Supervisor, Manufacturing Documentation

Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FDB has never been more important and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives.

Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe.

We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business.

This will be the largest end-to-end cell culture CDMO provider in North America. The new site will offer end-to-end solutionsto our customers looking to manufacture biopharmaceuticals in the US.

In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services.

The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

External US

About This Role

The Supervisor of Manufacturing Documentation leadsthe manufacturing documentation and recipe driven operations team and their associated activities to ensure compliant and reliable production.

What You’ll Do

During the project phase

• Provides oversight and leads operational readiness projects including but not limited to leading the creation or transfer from existing large-scale facility, manufacturing support team business processes to ensure good manufacturing practice (GMP) operational readiness
• Leads and builds the manufacturing documentation team
• Administers company policies such as time off, shift work, and inclement weather that directly impact employees
• Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.)
• Other duties, as assigned

In operations

• Manages and develops direct reports from support manufacturing team
• Oversees and coordinates the workload of manufacturing documentation and recipe driven operations team
• Leads the creation and lifecycle management of manufacturing standard operating procedures (SOPs), work instructions (WIs) and process recipes
• Supports and acts as a secondary functional manufacturing documentation lead for regulatory inspections and audits
• Administers company policies such as time off, shift work, and inclement weather that directly impact employees
• Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.)
• Coaches and guides direct reports to foster professional development
• Participates in the recruitment process and retention strategies to attract and retain talent, as needed
• Addresses performance gaps, employee questions and concerns, and partners with HR as needed for resolution
• Other duties, as assigned

Who You Are

You have the ability to collaborate with manufacturing and other functional areas. You have strong organizational skills and project management capabilities.

You actively champion continuous improvement practices and ideas. You have an advanced understanding of good manufacturing practices, inspection requirements, safety, and manufacturing operations.

You have the ability to coach, lead, and develop individual contributors. You have the ability to effectively present information to others.

You have the ability to travel domestic and international up to 25% during project phase and operations. You must be flexible to support 24 / 7 manufacturing facility.

Basic Requirements

• High School diploma / GED with 6 years related experience OR
• Bachelor’s Degree in Life Science, Engineering, or related field with 2 years related experience OR
• Master’s degree in Life Science, Engineering, or related field with no prior experience
• Experience directly supporting manufacturing
• Experience with regulatory inspections, investigations and change management

Preferred Requirements

• Previous experience in pharmaceutical or biological manufacturing operations
• Previous experience leading others in a pharmaceutical or biological manufacturing facility
• Experience working in a changing environment within a project driven organization
• Lean certification or similar certifications

PHYSICAL REQUIREMENTS

PHYSICAL DEMANDS

Ability to discern audible cues

WORKING EN VIRONMENT

PHYSICAL DEMANDS

• Ability to stand for prolonged periods of time - 30 Minutes
• Ability to sit for prolonged periods of times
• Ability to operate machinery and / or power tools
• Ability to conduct work that includes moving objects up to 10 pounds

ENVIRONMENTAL CONDITIONS

• Will work in warm / cold environments
• Will work in outdoor elements such as precipitation and wind

FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.

If an accommodation to the application process is needed, please email .

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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