Scientist for Global QC Raw Materials Tech Transfer
FUJIFILM Diosynth Biotechnologies
Dato: for 6 dage siden
By: Hillerød, Region Hovedstaden
Kontrakttype: Fuld tid
Who are we looking for?
We are looking for a scientist with experience with raw material method assessment and implementation for the global QC Raw Material Tech Transfer team. The global QC Raw Material Tech Transfer team is accountable for onboarding raw materials for new and existing programs. The position is based at our site in Hillerød, Denmark (FDBD).
About FUJIFILM Diosynth Biotechnologies
Follow Your Genki to FUJIFILM Diosynth Biotechnologies
The work we do at FUJIFILM Diosynth Biotechnologies (FDB) has never been more important—and we are looking for talented candidates to join us. We’re 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 create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. Here, you’ll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. We’re proud to cultivate a culture that will fuel your passion, energy, and drive—what FDB calls Genki. Join us and discover a community that thrives on diversity and never scares away from a complex challenge. At FDB, you determine what’s possible.
About The FDBD Site
Our Manufacturing site in Hillerød, Denmark, brings together a complete range of expertise, capabilities and technologies to manufacture advanced biologics.
About The Role
As a scientist in the Global Raw Material Tech Transfer team, you will collaborate with a cross-functional team to establish testing strategies for the raw materials our customers need for their manufacturing process. In addition to this you will oversee the verification/validation for any new methods performed by the contract laboratories we collaborate with.
About The Department
Global QC Raw Material Tech Transfer is a newly established global team, currently consisting of approximately 20 employees based both at FDBD in Hillerød, Denmark and FDBN in Holly Springs, US.
The department supports tech transfers to both sites and is responsible for aligning the raw material strategy across these sites. We are involved in identifying the right raw materials together with our clients, we are responsible for ensuring compendial requirements (Ph. Eur. USP, JP, JPE, ChP etc.) are fulfilled when setting the specifications for the materials and we have a close collaboration with the local QC Raw Material team when programs move into the operational phase. We have an informal work environment where we strive to have fun while keeping the high pace.
We are looking for a structured, pragmatic and diplomatic person that can support the drug product area within Global QC Raw Materials Tech Transfer. You will be accountable for ensuring operational readiness of the drug product facility in relation to raw material topics. Additionally, you will be responsible for collaborating internally with the raw material team and externally with our customers to define, evolve and determine the testing strategy for primary packaging, materials and utilities used in the drug product facility. Additionally, you will be involved in tech transfers for new customers and be a key stakeholder in ensuring method capabilities both internally and externally for the primary packaging components.
Job tasks
Your Primary Tasks Will Be:
We are looking for a candidate with the following background and skill set:
Professional Qualifications:
As a person you have a positive can-do attitude, you are proactive, pragmatic and can move easily between tasks. You are organized, work efficiently and can structure your tasks in a way to ensure projects are completed on time – even when the priorities change. You have good communication skills and can communicate well and clearly with both internal and external stakeholders. You take responsibility for your tasks and ensure escalation to the project team and management when needed. You are self-motivating and always willing to give a helping hand to other team members when needed – and you thrive in a busy environment.
Our quality department (QC) in Hillerød consists of more than 200 employees divided into several analytical and support functions. We strive to have a strong QC-team spirit (OneQC) where we can support and cooperate across functions and teams – not solely for reaching goals but also to strengthen personal development. The foundation in our QC-departments is our employees and our success is only possible due to our competent and dedicated colleagues that work to make a difference for QC, our production facility, customers, and patients all over the world.
As an invaluable part of a leading CDMO, QC strives to continuously improve our processes and analytical methods while creating a dynamic and inspiring environment where there are great possibilities to be part of changes and drive improvements.
Application
If this could be your future position, please upload your application and CV. We will review relevant candidates for job interviews and will close the position as soon as we have found the right candidate.
