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Position Overview

The Manufacturing Lead (Downstream) oversees and performs Current Good Manufacturing Practice (CGMP) manufacturing operations for manufactured biopharmaceutical products. This role ensures the effective use of material, equipment, and personnel while making products at high-quality levels. Additionally, this role is recognized as a subject matter lead regarding manufacturing processes and leads more junior members of the shift through manufacturing processes.

Job Description

Responsibilities:

• As a highly skilled specialist, contributes to the development of concepts and techniques.
• Completes complex tasks in creative and effective ways.
• Acts independently to determine methods and procedures on new assignments. Often acts as a facilitator and team leader.
• Consistently works on complex assignments requiring independent action and a high degree of initiative to resolve issues. Makes recommendations for new procedures.
• Assists the Production manager with developing team members through continuous coaching and training.
• Ensures team activities, equipment, facilities, and personnel are operated and maintained in a state of compliance with appropriate requirements.
• Ensures effective manufacturing delivery upon production supply schedule.
• Mentors technicians with the goal of achieving employee empowerment.
• Assists the team with the development of objectives and ensures alignment with site and department goals.
• Provides ongoing feedback to managers on technician performance, development, and training needs.
• Provides real-time coaching and feedback to team members and assists with training, as needed.
• Serves as the senior technical lead over floor activities and manufacturing processes.
• Helps troubleshoot equipment problems, and identifies the need for new equipment or modifications to existing equipment to optimize throughput.
• Provides feedback to support teams for troubleshooting and continuous improvement purposes.
• Observes all critical operations to ensure deviation-free / right-first-time performance and building skills with technicians.
• Meets daily shift goals and provides team assignments to meet those goals.
• Ensures room and equipment are in a ready state (e.g., cleaning, logbook, and equipment staged for a project) prior to the start of a shift or daily activities.
• Leads the tier 1 meetings to ensure detailed turnover of information to the oncoming shift.
• Attends departmental and team meetings focused on equipment or process improvement to provide SME feedback.
• Serves as liaison between shifts, teams, and other departments to give updates, as required.
• Provides escalation to management when process issues arise, or daily goals will be delayed, as needed.
• Ensures GMP documents are completed accurately and timely (provides a daily review of batch records and logbooks).
• Ensures completion of real-time documentation of observations or execution events and initiates any necessary investigations or deviations.
• Initiates safety incidents and supports corrective and preventative actions.
• Ensures technicians are qualified to perform tasks prior to execution.
• Ensures the execution and closure of SFOs in Pas-X prior to records being removed from the floor.
• Performs other duties, as assigned.

Requirements:

• High School Diploma/GED with 8 years of experience in a related technical field
• Experience with chromatography, columns and column packing, UFDF systems, filtration and aseptic techniques.
• Demonstrated leadership, interpersonal, technical aptitude, and problem-solving skills
• Strong teambuilding skills, including the ability to coach/develop teams, provide training, motivate and empower others, and conflict resolution
• Goal-oriented and able to manage risks
• Ability to be flexible and manage multiple priorities
• Strong computer skills with proficiency in using Microsoft Office (Word, Excel, PowerPoint, etc.) for data gathering, entry, and reporting
• Good communication, both written and verbal
• Must be able to work shift, including weekends or nights, per assigned shift schedule

Preferred Requirements:

• Bachelor’s degree in Life Science, Engineering or another technical field
• Experience leading and coaching others

Physical Demands:

• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• Ability to stand for prolonged periods of time up to 240 minutes
• Ability to sit for prolonged periods of time up to 240 minutes.
• Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers.
• Ability to conduct work that includes moving objects up to 33 pounds.
• Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions

Environmental Conditions:

• Will work in warm/cold environments (0-100F).

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

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