GMP Supporter in Drug Substance Documentation
3 days ago
GMP Supporter in Drug Substance Documentation
GMP Supporter in Drug Substance DocumentationApply locations: Hillerod
Time type: Full time
Posted on: Posted 2 Days Ago
Job requisition id: JR3978
Do you have the flair for compliance and can handle many stakeholders? Are you looking for a position where you can take on responsibility? Then a job as GMP Supporter in FUJIFILM Diosynth Biotechnologies (FDB) might be something for you. We are a worldwide Contract Development and Manufacturing Organization (CDMO) with sites in the US, UK and Denmark. In Hillerød we are currently around 1700 employees working with every aspect of biotech and pharmaceutical production.
About the department
In the department Drug Substance Manufacturing (DSM) Support we are responsible for supporting manufacturing operations with project management and compliance of procedures and documentation. Manufacturing Support consists of approx. 100 employees.
In the DSM Documentation team, we provide procedural support to GMP manufacturing and ensure compliance and document release activities in a timely manner. We create and maintain the document package for Drug Substance Manufacturing (DSM) and perform procedural changes as well as assess the impact of events.
About the position
Currently, 1 new position is open to do the following tasks:
- Coordinate different types of documents (e.g., BPRs, SLRs, logbooks, handbooks) for DSM.
- Issue Documents and labels for DSM.
- Review BPRs and logbooks.
- Create and maintain records and procedures by collecting information from stakeholders to supply manufacturing with compliant documents.
- Perform timely closure of action items to ensure reliable execution of production.
- Continuous improvement of the department processes and support of stakeholder improvement projects.
Qualifications
We are looking for a new colleague who is responsible, conscientious, and ready for professional development. You are able to navigate on your own, in a team, and among many stakeholders.
- Experience with cGMP and pharmaceutical manufacturing, preferably 2-5 years in the industry.
- Educational background is preferably a Bachelor within engineering, science, pharmacy, or similar.
- Knowledge about Cell Culture and Purification unit operations.
- We are an international company, and fluency in English is required.
About FUJIFILM Diosynth Biotechnologies
At FDBD we care about developing our employees When you start working with us, you are not just starting a new job. It is important that you can work individually as well as in a team and take responsibility for your own and your team's continuous development. As an employee in DSM Support, you will be thoroughly trained, and we will set new realistic goals so that you continue your development and support Fujifilm’s production in the best possible way.
Your application
If your qualifications meet our requirements, and we have sparked your interest in joining us, please apply as soon as possible. We will process the applications as they arrive.
For questions or doubts please reach out to Manager in Manufacturing Support Nina Hartling at +45 4194 9718.
FUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark, Teesside, UK, RTP, North Carolina, and College Station, Texas, USA. 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.
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.
FUJIFILM Diosynth Biotechnologies Denmark (FDBD) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identity, or any other protected class.
#J-18808-Ljbffr-
Head of Quality Assurance Drug Substance
2 weeks ago
Hillerød, Hillerød Kommune, Denmark FUJIFILM Diosynth Biotechnologies Full timeFUJIFILM Diosynth Biotechnologies is an industry-leading biologics contract development and manufacturing organization (CDMO) with a global presence in Hillerød, Denmark, Teesside, UK, RTP, North Carolina, and College Station, Texas, USA.We strive to be the employer of choice, offering a competitive compensation and benefit package that fosters a...
-
QP and Head of QA Drug Substance
4 months ago
Hillerød, Denmark FUJIFILM Diosynth Biotechnologies Full timeAre you motivated to lead and inspire four dedicated QA Drug Substance teams within a rapidly growing CDMO? Fujifilm Diosynth Biotechnologies in Hillerød is looking for a proactive and passionate individual to take on the role of Head of QA Drug Substance. This position offers a unique opportunity to embody our core values of trust, customer satisfaction,...
