What are the responsibilities and job description for the Manufacturing Manager (Days) position at KBI Biopharma?
Description
At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact.
Position Summary:
The Manager, Manufacturing - Manages the respective activities related to cGMP manufacturing, including the development and implementation of manufacturing methods, processes and operations for manufactured biopharmaceutical products. Ensures the effective use of material, equipment and personnel while producing products at high quality levels. Manages daily personnel requirements. We are looking for a strong leader that will have an instant impact, building a great team.
The Manager will review manufacturing procedures and train manufacturing personnel to ensure that manufacturing operations are conducted accurately, safely, and compliantly. The Manager will maintain a sense of ownership of the production processes manufacturing environment and facility. Following task execution, the Manager will review executed production batch records and production orders to ensure a comprehensive and accurate set of actions have occurred. It is management’s expectation that all deviations/events are documented and escalated according to KBI internal notification processes.
This is for 2 days on, 2 days off, 3 days on rotating shift schedule. The hours for this position are on a Day shift starting at 6:00 AM and ending at 6:30 PM.
Responsibilities:
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 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.
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.
At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact.
Position Summary:
The Manager, Manufacturing - Manages the respective activities related to cGMP manufacturing, including the development and implementation of manufacturing methods, processes and operations for manufactured biopharmaceutical products. Ensures the effective use of material, equipment and personnel while producing products at high quality levels. Manages daily personnel requirements. We are looking for a strong leader that will have an instant impact, building a great team.
The Manager will review manufacturing procedures and train manufacturing personnel to ensure that manufacturing operations are conducted accurately, safely, and compliantly. The Manager will maintain a sense of ownership of the production processes manufacturing environment and facility. Following task execution, the Manager will review executed production batch records and production orders to ensure a comprehensive and accurate set of actions have occurred. It is management’s expectation that all deviations/events are documented and escalated according to KBI internal notification processes.
This is for 2 days on, 2 days off, 3 days on rotating shift schedule. The hours for this position are on a Day shift starting at 6:00 AM and ending at 6:30 PM.
Responsibilities:
- Execute manufacturing requirements by meeting or exceeding productivity, quality and capacity objectives as set forth by management. Through direct floor oversight, manage daily schedules of production activities, outline staff assignments, material and equipment requirements, and training needs. Assist staff with on the floor execution of production tasks.
- In cooperation with customer representatives, process development and management personnel, look for opportunities to improve operations. Closely coordinate potential process improvements with quality and regulatory to assure cGMP compliance.
- Hire, develop and motivate manufacturing operators. Assure continual technical development of staff. Conduct annual performance reviews for staff. Conduct more frequent reviews for new hires and personnel who have shown performance deficiencies.
- Assist with management of production/operation planning and scheduling.
- Manager on-the-floor-Oversight is key operating expectation for this position, target KPI 80%.
- Bachelor’s degree in a related scientific or engineering discipline and 4 years industry experience (fermentation, cell culture, purification); or high school degree and 10 years' experience, or equivalent.
- 4 years prior leadership/supervisory experience.
- Excellent written and verbal communication skills are required.
- Energetic, motivated and dynamic individual.
- Must be organized and able to focus on a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.
- Must possess strong leadership, ability to hold team accountable, manage difficult conversations, and discipline when necessary.
- The job requires working 12-hour shifts which may include working overtime.
- 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 regularly utilizes equipment and materials which include mechanical hazards, chemical hazards, electricity hazards, and tripping and falling hazards. The noise level in the environment is moderate to high.
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 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.
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.
Salary : $118,000 - $148,000