Stability Program Lead
- King of Prussia, PA
Site Name: USA - Pennsylvania - King of Prussia
Posted Date: Feb 5 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 Biopharm site to support product shelf-life for non-clininal use, clinical use and commercial distribution. Each stability lead will be accountable for multiple biopharm 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 biopharm 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.
- Facilitation of Stability Matrix teams
- 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 includies 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
- At least 3 years of relevant experience
If you have the following characteristics, it would be a plus:
- 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 communication skills including technical writing abilities and in depth knowledge of cGMPs, biopharmaceutical manufacturing processes is required
- Strong interpersonal skills and behaviors
- Familiar with ICH / WHO stability requirements
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.
*This is a job description to aide in the job posting, but does not include all job evaluation details.
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