Stability Program Lead
Site Name: USA - Pennsylvania - King of Prussia Posted Date: Jul 6 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 non-clinical use, clinical use 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 rationales and protocols (LES, CLS, CDMS), stability reports, technical reports, shelf life reports, project plans, and stability SOPs for biopharmaceutical drug candidates 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, Drug Product, Reference Standards, SA, and CTM material expiration Tracking and trending of release and stability data Authors stability modules for use in regulatory submissions (IND, IMPD, BLA, MAA) 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: Bachelors Degree in a related Science field 1+ year 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: 2-3+ 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. 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