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Stability Program Lead

King of Prussia, Pennsylvania; Rockville, Maryland; Collegeville, Pennsylvania
Closing date
Dec 10, 2021

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Other, Other
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Site Name: USA - Pennsylvania - King of Prussia, USA - Maryland - Rockville, USA - Pennsylvania - Upper Providence Posted Date: Dec 7 2021 As a Stability Program Lead, you have the responsibility and accountability for developing and managing product stability programs for biopharmaceutical products in PSC Upper Merion Biopharmaceutical site to support product shelf-life for PPQ and commercial distribution. Each stability lead will be accountable for multiple biopharmaceutical assets. The Stability Lead is accountable to comply with requirements in reference to regulations, guidelines, procedures, and practices governing GMP stability. Responsible for strategy deployment of the stability programs. This role will provide you the opportunity to lead key activities to progress your career, these responsibilities include some of the following… Primary responsibilities include authoring and approval of stability protocols (LES, CLS, Veeva), stability reports, technical reports, shelf life reports, project plans, and stability SOPs for biopharmaceutical drugs Represent ALM as the stability lead on Matrix teams to define lifecycle appropriate stability strategies, review real time data for trends, and agree objectives and timings Statistical trending of analytical data for assay capabilities and shelf-life evaluation Tracking of Drug Substance and Drug Product PPQ and commercial material expirations Tracking and trending of release and stability data Authors stability modules for use in regulatory submissions (BLA, MAA, SLE) including preparation and review of data which includes stability data tables, protocols, and commentary Interface with and provide GSK oversight for contract testing laboratories including review of data, lab investigations, change controls, etc. Maintain data in audit-ready state and performs data compliance / verification checks Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor Degree in a related Science field 2+ years of experience functioning as a Program Stability Lead Experience with cGMPs and biopharmaceutical manufacturing processes Experience with ICH / WHO stability requirements Ability to travel up to 20% (domestic and international) Preferred Qualifications: If you have the following characteristics, it would be a plus: 3+ years of experience functioning as a Program Stability Lead Strong understanding of statistical analysis as it pertaining to stability data trending and product shelf life application Ability to work effectively as an individual contributor and as a team member within a matrix environment Ability to work with diverse customer base (internal and external) Excellent verbal and written communication skills Strong interpersonal skills and behaviors Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution Continuously looking for opportunities to learn, build skills and share learning Sustaining energy and well-being Building strong relationships and collaboration, honest and open conversations Budgeting and cost-consciousness 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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