Senior Manufacturing Specialist

KBI Biopharma, Inc.; Durham (NC); On-site; USD 110,000 - 140,000; Full time

Job summary

KBI Biopharma, Inc. is seeking an experienced manufacturing operations professional to lead technical support on a 24/7 GMP biopharmaceutical manufacturing floor in Durham, NC.

You will drive new product introductions, draft batch records, mentor staff, and lead process-improvement projects while partnering with QA and Compliance to close deviations. The role requires a strong background in downstream operations, cell culture or fermentation, and a bachelor's degree with 6+ years of related

Qualifications

• Bachelor's degree in a related scientific or engineering discipline preferred.
• 6+ years of related experience and/or training or equivalent.
• Experience in downstream operations and cGMP manufacturing preferred.
• Fluent in English with strong written and verbal communication skills.
• Ability to work with minimal supervision in a fast-paced environment.

Responsibilities

• Lead technical support activities for GMP manufacturing operations.
• Draft manufacturing batch records and procedures; support changes.
• Support new product/process introductions and facility fit.
• Coach and mentor manufacturing associates; support trainers.
• Drive process improvements and lead CAPA initiatives.
• Coordinate deviations investigations with QA/compliance.
• Support Operational Excellence initiatives (5S, lean).
• Ensure safety, quality, and regulatory requirements on the shop floor.

Skills

Downstream operations knowledge

Cell culture

Fermentation

GMP manufacturing

Leadership / mentoring

Process improvement

Quality & compliance awareness

English communication

Education

Bachelor's degree in science or engineering

Job description

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

Job Responsibilities include, but are not limited to, the following:

• 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 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.

Knowledge, Skills, Abilities

Demonstrated knowledge of downstream operations is preferred, 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 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.

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.

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.