Process Supporter, Formulation, Drug Product Manufacturing

5 days ago

Hillerød, Denmark Fujifilm Diosynth Biotechnologies Full time

Process Supporter, Formulation, Drug Product Manufacturing

Process Supporter, Formulation, Drug Product Manufacturing

Apply locations Hillerod time type Full time posted on Posted 30+ Days Ago job requisition id JR3598

Do you have experience from Drug product manufacturing or aseptic manufacturing? Does introducing new products into a brand-new facility sound exciting to you?

Then come and join us and be a vital part of advancing tomorrow’s medicine in our new innovative Drug Product facility in Hillerød.

Your New Role

You will become part of an enthusiastic and dedicated team responsible for the formulation of our drug product. Together with your team, you will be responsible for the implementation of operational processes and procedures within the formulation area for DP.

The team will also be responsible for the design and creation of our electronic Master Batch Records for the formulation process.

During the next year, we will support the initial Aseptic Process Simulation (APS) and take part in introducing our first products into manufacturing. You will work in close cooperation with our many stakeholders to assure that we get all documentation ready for PPQ and subsequent manufacturing.

Subsequently, the team will support the daily operations in the formulation area and take part in Technology Transfer activities related to the introduction of new products from our partners.

Primary tasks will be:

  • Prepare/Update operational documents (SOPs and WIs).
  • Support creation of electronic Master Batch Records (PAS-X).
  • Participate and support activities related to initial and ongoing Aseptic Process Simulation (APS).
  • Participate in Tech transfer activities and implementation of new programs for our area.
  • Participate and contribute to Risk assessments related to ongoing manufacturing and new products.
  • First line supporting role for DP operation including training of colleagues.
  • Support handling of events and deviations.
  • Drive or support changes for our area.
  • Continuous improvements on e.g. flows of personnel, materials and equipment, CMRs and document updates.
  • Identification and implementation of corrective and preventive actions (CAPAs) to prevent re-occurrence and improve compliance.

Your Talent & Experience:

  • You have a bachelor’s or master’s degree within Pharmaceutical Sciences, Process Engineering, or similar degree.
  • Preferably, you have a minimum of 1-2 years of experience within aseptic manufacturing in the Pharmaceutical/Biotech industry. We can adjust the position according to your experience.
  • You can work independently on compliance-related tasks, events, and optimization projects.
  • You can manage multiple stakeholders and are motivated by the interface between QA, MSAT, and Manufacturing.
  • You understand regulatory requirements and can execute within their framework.
  • You have a high level of technical writing skills and excellent communication skills in English and Danish (spoken and written).

We hope you are:

Curious by nature, meet and greet people with a smile, and seek solutions when faced with a challenge or problem. You work with humility and respect for the people around you. You are flexible and able to prioritize tasks to meet defined timelines. You work structured with a quality mindset and enjoy cooperating as well as working independently.

Your New Team & Department

The Drug Product Manufacturing department will consist of approx. 60 dedicated and enthusiastic employees when the first filling suite is ready for production. DPM currently contains five teams covering Wash & Sterilization, Formulation, Filling, Inspection, and Compliance. We keep a high pace and focus on a vital work-life balance while having fun.

We believe in bringing different experiences and educational backgrounds into play, and the common denominator of the department is the acknowledgment and development of each employee.

We put a strong emphasis on psychological safety, trust, and empowerment within our teams and hope that this is something that speaks to you as well.

Application

Has this sparked your interest? Then we urge you to send an updated CV and cover letter as soon as possible. We will continuously invite relevant candidates for job interviews and will close the position as soon as we have found the right candidate.

If you have any questions, please do not hesitate to reach out to Hiring Manager Jacob Odgaard +45 22993134.

About Us

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.

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