SR Manufacturing Project Lead
SR Manufacturing Project Lead
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Position Overview
The Senior Manufacturing Project Lead will lead and organize manufacturing projects and support activities. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation.
Company Overview
Follow Your Genki to North Americas largest stateoftheart Life Science Manufacturing Facility & CDMO
The work we do at FUJIFILM Diosynth Biotechnologies has never been more importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate missiondriven people like you who want to make a real difference in peoples lives. Join FUJIFILM Diosynth Biotechnologies 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 newlargescale 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 endtoend cell culture CDMO provider in North America.
The new site will offer endtoend solutionsto our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture it will alsoprovideautomated fillfinish and assembly packaging and labeling services. The new stateoftheart facility is located in Holly Springs North Carolina United States.
Job Description
What Youll Do
During the Project Phase:
- Leads operational readiness initiatives as well as site commissioning and qualification efforts
- Manages cost and schedule of project delivery items and manufacturing operational projects
- Supports organization and development of operational readiness
In Operations:
- Leads manufacturing focused projects at the request of leadership
- Actively participates and collaborates to meet the need and expectations set forth by Factory X initiatives and other cross site projects as assigned
- Supports materials management within manufacturing
- Drives column packing and changeover activities including the generation of documents
- Leads manufacturing support items which could include but not limited to:
- Manufacturing change controls and corrective and preventive actions (CAPAs)
- Short flow investigations and alert/action limits
- Finite manufacturing schedules
- Continuous improvement escalation and mitigation of manufacturing issues
- Cross site or local manufacturing projects
- Technology transfer manufacturing deliverables
- Assist in regulatory inspections and audits
- Perform other duties as assigned.
Basic Requirements
- High School Diploma or GED
- 12 years of related experience
Preferred Requirements
- Associates Degree in Life Sciences or Engineering 10 years of direct experience OR
- Bachelors degree in life sciences or engineering 8 years of direct experience OR
- Equivalent Military experience/training
- Previous experience in a cGMP manufacturing environment
- Relevant experience in CAPEX/OPEX projects
- Ability to lead teams facilitate workshops and effectively communicate project status
- Experience in campaign lifecycle activities
- Understanding of manufacturing equipment operations and cadence
- BioWorks or BTEC Capstone cGMP coursework preferred
PHYSICAL REQUIREMENTS
PHYSICAL DEMANDS
- Ability to discern audible cues
WORKING ENVIRONMENT
PHYSICAL DEMANDS
- Ability to stand for prolonged periods of time.
- Ability to sit for prolonged periods of time.
- Ability to conduct activities using repetitive motions that include wrist hands and/or fingers.
- Ability to conduct work that includes moving objects up to 10 lbs.
ENVIRONMENTAL CONDITIONS
- Will work in heights greater than 4 feet
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 viaemail 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.
EEO Information
Fujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.
ADA Information
If you require reasonable accommodation in completing this application interviewing completing any preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department .
Required Experience:
Senior IC
Employment Type
Unclear
