Manager Manufacturing (Nights)

KBI Biopharma, Inc.; Boulder (CO); On-site; USD 118,000 - 148,000; Full time

Benefits offered by this job

Annual bonus

Medical coverage

Dental coverage

Vision coverage

Paid PTO and holidays

401K matching with vesting

Employee recognition programs

Job summary

KBI Biopharma, Inc. is seeking a Manager, Manufacturing (Nights) in Colorado to lead cGMP manufacturing operations, shaping methods, processes and batch records while ensuring safety, quality and compliance on a 2-on/2-off/3-on night schedule from 6:00 PM to 6:30 AM.

You will manage staffing, training and continuous improvement with a focus on KPI achievement, coordinating with quality, regulatory and production teams to sustain aggressive production goals and clean room standards.

Qualifications

• 4+ years leadership/supervisory experience.
• Excellent written and verbal communication skills.
• Organized, multi-tasking in a fast-paced environment.
• Experience in a cGMP biotechnology facility and clean rooms.
• Ability to manage and mentor manufacturing staff.

Responsibilities

• Execute manufacturing requirements to meet productivity, quality and capacity KPIs.
• Oversee daily floor schedules, staff assignments, materials and equipment needs.
• Assist staff with on-the-floor execution of tasks.
• Collaborate with customer, process development and quality to improve operations.
• Coordinate process improvements with quality and regulatory for cGMP compliance.
• Hire, develop and motivate manufacturing operators.
• Conduct periodic performance reviews and staff development.
• Support production planning and scheduling; on-the-floor oversight is key.
• Lead with a target KPI achievement of 80%.

Skills

Leadership

Communication

GMP Knowledge

Shift Management

Process Improvement

Training & Development

Education

Bachelor’s degree in a related scientific or engineering discipline

High school diploma with 10 years experience

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

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.

Benefits and Perks

• Annual bonus structure for all employees.
• Medical coverage.
• Dental coverage.
• Vision coverage.
• Paid PTO and holidays.
• 401K matching with 100% vesting in 60 days.
• Employee recognition programs.

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.