If you have further questions or need information, please contact Associate Director, Patricia Jacobsen by email [email protected]
About FUJIFILM Diosynth Biotechnologies
FUJIFILM Diosynth Biotechnologies, a subsidiary of FUJIFILM Corporation, is a world-leading contract development and manufacturing organization (CDMO) with experience in the development and manufacture of biologics, vaccines, and advanced therapies. The company operates a global network with major locations in the Unites States of America, the United Kingdom and Denmark and it is building a new manufacturing site in Holly Springs, North Carolina, USA.
FUJIFILM Diosynth Biotechnologies has over thirty years of experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems. The company offers a comprehensive list of services from cell line development using its proprietary pAVEway microbial and ApolloX cell line systems to process development, analytical development, clinical and FDA-approved commercial manufacturing.
We use our skills, dedication, and ambition to enable impact for the world’s most innovative biotech and biopharma companies reimagining healthcare’s potential. We work across the entire lifecycle of our customers’ products – enabling success throughout. Every cure, vaccine, biologic, and advancement we contribute to starts with our people and our passion. We fuel one another’s passion, help accelerate progress, expand capabilities, strengthen innovation, and improve processes to improve lives.
What We Offer
We offer the chance to be part of a global workplace where passion, drive and commitment are met with opportunities for professional and personal development. Deeply committed to diversity and inclusion, we ensure that everyone no matter their background or gender has an opportunity to develop. We take pride in enriching our communities, caring for our environment, and cultivating a world of opportunity for future generations.
We aim to foster a collaborative, innovative and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values. We pursue our fullest potential as individual contributors and team members. We strive to be the employer of choice and offer a competitive compensation and benefit package.
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.
We are looking for a scientist with experience with raw material method assessment and implementation for the global QC Raw Material Tech Transfer team. The global QC Raw Material Tech Transfer team is accountable for onboarding raw materials for new and existing programs. The position is based at our site in Hillerød, Denmark (FDBD).
About FUJIFILM Diosynth Biotechnologies
Follow Your Genki to FUJIFILM Diosynth Biotechnologies
The work we do at FUJIFILM Diosynth Biotechnologies (FDB) has never been more important—and we are looking for talented candidates to join us. We’re 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 create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. Here, you’ll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. We’re proud to cultivate a culture that will fuel your passion, energy, and drive—what FDB calls Genki. Join us and discover a community that thrives on diversity and never scares away from a complex challenge. At FDB, you determine what’s possible.
About The FDBD Site
Our Manufacturing site in Hillerød, Denmark, brings together a complete range of expertise, capabilities and technologies to manufacture advanced biologics.
About The Role
As a scientist in the Global Raw Material Tech Transfer team, you will collaborate with a cross-functional team to establish testing strategies for the raw materials our customers need for their manufacturing process. In addition to this you will oversee the verification/validation for any new methods performed by the contract laboratories we collaborate with.
About The Department
Global QC Raw Material Tech Transfer is a newly established global team, currently consisting of approximately 20 employees based both at FDBD in Hillerød, Denmark and FDBN in Holly Springs, US.
The department supports tech transfers to both sites and is responsible for aligning the raw material strategy across these sites. We are involved in identifying the right raw materials together with our clients, we are responsible for ensuring compendial requirements (Ph. Eur. USP, JP, JPE, ChP etc.) are fulfilled when setting the specifications for the materials and we have a close collaboration with the local QC Raw Material team when programs move into the operational phase. We have an informal work environment where we strive to have fun while keeping the high pace.
We are looking for a structured, pragmatic and diplomatic person that can support the drug product area within Global QC Raw Materials Tech Transfer. You will be accountable for ensuring operational readiness of the drug product facility in relation to raw material topics. Additionally, you will be responsible for collaborating internally with the raw material team and externally with our customers to define, evolve and determine the testing strategy for primary packaging, materials and utilities used in the drug product facility. Additionally, you will be involved in tech transfers for new customers and be a key stakeholder in ensuring method capabilities both internally and externally for the primary packaging components.
