAIs, and due diligence as needed Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: BS Analytical Chemistry, Biology, Biochemistry 7-10 years relevant experience related to analytical competence, management of new products, regulatory filing, and team management. 5+ years strong experience with GMP stability program management in industry that supports both clinical and commercial biopharmaceutical products, with specific experience in writing regulatory submissions (IND,IMPD, BLA, MAA) and supporting regulatory inspections. Travel to Parma, Italy location 2-3 times a year Preferred Qualifications: If you have the following characteristics, it would be a plus: Strong experience with GMP stability program management in industry that supports both clinical and commercial biopharmaceutical products, with specific experience in writing regulatory submissions (IND,IMPD, BLA, MAA) and supporting regulatory inspections. Strong understanding of Statistical analysis as it pertains to stability data trending and product shelf life application. Strong verbal and written communication skills. Demonstrated supervisory and leadership skills. Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including biopharm development, QC, and QAFully versed in GMPs, ICH Guidelines, FDA, and other regulatory agency requirements for stability Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggest 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 #globalsupplychain 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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