Process Supporter, Formulation, Drug Product Manufacturing

Do you have experience from Drug product manufacturing or aseptic manufacturing? Does introducing new products into a brand-new facility sound exiting 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 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 of introducing of 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 of Technology Transfer activities related to introduction of new products from our partners.

Primary tasks will be:

• Prepare/Update operational documents (SOP’s and WI’s).
• Support creation of electronical 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.
• Fist line supporting role for DP operation including Training of colleges.
• Support handling of events and deviations
• Drive or support changes for our area.
• Continues Improvements on e.g. flows of personnel, materials and equipment, CMR’s and document updates.
• Identification and implementation of corrective and preventive actions (CAPA’s) 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 is 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 of nature, meet and greet people with a smile and you 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 mind set 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 acknowledgement 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

Location: FDBD Hillerod