Manufacturing Specialist I/II

NCBioImpact; Durham (NC); On-site; USD 60,000 - 80,000; Full time

Job summary

KBI Biopharma, Inc. in Durham, NC, is hiring for a GMP Manufacturing Support role focused on downstream operations and batch record management.

You will act as a technical SME for manufacturing processes, coaching shop floor staff and assisting in TRN development and training delivery. The role requires experience in cell culture/fermentation, familiarity with single-use platforms, and a degree in a related field or equivalent GMP manufacturing background.

Qualifications

• Knowledge of downstream operations, cell culture and/or fermentation.
• Experience with single-use platform technology is preferred.
• Bachelor's degree in a related scientific or engineering discipline preferred with 1+ year related experience and/or training; or equivalent GMP manufacturing experience.
• Requires minimal direction or supervision to execute routine tasks.
• Fluent in English with excellent written and verbal communication skills.

Responsibilities

• Perform New Product/Process Introduction and Changes including Facility Fit support.
• Draft, route, and revise manufacturing batch records, procedures and supporting records.
• Serve as technical SME in manufacturing operations and coach associates; support trainers in TRN development.
• Provide manufacturing process support during ongoing shop floor execution.
• Engage with Associates and Supervisors to identify barriers and drive improvement projects.
• Lead CAPA implementations and partner with Compliance/QA for Deviations investigations.
• Support Operational Excellence initiatives including 5S, Lean Manufacturing, and standardization.
• Support safety, compliance and quality requirements.

Skills

Downstream operations

Cell culture

Fermentation

Single-use platform

Communication skills

Education

Bachelor's degree or equivalent GMP experience

Job description

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

Job Responsibilities

• New Product/Process Introduction and Changes including:
  • 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 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.

Minimum Requirements

• Demonstrated knowledge of downstream operations, cell culture and/or fermentation
• Experience in single-use platform technology is preferred
• Bachelor's degree in a related scientific or engineering discipline preferred with 1+ year's related experience and/or training; or equivalent GMP manufacturing 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.

Working Conditions

The job requires supporting a 24-hour manufacturing facility which may include on call phone support or support overnight and on weekends. The job requires working within a cGMP manufacturing biotechnology facility which requires clean room operations. Clean room operations require donning clean room attire when entering clean room areas and maintaining good personal hygiene. While performing the duties of this job the employee may use equipment and materials which include mechanical hazards, chemical hazards, electrical hazards, and tripping and falling hazards. The noise level in the manufacturing environment is moderate to high, however, employee will routinely work in office area.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.