Analytical Tech. Transfer Specialist
- 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.
- Thorough knowledge of cGMP requirements.
- Previous experience in Analytical Technology Transfer and Validation
- Familiarity with FDA/EU/ICH regulations and guidance particularly as they relate to Analytical Testing, Product Characterization, and Comparability Assessment.
- Independently applies knowledge in area of specialization to assignments that involve multiple decision points.
- Familiar with GLP regulations.
- Previous Biopharmaceutical experience.
- Supports department objectives in alignment with R&D 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 implementation of business processes and best working practices to ensure Analytical Technical Transfer operates strategically and as efficiently as possible.
- Contribute to the successful and timely transfer of BioPharm Analytical methods/technologies to and from R&D development, contract manufacturer's, testing labs, or GSK commercial manufacturing organizations.
- Effectively prioritizes activities to meet project or department objectives using demonstrable project management skills.
- May lead matrix or small teams.
- 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.
- Independently authors, internal reports, protocols, policies/plans or regulatory submissions.
- Presents effectively to internal R&D forums and may present results at external meetings.
- Keeps manager and matrix team leaders informed of progress and activities.
You may apply for this position online by selecting the Apply now button.
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