Product Technology Manager

Your Responsibilities:  Job Description Summary-o 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 Organisations to GMS Biopharm and from GMS Biopharm to other biopharmaceutical manufacturing sites.  o 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. o Support efforts to  continuously reduce product COGS while improving product quality for products supplied by GMS Biopharm. Key Responsibilities  o 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. o 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. o Propose strategies and priorities in planning technical transfer/process validation activities within area of expertise. o 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. o Provide technical training to production staff for new equipment and process technologies as required. o Evaluate new technologies for GSK and define technology introduction strategies.  Define long-term and near-term process improvements within area of expertise. o 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. o May need to contribute to technical oversight of manufacturing operations, facility changes or co-ordinating technical activities for specific products at GMS Biopharm. o Contribute to evaluations of potential fit of prospective new products into GMS Biopharm (e.g. SIA's RFI responses) o Demonstrate the use of OE/GPS tools and philosophies. Why You? Basic qualifications:  o A minimum of 5 years post-graduate experience in the Biopharmaceutical/pharmaceutical industry or equivalent with significant emphases on technology development and/or process technology transfer. o Knowledge of current GMP's, NIH Guidelines and FDA and/or European validation practices for biopharmaceutical processes required. Preferred qualifications:  o Expert knowledge in biopharmaceutical technologies including large scale cell culture/microbial technology, biopseparations technologies, and pharmaceutical manufacturing of proteins.  Understanding of analytical technologies related to the above. o Strong interpersonal and leadership skills.   o Strong verbal and written communication skills. o Strong Analytical and critical thinking skills. o Able to interact well with peers, subordinates, and senior personnel in scientific, quality, engineering and operational disciplines. o Able to provide leadership to generate options to resolve problems, prioritise, and decide appropriate courses of actions.  Effective at implementing decisions. o Committed team player prepared to work in and embrace a team-based culture. o Leadership potential. Requisition ID: WD184608
Salary Range: NA
Minimum Qualification
5 - 7 years

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