What are the responsibilities and job description for the Sr. Specialist 1, QC Program Management Technical Transfer and Sample Support position at FUJIFILM Diosynth Biotechnologies?
The Sr. Specialist 1, QC Technical Transfer and Sample Support (SS) provides technical support through effective project management of the QC Sample Plans and QC Specifications in close collaboration with relevant stakeholders, including customers. The Sr Specialist 1, TT/SS interfaces with customers to scope QC Sample Plans and QC Specifications. This role participates in collaborations with cross-functional teams as a representative of QC. This role supports the timely completion of project milestones and deliverables. This role supports Good Manufacturing Practices (GMP) compliant laboratory operations in accordance with regulatory guidelines and participates in audits and inspections.
Company Overview
Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO
The work we do at FUJIFILM Diosynth Biotechnologies 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 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 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 solutions to 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.
Job Description
What You'll Do
Ability to discern audible cues
Ability to inspect or perform a task with 20/20 correct vision, visual acuity, including distinguishing color.
Ability to ascend or descend ladders, scaffolding, ramps, etc.
Ability to stand for prolonged periods of time up to 60 minutes.
Ability to sit for prolonged periods of time up to 60 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 10 pounds.
Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions.
Will work in small and/or enclosed spaces.
Will work in heights greater than 4 feet.
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.
EEO Information
Fujifilm is committed to 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 pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).
Company Overview
Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO
The work we do at FUJIFILM Diosynth Biotechnologies 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 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 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 solutions to 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.
Job Description
What You'll Do
- Collaborates with customers and stakeholders from QC and DS Manufacturing (DSM) to support tech transfers of new customer projects as they
- Participates in updates of controlled GMP documents related to QC Sample Plans and QC Specifications
- Participates in writing and review of change controls of QC Sample Plans for both internal and external changes together with relevant
- Manages continuous improvement of QC Sample Plans and QC Specifications as needed
- Applies holistic quality system approach through identifying and solving technical and compliance gaps.
- Identifies areas for improvement or remediation related to quality or process and leads through completion and sustainable implementation
- Participates in team compliance activities including writing, changing, and maintaining GMP documents in collaboration with relevant stakeholders and QA
- Ensures compliance with platform, procedures, and global QC vision. Supports management in training compliance with policies and inspections.
- Supports regulatory requests, audits, and inspections
- Collaborates with the LIMS team and IT department to build DS/DP sample plan and specification functions that meet end-user and customer
- Performs other duties as assigned
- Bachelors in Biological Sciences, Engineering, or related science field with 3 years of relevant experience OR
- Masters in Biological Sciences, Engineering, or related science field with 1 years of relevant experience
- Prior experience with project management in biotechnology, Pharma, Contract Research Organization (CRO), or Contract
- 1-3 years’ experience in a GMP environment.
- Prior experience in leading technical writing initiatives.
- Experience with Customer Relationship Management
- Prior drug substance or manufacturing experience, including process validation, transfer, commercialization, and manufacturing support
- Experience using quality systems (e.g., deviation management system, change control, corrective and preventive action (CAPA),
- Prior experience in participating in project improvement management.
Ability to discern audible cues
Ability to inspect or perform a task with 20/20 correct vision, visual acuity, including distinguishing color.
Ability to ascend or descend ladders, scaffolding, ramps, etc.
Ability to stand for prolonged periods of time up to 60 minutes.
Ability to sit for prolonged periods of time up to 60 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 10 pounds.
Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions.
Will work in small and/or enclosed spaces.
Will work in heights greater than 4 feet.
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.
EEO Information
Fujifilm is committed to 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 pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).
