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The Steely Group
http://www.thesteelygroup.com
http://www.thesteelygroup.com
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Sr. Associate
Posted: 04/14/2025
2025-04-14
2025-05-20
Employment Type:
Contract
Job Category: Scientific
Job Number: 4393
Job Description
As the candidate for this non laboratory-based position, you will be responsible for supporting technology transfer, process validation, and plant start-up.
You will work cross-functionally within North Carolina as you use process development experience to help drive efficient development and scalable understanding of processes.
Collaborate with other site-functions and network drug substance teams in delivering plant goals.
Requirements / Qualifications:
You will work cross-functionally within North Carolina as you use process development experience to help drive efficient development and scalable understanding of processes.
Collaborate with other site-functions and network drug substance teams in delivering plant goals.
Requirements / Qualifications:
- Master’s degree OR
- Bachelor’s degree and 2 years of experience OR
- Associate’s degree and 4 years of experience OR
- High school diploma / GED and 6 years of experience
- 2+ years proven experience in a technical role supporting biotechnology processes within regulated environments (i.e., cGMP).
- Knowledge in biologics purification processes.
- Experience in process scale-up, technology transfer and process validation.
- Able to apply engineering principles and statistical analysis in resolving complex issues.
- Knowledge in broad aspect of biologics processing, for example cell culture, analytical methods, or product quality attributes.
- Familiarity in operational aspects of commercial biopharma manufacturing (e.g. process automation, equipment, single use).
- Familiarity with Process monitoring tools such as PI, SIMCA.
- Written and verbal communication skills will be important to help draft protocols, reports.
- Demonstrate independence and ability to produce quality results under minimal direction.
- High energy individual who can multi-task and handle a fast-pace, dynamic work environment.
- Complete training on assigned tasks and comply with safety and compliance guidelines around process development activities.
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