As a technology associate, you would be responsible to support the management of certain elements (upstream, downstream, etc.) of the transfer of primary (drug substance) biopharmaceutical production technologies from R&D, third party clients, or contract manufacturing organizations to the Upper Merion Manufacturing site and from Upper Merion to other biopharmaceutical manufacturing sites. Support the delivery of new biopharmaceutical applications and technologies as well as improvements to the existing supply chains supported by the Upper Merion Manufacturing site and technology transfers between Upper Merion & R&D. Assist in efforts to continuously reduce product COGS while improving product quality for products supplied by Upper Merion.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
- Determine adequacy of plant to accept new technologies, implement plans to achieve adequacy and take appropriate actions to implement start of new process operations.
- Responsible for development and preparation of technology transfer/process validation protocols and "hands-on" startup of production processes with operators. Support technical training of production staff for new equipment and process technologies as required.
- Responsible for preparation and presentation of technology transfer/process validation reports or other technical documentation.
- Define training program for operators as part of technology transfer and when required train process operators.
- Take leadership in identifying potential process problems, provide technical advice to Production and/or Quality Assurance departments to resolve process problems.
- Identify areas of improvements during technology development and/or technology transfer. Advise management as to possible opportunities for process improvements.
- Collect and track process trend data and monitor process trends. Determine causes of process variances and recommend corrective actions.
- Stay current with developments in the fields of biotechnology and bioprocessing. Support evaluation of new technologies for GSK and technology introduction strategies.
- May need to contribute to technical oversight of manufacturing operations or coordinating technical activities for specific products at Third Party sites for Upper Merion.
- Demonstrate the use of Operational Excellence/Lean Six Sigma tools and philosophies.
We are looking for professionals with these required skills to achieve our goals:
- BS/BA in either biological or chemical science, biological or chemical engineering, or an equivalent technical discipline.
- Or 5+ years or experience in Biopharmaceutical / pharmaceutical industry or equivalent in lieu of education.
- 3+ years experience in the Biopharmaceutical/ pharmaceutical industry or equivalent.
- 3+ years of experience with GMPs, NIH Guidelines and FDA and/or European validation practices for biopharmaceutical processes
If you have the following characteristics, it would be a plus:
- M.S. in either biological or chemical science or engineering or equivalent technical discipline
- Knowledge in biopharmaceutical technologies such as large scale cell culture technology, biopseparation technologies, or pharmaceutical manufacturing of proteins. Basic understanding of analytical technologies related to the above.
- Prior experience in technology development and/or process transfer preferred.
- 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 priorities, and decide appropriate courses of actions. Effective at implementing decisions.
- Committed team player prepared to work in and embrace a team-based culture.
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggest 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 is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership of goals and support to succeed; and where 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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