Investigator - Analytical Lifecycle Management

King of Prussia, Pennsylvania; Rockville, Maryland
July 07 2021
Organization Type
Site Name: USA - Maryland - Rockville, USA - Pennsylvania - King of Prussia Posted Date: Jul 7 2021 As an Investigator - Analytical Lifecycle Management, you will be responsible for building and enhancing biopharmaceutical expertise to be further embedded in the business. This role will provide YOU the opportunity to lead key activities to progress your career. These responsibilities include some of the following... Contribute to the implementation of business processes and best working practices to ensure Analytical Lifecycle Management operates strategically and as efficiently as possible Independently authors internal reports, protocols, policies/plans or regulatory submissions Supports department objectives in alignment with project objectives Anticipates and recognizes potential problems, initiates actions to solve or prevent problems and communicates issues/risks to project lead and manager Contribute to the successful and timely transfer, validation and oversight of BioPharm Analytical methods/technologies to and from R&D development, contract manufacturer's, testing labs, or GSK commercial manufacturing organizations (Product Supply Chain) Effectively prioritizes activities to meet project or department objectives using demonstrable project management skills May lead a project, matrix team or small focus groups Plays a significant part in the project team decision making process Consistently exhibits professionalism and courtesy and may serve as a representative of GSK to business partners and contract organizations Presents effectively to internal R&D and PSC forums and may present results at external meetings Keeps manager and matrix team leaders informed of progress and activities Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's Degree in Biochemistry, Chemistry or Biology and at least 5 years Analytical Technology Transfer and Validation experience OR a Ph.D./MS degree in Biochemistry, Chemistry or Biology and at least 3 years Analytical Technology Transfer and Validation experience Preferred Qualifications: If you have the following characteristics, it would be a plus: Thorough knowledge of cGMP requirements Previous experience in Analytical Technology Transfer and Validation for biopharmaceuticals Familiarity with FDA/EU/ICH regulations and guidance particularly as they relate to Analytical Transfer and Validation, Critical Quality Attributes, and Release and Stability Testing Independently applies knowledge in area of specialization to assignments that involve multiple decision points Familiar with GLP regulations Previous Biopharmaceutical experience 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. 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