Manufacturing Specialist I/II

KBI Biopharma, Inc.; Durham (NC); On-site; USD 60,000 - 78,000; Full time

Job summary

KBI Biopharma, Inc. in Durham, NC seeks a Technical Support Specialist for GMP Manufacturing Operations in a multi-product biopharma facility.

You will support downstream operations, draft manufacturing records, and act as SME to coach associates while driving process improvements on the shop floor. The role requires writing and routing batch records, supporting TRNs, deviations, and participation in Operational Excellence initiatives including 5S, Lean, and standardization.

Qualifications

• Demonstrated knowledge of downstream operations, cell culture and/or fermentation.
• Experience with single-use platform technology preferred.
• Bachelor’s degree in a related scientific or engineering discipline with 1+ year of GMP manufacturing experience or training.
• Requires minimal direction for routine tasks.
• Fluent in English with excellent written and verbal communication skills.
• Detail oriented, good time management and customer focus.

Responsibilities

• Provide technical support for GMP manufacturing operations in a multi-product facility.
• Draft, route and revise manufacturing batch records and procedures.
• Support new product/process introductions and changes, including facility fit and equipment modifications.
• Act as technical SME, coaching manufacturing associates and supporting trainers in TRN development.
• Support shop floor execution and manufacturing process improvements.
• Drive corrective and preventive actions and manage deviations in collaboration with QA.
• Contribute to Operational Excellence initiatives: 5S, Lean, standardization, and safety.

Skills

Downstream operations

Cell culture / fermentation

English communication

Education

Bachelor’s degree in related science/engineering

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.

Equal Employment Opportunity

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.

Company Culture

At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them.

We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one’s technical skills.

At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged.

Employment Terms

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me.

If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice.

I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed.

I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks.

If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.