Senior Director, Process Engineering & Maintenance jobs in United States
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FUJIFILM Cellular Dynamics, Inc · 3 months ago

Senior Director, Process Engineering & Maintenance

FUJIFILM Cellular Dynamics, Inc is building the future of bioproduction in Holly Springs, North Carolina, with the opening of North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility. The Senior Director, Process Engineering & Maintenance is responsible for leading the process engineering and maintenance organizations, ensuring successful project start-up and ramp-up, while driving continuous improvement and optimizing manufacturing processes.

BiotechnologyHealth CareManufacturingPharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Develops strategies to ensure successful ramp-up of facility, meeting client expectations and operational excellence
Builds and leads a high-performing Process Engineering & Maintenance team fostering a culture of collaboration, growth, and dedication to achieving successful facility start-up and ramp-up to client expectations
Ensures the optimization, design and implementation of manufacturing processes and equipment
Manages technology transfer from customers to large scale manufacturing
Builds robust operations and drive continuous improvement initiatives to optimize performance
Ensures project implementation is well received throughout the organization by effectively communicating updates and changes
Develops functional strategies and objectives that align with organizational goals
Ensures all specifications and requirements are review and approved by the SME, responsible engineer (RE), or Manufacturing
Enforces adhere to project plans, strategies, and timeline ensuring successful execution
Optimizes tasks and overall workload for the FUJIFILM team and consultants, as needed
Encourages a culture that prioritizes continuous learning and development, including coaching and mentoring to ensure the team is positioned for long-term success
Evaluates the teams’ performance and implements measures to improve productivity and engagement to develop high-potential employees
Participates in the recruitment process and retention strategies to attract and retain talent, as needed
Performs other duties, as assigned

Qualification

Process EngineeringPeople ManagementBiotech ManufacturingCGMP ComplianceFDA RegulationsTeam DevelopmentContinuous ImprovementLeadershipCommunication Skills

Required

Bachelor's degree in life science or engineering related field with 12+ years of experience in a similar role in a large biotech / pharma environment; or
Master's degree in life sciences or engineering with 8+ years of experience in a similar role in a large biotech / pharma environment
10+ years of people management, leadership & team management experience
6+ years of experience in biotech / pharma manufacturing operations
Experience working in a changing, project-driven organization
Experience in a CGMP facility or working with FDA regulations

Preferred

Prior experience in a similar role in large projects from conceptual design phase to operations
4+ years of experience leading and developing leaders
Experience leading manufacturing or technical departments

Benefits

Medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions
An industry leading 401(k) savings plan
Insurance coverage
Employee assistance programs
Various wellness incentives
Paid vacation time
Sick time
Company holidays

Company

FUJIFILM Cellular Dynamics, Inc

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Fujifilm Cellular Dynamics, Inc. develops and manufactures biologically relevant human cells derived from induced pluripotent stem (iPS) cells.

H1B Sponsorship

FUJIFILM Cellular Dynamics, Inc has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (4)
2021 (1)
2020 (3)

Funding

Current Stage
Growth Stage

Leadership Team

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Blake Anson
Senior Director - Discovery Research Partnering
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Ilyas Singec
Chief Scientific Officer
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Company data provided by crunchbase