Job Summary:

This position is on a 2-2-3 shift.

Night shift schedule is 7pm - 7am

A Supervisor in the Manufacturing Support Department will coordinate and supervise, Manufacturing Support operations such as Cleaning of the GMP Facilities, PAR operations, Raw Material Sampling operations and Process Waste Operations. The Supervisor will ensure compliance in all operations that align with all regulatory guidelines, company policies, Standard Operating Procedures (SOP) and Policy Documents (PD).

Manufacturing Support Supervisor will supervise and support all Manufacturing Support operations accurately and apply their GMP knowledge and experience to troubleshoot operational issues. This includes facilitating additional support with external departments, such as responses required to maintain and ensure all Manufacturing Departments are operational which may require work schedule adjustments. The supervisor will guide, mentor and coach Manufacturing Support personnel ensuring each associate understands their daily task, performs their task with extreme efficiency, and coaches them to exceed all expectations and gives each associate the tools to become successful. The Supervisor of the Support Department will maintain a sense of ownership of all Support Department operations for his/her shift and ensure the resources are available, resources are coordinated, resources are efficient, and Quality is implemented in all aspects of the Support Department. Will be required to use the Quality System (CAPA, Deviation, Change Control, and Training) to ensure compliance within the Department. The expectation of the Supervisor of the Manufacturing Support Department is to lead by example and to model the KBI Values. It is the duty as a Supervisor to ensure the safety and compliance of each personnel while on KBI property.

Job Duties:

• Support and trains all supervised associates to complete daily task.

• Ensures learning and development of departmental associates.

• Responsible for and ensures manufacturing compliance with GDP’s and cGMP’s with logbook and record entries.

• Facilitate responsibilities required to support operations.

• Communicates with external departments to ensure required task are scheduled and completed.

• Initiate Compliance Quality Systems such as Deviations, CAPAs and Change Controls that are related to the Support Department JOB DESCRIPTION T-0094 Rev 0 Job Description Template

• Performs/supports annual/biannual performance reviews of direct/indirect reports within the Support department.

• Adheres all safety requirements and report unsafe conditions.

• Ability to work outside routine schedules to maintain support operations when necessary.

• Write/Revise Department SOP’s, TRN’s, Manufacturing Records

• Perform Change Control Assessment related to Support Department functions.

• Requires strategic planning and decision making to ensure continual operations while remaining compliant with various policies and procedures.

• Reviews and approves direct reports timesheets and PTO request.

Requirements:

• High School Diploma with 8+ years of relevant manufacturing experience; or Associate Degree with 6 years of relevant manufacturing experience; or Bachelor’s Degree with 4 years of relevant manufacturing experience.

• 2+ years of prior leadership/supervisory experience.

• Knowledge of Quality Assurance systems and regulatory agency guidelines is preferred.

• Excellent written and verbal communication skills are required.

Working Conditions:

• Hours may vary depending on business needs and unforeseen circumstances.

• Due to the use of Spor-Klenz, respirators (full faced and half faced respirators) are required for the job. Additionally, facial hair needs to be maintained short enough to ensure a good seal to properly wear the respirator.

• This position is considered “Essential Personnel” which requires 7 days a week work coverage even though the company closes, this position is required to ensure the cleaning is completed every day.

Salary Range: $101,000 - $138,600/yr.

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and employee recognition programs.

About KBI:

KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit www.kbibiopharma.com.

KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds – regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status – and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team.

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.

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.