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Senior Compliance Specialist to Drug Product Manufacturing, Hillerød, Denmark

Do you have experience with compliance and aseptic production? Would you like to utilize your experience in a role where you provide support across our different compliance processes? Do you thrive in an outgoing role where you connect the specialized knowledge within the team to find the best solutions in cross functional tasks and projects? Then this could be your chance to add your footprint on our new Fill Finish facility in Hillerød!

Join us on our exciting journey

We are progressing on the construction and building of our world class Drug Product Filling Facility and soon the first equipment will be delivered onsite! Here we will have great opportunities for the right candidates to become a member of a totally new established Drug Product Manufacturing (DPM) team.

We are looking for team players, entrepreneurs and people who both like details and like taking greater responsibility beyond your scope of work.  We are looking for people with “Genki”, which is one of our four values and is Japanese for passion, energy and fun. We believe in teamwork, high degree of delegation, giving responsibility to those closest to the work. We believe in people!

Senior Compliance Specialist

As an experienced Compliance Specialist, you can already now join our Drug Product Manufacturing /Compliance team. You will participate in setting up the manufacturing operating structure, manufacturing processes, and preparing the extensive documentation package for qualification of the new facility as part of the North Star Drug Product project for afterwards transitioning into a more supporting role to the production. 

Primary tasks will be:

  • North Star project activities as execution of process qualification, aseptic process simulation, FMEA and draft Operational documentation  
  • Represent manufacturing during Tech Transfer activities and implement new processes in manufacturing for our customers.
  • Drug Product Manufacturing SME on Projects
  • Planning and execution of optimization projects and standards to ensure continuously improvement of Drug Product Manufacturing Processes
  • Identification and implementation of corrective and preventive actions to prevent re-occurrence and improve compliance.
  • Create and revise GMP documents eg. Master Batch record, SOP’s etc.
  • Drive Change Request and deviations

The Drug Product Manufacturing Team

The Drug Product Manufacturing Team will consist of approx. 45 dedicated and enthusiastic employees when the filling suite is ready for production. DPM will contain five teams covering Wash & Sterilization, Formulation, Filling, Inspection and Compliance. The common denominator of the five teams is the acknowledgement and development of each and every employee and the diversity of the employees who have different experiences and educational backgrounds but collaborate closely on getting our medicine safely and quickly to the market.

Our ambition is that the Drug Product Facility will be state of the art, with automated isolator filling line and inspection line. All process documentation and EM samples are being executed as per relevant operating procedures. The Filling Team is part of the Drug Product Manufacturing department within our Supply Chain which provides e.g. Drug Product filling services to our customers. The department continuously strives to identify opportunities to improve systems and practices to optimize and streamline our operation.

Your Talent 

You have minimum 5-7 years of GMP experience from the Pharmaceutical or Biotech industry. You have proven experience with project management, can work independently on compliance related issues, deviations and optimization projects. You are an expert in stakeholder management and is motivated by the interface between QA, Process Science and Manufacturing. You understand and are able to execute against regulatory requirements. Preferably you have experience from a Fill Finish facility within eg. Formulation, Visual inspection or Filling.

You have a high level of technical writing skills and excellent communication skills in English and Danish (spoken and written).

You have a Bachelor or Master Degree within Pharmaceutical Sciences, Proces Engineering or similar area.

As a person you are:

As a person you are curious of nature, you meet and greetpeople with a smile and have a can do attitude. You work with a humility and respect for the people around you. You are robust, flexibile and able to prioritize tasks to meet defined timelines. You work structured with a quality mind set and enjoy working independently and proactive in a dynamic entrepreneurial environment.

Application 

Please upload your targeted CV and cover letter:

https://fujifilmdiosynth.wd3.myworkdayjobs.com/en-US/External/details/Senior-Compliance-Associate-to-Drug-Product-Manufacturing_JR1293

We will screen candidates on a continuous basis and call in for interviews.

For further information or questions please contact Manager Christina Madsen +45 22200717.

 

About FUJIFILM Diosynth Biotechnologies

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.

Our site in Hillerød, Denmark, brings together expertise, capabilities and technologies to manufacture advanced biologics. The large scale manufacturing facility has a capacity of 120,000 liters to reliably manufacture biologics for late phase and commercial use. We commenced 6 billion DKK projects to double our manufacturing capacity and to add fill finish to the site.

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.

