What are the responsibilities and job description for the Scientist II, Analytical Development Tech Transfer position at FUJIFILM Diosynth Biotechnologies?
The Analytical Development (AD) Tech Transfer (TT) Scientist 2 manages and coordinates the transfer of drug substance and drug product QC analytical methods from customers into the large-scale manufacturing facility, from first campaign through commercialization (clinical through process performance qualification/commercial). This role interfaces with customers and cross-functional teams to scope analytical testing plans and achieve project milestones. This role authors/reviews transfer plans, method transfer documents, transfer summary reports and specification justification reports, as needed. This role effectively communicates and operates between different teams, ensuring compliance with regulations, and optimizing processes for efficient transfer of knowledge and technology.
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
Will work in environment which may necessitate respiratory protection
Ability to discern audible cues.
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
Abiltiy to stand for prolonged periods of time up to 120 minutes
Abiltiy to sitfor prolonged periods of time up to 120 minutes
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.
Ability to conduct work that includes moving objects up to 10 pounds.
Will work in warm/cold environments
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
- Works with customers and the TT program to lead and manage the QC AD TT process
- Supports analytical method TT and execution including method verification, transfer and validation
- Interfaces with customers and program management to identify analytical needs and performs risk and gap assessments during project scoping
- Develops project plans that align with program scope and customer expectations
- Ensures the analytical team understands business goals and customer expectations and delivers results according to project deadlines
- Participates in regular meetings for TT programs with cross-functional teams and key stakeholders
- Serves as the subject matter expert (SME) to review, author and deliver SOPs, transfer plans, protocols, reports, and transfer summary reports
- Liaises with Contract Laboratory Organizations (CLOs), QC testing teams, Quality Assurance (QA), and Process Science groups to ensure prioritization of non-compendial and compendial method transfer activities according to deadlines
- Collaborates with the LIMS team and IT department to build new analytical method functionality that meets end-user and customer requirements
- Ensures compendial method oversight and scientific guidelines (e.g. ICH, EMA, FDA, etc.)
- Supports regulatory requests and inspections
- Supports the QC AD team to investigate any project challenges with necessary risk assessment tools and techniques
- Support best practices for TT and PPQ strategies globally, as required
- Performs other duties, as assigned
- B.S. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 9 years of analytical laboratory experience preferably in biotechnology, Pharma, Contract Research Organization (CRO), or Contract Laboratory Organization (CLO)
- 4-6 years experience in a GMP environment
- M.S. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 7 years of experience, OR
- Ph.D. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 5 years of experience
- Experience with Customer Relationship Management
- Prior drug substance or manufacturing experience, including process validation, transfer, commercialization, and manufacturing support and troubleshooting
- Experience using quality systems (e.g., deviation management system, change control, corrective and preventive action (CAPA), document management system)
Will work in environment which may necessitate respiratory protection
Ability to discern audible cues.
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
Abiltiy to stand for prolonged periods of time up to 120 minutes
Abiltiy to sitfor prolonged periods of time up to 120 minutes
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.
Ability to conduct work that includes moving objects up to 10 pounds.
Will work in warm/cold environments
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).
