- Provide technical support and oversight for ongoing commercial drug substance biopharmaceutical manufacturing
- Support efforts to continuously improve product yields and robustness, while improving COGS and product quality for products supplied by Rockville.
- Manage certain elements (such as upstream or downstream etc.) of the transfer of drug substance biopharmaceutical production technologies from R&D, third party clients or Contract Manufacturing Organisations to Rockville and from Rockville 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 Rockville
Why you? Basic Qualifications:
- Improvements to the existing supply chains supported by Rockville
- Lead technical oversight of manufacturing operations, facility changes and coordinating technical activities for specific products at Rockville.
- 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.
- Propose and implement process and yield improvements to existing commercial production at Rockville.
- Ensure technical accuracy of process documentation and related documentation for specific products. Responsible for ensuring that new technologies are properly validated in Rockville and that related regulatory documents to support licensing of specific products are prepared.
- Provide technical training to production staff for new equipment and process technologies as required.
- Support the introduction and possible scale-up of drug substance processes transferred from R&D or third party clients for specific products new within Rockville. Act as technical Rockville representative on the technology transfer teams and product development project team for specific products.
- Evaluate new technologies for GSK and define technology introduction strategies. Define long-term and near-term process improvements within area of expertise.
- Demonstrate the use of GPS (continuous improvement) tools and philosophies.
We are looking for professionals with these required skills to achieve our goals:
- Bachelors Degree in either biological or chemical science or engineering or equivalent technical discipline.
- A minimum of 3 years post-graduate experience in the Biopharmaceutical/pharmaceutical industry or equivalent with significant emphases on technology development and/or process technology transfer.
- Experience with current GMP's, NIH Guidelines and FDA and/or European validation practices for biopharmaceutical processes required.
If you have the following characteristics, it would be a plus:
- 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.
- Strong interpersonal and leadership skills.
- Strong verbal and written communication skills.
- Strong Analytical and critical thinking skills.
- Able to interact well with peers, subordinates, and senior personnel in scientific, quality, engineering and operational disciplines.
- Able to provide leadership to generate options to resolve problems, prioritise, and decide appropriate courses of actions. Effective at implementing decisions.
- Committed team player prepared to work in and embrace a team-based culture.
- Leadership potential.
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we're making the most significant changes we've made to our business in over 20 years.We're on track to separate and create two new companies in 2022:New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that isambitious for patients- so we deliver what matters better and faster;accountable for impact- with clear ownership of goals and support to succeed; andwhere we do the right thing. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.
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