Job tasks
Your Primary Tasks Will Be:
- Author and review justification specification reports for raw materials
- Author and review transfer summary reports for raw materials
- Review external verification/validation protocols and reports
- Work with contract laboratory organizations during method transfers of validated methods and compendial method verifications
- Analytical method support to the local QC Raw Material testing team, including OOS investigational support as a SME
- Change control Assessment of e.g. new material onboarding changes, vendor changes, compendial updates and customer updates to raw material specifications
- Continuous improvement projects
We are looking for a candidate with the following background and skill set:
Professional Qualifications:
- Master of Science within Pharmaceutical Sciences, Chemical Engineering, Chemistry, Biochemistry, Protein Chemistry, Biology or equivalent
- Solid understanding of GMP guidelines with minimum 3 years of proven experience, ideally from the pharmaceutical industry, e.g. from a QC raw material laboratory or similar
- Broad experience with analytical methods, such LC-MS/MS, GC-MS, HPLC and FT-IR as well as the capability of being able to absorb and utilize new knowledge quickly
- Knowledge of classical methods e.g. titrations and wet chemistry methods
- Experience in Ph. Eur., USP, JP, JPE, ChP etc.
- Knowledge of ICH guidelines is an advantage, but not a requirement
- Experience with method transfer and validation/verification
- Excellent oral and written communication skills
- Excellent English oral and written communication skills
As a person you have a positive can-do attitude, you are proactive, pragmatic and can move easily between tasks. You are organized, work efficiently and can structure your tasks in a way to ensure projects are completed on time – even when the priorities change. You have good communication skills and can communicate well and clearly with both internal and external stakeholders. You take responsibility for your tasks and ensure escalation to the project team and management when needed. You are self-motivating and always willing to give a helping hand to other team members when needed – and you thrive in a busy environment.
Our quality department (QC) in Hillerød consists of more than 200 employees divided into several analytical and support functions. We strive to have a strong QC-team spirit (OneQC) where we can support and cooperate across functions and teams – not solely for reaching goals but also to strengthen personal development. The foundation in our QC-departments is our employees and our success is only possible due to our competent and dedicated colleagues that work to make a difference for QC, our production facility, customers, and patients all over the world.
As an invaluable part of a leading CDMO, QC strives to continuously improve our processes and analytical methods while creating a dynamic and inspiring environment where there are great possibilities to be part of changes and drive improvements.
Application
If this could be your future position, please upload your application and CV. We will review relevant candidates for job interviews and will close the position as soon as we have found the right candidate.
If you have further questions or need information, please contact Associate Director, Patricia Jacobsen by email [email protected]
About FUJIFILM Diosynth Biotechnologies
FUJIFILM Diosynth Biotechnologies, a subsidiary of FUJIFILM Corporation, is a world-leading contract development and manufacturing organization (CDMO) with experience in the development and manufacture of biologics, vaccines, and advanced therapies. The company operates a global network with major locations in the Unites States of America, the United Kingdom and Denmark and it is building a new manufacturing site in Holly Springs, North Carolina, USA.
FUJIFILM Diosynth Biotechnologies has over thirty years of experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems. The company offers a comprehensive list of services from cell line development using its proprietary pAVEway microbial and ApolloX cell line systems to process development, analytical development, clinical and FDA-approved commercial manufacturing.
We use our skills, dedication, and ambition to enable impact for the world’s most innovative biotech and biopharma companies reimagining healthcare’s potential. We work across the entire lifecycle of our customers’ products – enabling success throughout. Every cure, vaccine, biologic, and advancement we contribute to starts with our people and our passion. We fuel one another’s passion, help accelerate progress, expand capabilities, strengthen innovation, and improve processes to improve lives.
What We Offer
We offer the chance to be part of a global workplace where passion, drive and commitment are met with opportunities for professional and personal development. Deeply committed to diversity and inclusion, we ensure that everyone no matter their background or gender has an opportunity to develop. We take pride in enriching our communities, caring for our environment, and cultivating a world of opportunity for future generations.
We aim to foster a collaborative, innovative and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values. We pursue our fullest potential as individual contributors and team members. We strive to be the employer of choice and offer a competitive compensation and benefit package.
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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