-
Hillerød, Denmark Fujifilm Diosynth Biotechnologies Full timeManufacturing Support Documentation Associate Apply locations Hillerod posted on Posted 22 Days Ago job requisition id JR3936 Do you have the flair for compliance and can handle many stakeholders? Are you looking for a position where you can take on responsibility? Then a job in FUJIFILM Diosynth Biotechnologies (FDB) might be something for you. We are a...
-
QA Drug Substance Operations Associate Manager
4 months ago
Hillerød, Denmark FUJIFILM Diosynth Biotechnologies Full timeQA Drug Substance Operations Associate Manager This is a unique position as the Team Lead for our Biological Drug Substance QA team. We are looking for a Team Lead for both our Upstream and Downstream QA teams. The Biological Drug Substance QA teams supports QA operations for our Drug Substance facility from Tech Transfer to releasing the product with focus...
-
Hillerød, Denmark FUJIFILM Diosynth Biotechnologies Full timeFUJIFILM Diosynth Biotechnologies are growing significantly as we are expanding capacity and capability over the coming years. To support the Manufacturing site in Hillerød, Denmark, on this exciting journey, we are looking for a talented and genkified person to become a part of the Drug Substance Manufacturing organization, as a Continuous Improvement...
-
Hillerød, Denmark Fujifilm Diosynth Biotechnologies Full timeContinuous Improvement Partner for QA Drug Substance Operations Continuous Improvement Partner for QA Drug Substance Operations Apply locations Hillerod time type Full time posted on Posted 25 Days Ago job requisition id JR3732 Are you a skilled and experienced CI partner eager to join a fast-growing CDMO? Apply for this position where you will be an...
-
Hillerød, Hillerød Kommune, Denmark Fujifilm Diosynth Biotechnologies Full timeWe are seeking a detail-oriented Regulatory Compliance Specialist to join our team in Hillerød, Denmark.FUJIFILM Diosynth Biotechnologies (FDB) is a leading Contract Development and Manufacturing Organization (CDMO) with sites worldwide. In our Hillerød location, we have approximately 1700 employees working on every aspect of biotech and pharmaceutical...
-
Senior Manager, Drug Substance Manufacturing
2 days ago
Hillerød, Denmark Novo Nordisk AS Full timeSelect how often (in days) to receive an alert: Create Alert Senior Manager, Drug Substance Manufacturing Category: Manufacturing Location: Hillerød, Capital Region of Denmark, DK Are you interested in an exciting opportunity to lead a Manufacturing department in a highly regulated manufacturing environment? Are you passionate about mentoring and developing...
-
Scientist for QC Change management Support
4 months ago
Hillerød, Denmark FUJIFILM Diosynth Biotechnologies Full timeAre you looking for an exciting new opportunity with a fast-growing company that values your work-life balance and well-being? Take this opportunity to manage change controls within QC with a friendly and engaging team, and enjoy a competitive salary, a flexible workspace with remote work options, on-site massage sessions, access to a modern fitness center,...
-
Hillerød, Hillerød Kommune, Denmark FUJIFILM Diosynth Biotechnologies Full timeThis is an exciting opportunity to lead a team of professionals in the Biological Drug Substance QA department at FUJIFILM Diosynth Biotechnologies. As a Team Lead, you will be responsible for enforcing TRUST with internal stakeholders and external customers through high compliance levels.The role involves leading, motivating, and prioritizing tasks for the...
-
Hillerød, Denmark Fujifilm Diosynth Biotechnologies Full timeFilling Technician for Drug Product Manufacturing (DPM) support Job Overview The Technical Support DP (Drug Product) team in Hillerød is a fast-growing team of highly skilled and experienced employees. We are endeavoring to ready our Hillerød Site for full aseptic filling capability. Join us as we introduce and implement a complete filling line. In 3-6...
