Senior Technology Associate
- King of Prussia, PA
Site Name: USA - Pennsylvania - King of Prussia
Posted Date: May 29 2020
Are you energized by a technical role that allows you to accelerate compliance and shape quality? If so, this Sr Technology Associate role could be an ideal opportunity to explore.
As a Sr Technology Associate, you will support the management of certain elements of the transfer of primary 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.
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.
- Responsible for preparation and presentation of technology transfer/process validation reports or documentation
- Define training program for operators as part of technology transfer and when required train process operators.
- Take leadership in identifing potential process problems, provide technical advice to Production and/or Quality Department 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 co-ordinating technical activities for specific products at Third Party sites for GMS Biopharm.
- Demonstrate the use of OE/GPS tools and philosophies.
We are looking for professionals with these required skills to achieve our goals:
- BS/BA in either biological or chemical science or engineering or equivalent technical discipline or alternatively at least 10 yrs experience in Biopharmaceutical/ pharmaceutical industry or equivalent.
- A minimum of 5 years post-graduate experience in the Biopharmaceutical/ pharmaceutical industry or equivalent.
- Knowledge of current GMP's, NIH Guidelines and FDA and/or European validation practices for biopharmaceutical processes
If you have the following characteristics, it would be a plus:
- Prior experience in technology development and/or process transfer.
- Strong interpersonal and leadership skills.
- Strong verbal and written communication skills.
- Strong Analytical and critical thinking skills.
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.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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