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:

• 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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