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The Manager oversees cGMP manufacturing activities, including process implementation, daily personnel management, and production scheduling. They ensure high-quality output, maintain compliance with regulatory standards, and provide direct floor oversight to support and develop the manufacturing team.
Requirements
Candidates must have a Bachelor's degree in a scientific or engineering discipline with 4+ years of industry experience, or a high school degree with 10 years of experience. Additionally, 4+ years of leadership experience and the ability to work 12-hour overnight shifts in a clean room environment are required.
Full job 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 (Nights) - 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 in a 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 a Night Shift, starting at 6:00 PM and ending at 6:30 AM.
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, targeting KPI 80%.
Requirements:
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 in 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 includes working overnight.
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: $118,000 - $148,000
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.
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 is an award-winning biopharmaceutical contract services organization providing fully-integrated, accelerated drug development and biomanufacturing services to pharmaceutical and biotechnology companies globally.
With each of our 500+ client partners, we have worked closely to personalize and rapidly accelerate their drug development programs. Built upon a foundation of world-class analytical capabilities, we deliver efficient process development and clinical and commercial cGMP manufacturing services for mammalian and microbial programs.
KBI is proud to be a JSR Life Sciences Company.
Offices: 4117 Emperor Blvd, Durham, North Carolina 27703, US · 1101 Hamlin Rd., Durham, NC 27704, US · 2500 Central Ave., Boulder, CO 80301, US · 1450 Infinite Drive., Louisville, CO 80027, US · 47 National Way, Durham, North Carolina 27703, US
How much do Management & Leadership jobs in Boulder, CO pay?
Based on 335 listings with disclosed salaries, most management & leadership jobs in Boulder, CO pay between $44k–$187k per year. Individual offers vary with seniority, company size, and specialization.
How many Management & Leadership jobs are open in Boulder, CO right now?
There are currently 398 open management & leadership positions in Boulder, CO listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Management & Leadership roles in Boulder, CO?
Companies currently hiring include Google, Scout Clean Energy, Symmetry Financial Group, Northrop Grumman, Northrop Grumman Mission Systems, Inc., among others. Browse the listings above to see every active employer.
Are there remote or hybrid Management & Leadership jobs in Boulder, CO?
Yes — 110 of the 398 open management & leadership positions offer remote or hybrid work (40 remote, 70 hybrid).
How do I apply for Management & Leadership jobs in Boulder, CO?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.