Senior Manufacturing Specialist

KBI Biopharma • Durham, NC

7d • Onsite

About The Position

Responsible for leading technical support activities for GMP Manufacturing Operations in a multi-product, large scale, biopharmaceutical facility.

Requirements

• Bachelor’s degree in a related scientific or engineering discipline preferred with 6+ year’s related experience and/or training; or equivalent experience
• Requires minimal direction or supervision to execute against routine tasks.
• Fluent in English with excellent written and verbal communication skills are required.
• Must be detail oriented, have good time management skills and be customer focused
• Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.

Nice To Haves

• Demonstrated knowledge of downstream operations is preferred, cell culture and/or fermentation
• Experience in single-use platform technology is preferred

Responsibilities

• Facility Fit support
• Manufacturing Record and procedure drafting
• Equipment procurement or modification
• Training generation
• Drafting, routing, and revision of manufacturing batch records, procedures, supporting records.
• Serve as technical SME in manufacturing operations, coaching and mentoring manufacturing associates, supporting trainers in development of TRNs
• Manufacturing process support during on-going shop floor execution.
• Engage with Manufacturing Associates and Supervisors to understand barriers to success, identify opportunities for improvement. Drive and manage projects with significant process improvement impact
• Lead implementations for corrective and preventive actions. Partner with Compliance/QA for timely Deviation Investigation completion
• Support activities associated with Operational Excellence Initiatives including: Error Proofing, Standardization, 5S, Lean Manufacturing
• Support safety initiatives, compliance & quality requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior