Investigator - Analytical Technology Transfer
- King of Prussia, PA
Site Name: USA - Pennsylvania - King of Prussia
Posted Date: Jan 30 2020
As an Investigator - Analytical Technology Transfer, 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 Technical Transfer 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 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 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
If you have the following characteristics, it would be a plus:
- 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 Release and Stability 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.
Our values and expectationsare 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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