Manage certain elements (such as upstream or downstream etc.) of the transfer of primary(drug substance) biopharmaceutical production technologies from R&D, third party clients or Contract Manufacturing Organizations to GMS Biopharm and from GMS Biopharm to other biopharmaceutical manufacturing sites.
Support delivery of new biopharmaceutical applications and technologies as well as on delivering improvements to the existing supply chains supported by GMS Biopharm and technology transfers between GMS Biopharm & R&D.
Support efforts to continuously reduce product COGS while improving product quality for products supplied by GMS Biopharm.
Support the introduction and possible scale-up of primary(drug substance) processes transferred from R&D or third party clients for specific products new within GMS Biopharm. Support establishing resource requirements necessary to implement approved projects.
Act as technical GMS Biopharm representative on the technology transfer teams and product development project team for specific products. Responsible for managing the relationship between R&D or third party clients and GMS Biopharm for specific products and if needed influence decision makers within R&D or third party clients.
Propose strategies and priorities in planning technical transfer/process validation activities within area of expertise.
Responsible for process trend analysis and assurance that processes remain within control parameters. Responsible for resolving process issues/ problems in a manner and timeframe consistent with production and quality goals for specific products.
Provide technical training to production staff for new equipment and process technologies as required.
Evaluate new technologies for GSK and define technology introduction strategies. Define long-term and near-term process improvements within area of expertise.
Ensure technical accuracy of process documentation and related documentation for specific products. Responsible for ensuring that new technologies are properly validated in GMS Biopharm and that related regulatory documents to support licensing of specific products are prepared.
May need to contribute to technical oversight of manufacturing operations, facility changes or coordinating technical activities for specific products at GMS Biopharm.
Contribute to evaluations of potential fit of prospective new products into GMS Biopharm (e.g. SIA's RFI responses)
Demonstrate the use of OE/GPS tools and philosophies.
Why You?Basic qualifications:
BSc/BA in either biological or chemical science or engineering or equivalent technical discipline.
5 years' experience in the Biopharmaceutical/pharmaceutical industry or medical device with significant emphases on technology development and/or process technology transfer.
Biopharmaceutical industry experience
Knowledge of current GMP's, NIH Guidelines and FDA and/or European validation practices for biopharmaceutical processes required.
Why GSK? Because GSK's BioPharm business vision is to leverage its experience and technical capabilities to launch, supply, and manage Biopharmaceutical products around the world. It will fulfill GSK's Mission to Do More, Feel Better, and Live Longer by living its values: Integrity: Always doing the right thing; Commitment to the Patient: Making the Patient the #1 Priority; Customer Service: Commit to delivering on promises to internal & external customers; Compliance Being accountable for quality and safety.
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