-
GMP Supporter
19 hours ago
Hillerød, Denmark Novo Nordisk AS Full timeAre you passionate about maintaining the highest quality standards in pharmaceutical manufacturing? Do you get energy from having a large contact base and the possibility to work with highly qualified colleagues? Join our team at Novo Nordisk as GMP Supporter in Assembly in Hillerød and be part of our fantastic journey - apply today for a life-changing...
-
Dispensary Operators
2 days ago
Hillerød, Denmark Fujifilm Diosynth Biotechnologies Full timeDispensary Operators (Manufacturing Associates) for Drug Substance Manufacturing We are currently looking for operators for the Dispensary Department in Drug Substance Manufacturing (DSM) to support the biopharmaceutical production operations. FUJIFILM Diosynth Biotechnologies is expanding its capacity to support large-scale production by adding 14 x...
-
Customer Program Quality Manager
5 days ago
Hillerød, Denmark Fujifilm Diosynth Biotechnologies Full timeCustomer Program Quality Manager - Tech Transfer and Quality Agreements Customer Program Quality Manager - Tech Transfer and Quality Agreements Apply locations Hillerod time type Full time posted on Posted 30+ Days Ago job requisition id JR3645 Do you have QA experience from manufacturing (Drug Substance/Drug Product/Finished Goods)? Are you interested in...
-
Customer Program Quality Scientist
4 days ago
Hillerød, Denmark Fujifilm Diosynth Biotechnologies Full timeCustomer Program Quality Scientist Customer Program Quality Scientist Apply locations Hillerod posted on Posted 30+ Days Ago job requisition id JR3339 Do you have QA experience from manufacturing (Drug Substance/Drug Product/Finished Goods)? Are you interested in ensuring the right Quality level to our customers and keep them updated around the manufacturing...
-
Biotechnology Manufacturing Specialists
2 days ago
Hillerød, Hillerød Kommune, Denmark Fujifilm Diosynth Biotechnologies Full timeAbout the RoleFUJIFILM Diosynth Biotechnologies is expanding its capacity to support large-scale biopharmaceutical production by adding 14 x 20,000L bioreactors and three downstream processing lines in Hillerød. We are currently looking for operators to join our Dispensary Department in Drug Substance Manufacturing (DSM) to support the production...
-
Program Quality Manager for Manufacturing
5 days ago
Hillerød, Denmark Fujifilm Diosynth Biotechnologies Full timeProgram Quality Manager for Manufacturing (PQM MFG) Apply locations Hillerod time type Full time posted on Posted 30+ Days Ago job requisition id JR3329 Do you have QA experience from manufacturing (Drug Substance/Drug Product/Finished Goods)? Are you interested in ensuring the right Quality level to our customers and keep them updated around the...
-
Virology and Bioassay Senior Scientist
4 days ago
Hillerød, Denmark Fujifilm Diosynth Biotechnologies Full timeVirology and Bioassay Senior Scientist Virology and Bioassay Senior Scientist Apply locations Hillerod time type Full time posted on Posted 30+ Days Ago job requisition id JR3904 Do you have extensive experience with viral safety of drug substance manufacturing combined with bioassay expertise and are you eager to join a fast-growing pharmaceutical company?...
-
Senior QC Coordinator in Analytical Development
1 month ago
Hillerød, Denmark Fujifilm Diosynth Biotechnologies Full timeSenior QC Coordinator in Analytical Development Are you passionate about project management, have experience with Tech Transfer and are enthusiastic about contributing to a rapidly developing CDMO? Then we can offer an exciting and challenging job in a company with a very exciting future and many partners and products. We have great opportunities for...
-
Hillerød, Denmark FUJIFILM Diosynth Biotechnologies Full timeWe are expanding our large-scale facility to encompass 20 x 20,000L bioreactors for Drug Substance production. We are well in-progress on building our first Filling Facility in Denmark. Therefore, we are looking for people with “Genki”, which is one of our four values, it’s Japanese for passion, energy, and fun. We believe in teamwork, a variety of...
