Senior Technology Associate
Are you energized by a technical role that allows you to accelerate compliance and shape product quality? If so, this Senior Technology Associate role could be an ideal opportunity to explore.
As a Senior Technology Associate, you will be responsible to support managing 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 UM Biopharm and from UM 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 UM Biopharm and technology transfers between UM Biopharm & R&D. Assist in efforts to continuously reduce product COGS while improving product quality for products supplied by UM Biopharm
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 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 UM Biopharm.
- Demonstrate the use of 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 at least 10+ years experience in Biopharmaceutical/ pharmaceutical industry or equivalent in leu of education
- 4+ years post-graduate experience in the Biopharmaceutical/ pharmaceutical industry or equivalent
- 4+ years of experience with 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:
- Knowledge in biopharmaceutical technologies such as large scale cell culture/microbial technology, biopseparations 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.
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.
At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.
GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.
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