As we continue to enhance and expand our capabilities, we are looking for people who share our passion, drive, and energy – what we call Genki – to join our team.

www.fujifilmdiosynth.com

 

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Senior Compliance Specialist to Drug Product Manufacturing, Hillerød, Denmark

Do you have experience with compliance and aseptic production? Would you like to utilize your experience in a role where you provide support across our different compliance processes? Do you thrive in an outgoing role where you connect the specialized knowledge within the team to find the best solutions in cross functional tasks and projects? Then this could be your chance to add your footprint on our new Fill Finish facility in Hillerød!

Join us on our exciting journey

We are progressing on the construction and building of our world class Drug Product Filling Facility and soon the first equipment will be delivered onsite! Here we will have great opportunities for the right candidates to become a member of a totally new established Drug Product Manufacturing (DPM) team.

We are looking for team players, entrepreneurs and people who both like details and like taking greater responsibility beyond your scope of work.  We are looking for people with “Genki”, which is one of our four values and is Japanese for passion, energy and fun. We believe in teamwork, high degree of delegation, giving responsibility to those closest to the work. We believe in people!

Senior Compliance Specialist

As an experienced Compliance Specialist, you can already now join our Drug Product Manufacturing /Compliance team. You will participate in setting up the manufacturing operating structure, manufacturing processes, and preparing the extensive documentation package for qualification of the new facility as part of the North Star Drug Product project for afterwards transitioning into a more supporting role to the production. 

Primary tasks will be:

  • North Star project activities as execution of process qualification, aseptic process simulation, FMEA and draft Operational documentation  
  • Represent manufacturing during Tech Transfer activities and implement new processes in manufacturing for our customers.
  • Drug Product Manufacturing SME on Projects
  • Planning and execution of optimization projects and standards to ensure continuously improvement of Drug Product Manufacturing Processes
  • Identification and implementation of corrective and preventive actions to prevent re-occurrence and improve compliance.
  • Create and revise GMP documents eg. Master Batch record, SOP’s etc.
  • Drive Change Request and deviations

The Drug Product Manufacturing Team

The Drug Product Manufacturing Team will consist of approx. 45 dedicated and enthusiastic employees when the filling suite is ready for production. DPM will contain five teams covering Wash & Sterilization, Formulation, Filling, Inspection and Compliance. The common denominator of the five teams is the acknowledgement and development of each and every employee and the diversity of the employees who have different experiences and educational backgrounds but collaborate closely on getting our medicine safely and quickly to the market.

Our ambition is that the Drug Product Facility will be state of the art, with automated isolator filling line and inspection line. All process documentation and EM samples are being executed as per relevant operating procedures. The Filling Team is part of the Drug Product Manufacturing department within our Supply Chain which provides e.g. Drug Product filling services to our customers. The department continuously strives to identify opportunities to improve systems and practices to optimize and streamline our operation.

Your Talent 

You have minimum 5-7 years of GMP experience from the Pharmaceutical or Biotech industry. You have proven experience with project management, can work independently on compliance related issues, deviations and optimization projects. You are an expert in stakeholder management and is motivated by the interface between QA, Process Science and Manufacturing. You understand and are able to execute against regulatory requirements. Preferably you have experience from a Fill Finish facility within eg. Formulation, Visual inspection or Filling.

You have a high level of technical writing skills and excellent communication skills in English and Danish (spoken and written).

You have a Bachelor or Master Degree within Pharmaceutical Sciences, Proces Engineering or similar area.

As a person you are:

As a person you are curious of nature, you meet and greetpeople with a smile and have a can do attitude. You work with a humility and respect for the people around you. You are robust, flexibile and able to prioritize tasks to meet defined timelines. You work structured with a quality mind set and enjoy working independently and proactive in a dynamic entrepreneurial environment.

Application 

Please upload your targeted CV and cover letter:

https://fujifilmdiosynth.wd3.myworkdayjobs.com/en-US/External/details/Senior-Compliance-Associate-to-Drug-Product-Manufacturing_JR1293

We will screen candidates on a continuous basis and call in for interviews.

For further information or questions please contact Manager Christina Madsen +45 22200717.

 

About FUJIFILM Diosynth Biotechnologies

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.

Our site in Hillerød, Denmark, brings together expertise, capabilities and technologies to manufacture advanced biologics. The large scale manufacturing facility has a capacity of 120,000 liters to reliably manufacture biologics for late phase and commercial use. We commenced 6 billion DKK projects to double our manufacturing capacity and to add fill finish to the site.

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.

As we continue to enhance and expand our capabilities, we are looking for people who share our passion, drive, and energy – what we call Genki – to join our team.

www.fujifilmdiosynth.com

 

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