Formulation Operator to Drug Product Manufacturing

Are you looking for an opportunity to join a growing pharmaceutical organization at a pivotal moment?

At FUJIFILM Diosynth Biotechnologies in Hillerød, we are entering an exciting phase where our Drug Product Manufacturing Facility is transitioning from project mode into full commercial operations.

You now have the chance to be a part of this journey and contribute to filling the facility with genki and purpose.

We are currently looking for a Formulation operator to support our Drug Product Manufacturing facility. You will play a key role in securing high-quality production by executing formulation processes in the DP area

Your Role:

As a Formulation Operator, you will be responsible for executing tasks related to formulation in compliance with GMP standards. You will also support batch preparation, documentation, review, and operational improvements, that ensure equipment readiness for production.

Your Primary Responsibilities:

• Execute Formulation processes in relation to our production plan and customer programs
• Documentation activities , ensuring compliance with Good Documentation Practices (GDP) and GMP.
• Support batch review and documentation, identifying possible deviations and suggesting improvements.
• Collaborate closely across DPM to optimize workflows and reduce downtime.
• Participate in Tech transfer activities, equipment qualification, process validation, and Aseptic Process Simulation (APS).
• Monitor and maintain cleanroom standards within the DPM facility.
Continuously contribute to improving safety, quality, reliability and efficiency within the department

Your Qualification:

We imagine you bring some of the following:

• A proactive and positive mindset , thriving in both independent tasks and teamwork.
• Experience as an operator within aseptic pharmaceutical manufacturing or similar GMP-regulated environment
• Strong understanding of GMP requirements, aseptic techniques, and cleanroom behavior.
• Flexibility to adapt to changing tasks and shift patterns as production ramps up.
• Ability to read, write and talk in English (SOP/WI/MBR are in English).

Working Hours:

• Initially, work will primarily be scheduled during regular daytime hours.
• As operations expand, we will transition into fixed shifts as operations requires.

The Drug Product Manufacturing department

The DPM Team will consist of approximately 80 dedicated people when the filling suite is ready for commercial production. DPM encompasses several teams: Shopfloor for Filling, Formulation, Visual Inspection, Wash and Autoclave, General Area Support, and Process Support. We value teamwork, development, and diversity, drawing from varied experiences and backgrounds to safely and swiftly deliver our medicines to market.

Our environment is international and informal, emphasizing psychological safety through trust and empowerment, a high pace, and a vital life balance with plenty of fun.

Application Process:

Please upload your CV and cover letter as soon as possible. We will review applications on a continuous basis. Deadline is the 12th of July.

For questions, contact Manager, Christer Flade at [email protected] (OBS vacation week 28,30,31,32)

The Company

FUJIFILM 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 Biotechnologies Denmark (FDBD) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability, sexual orientation, gender identity or any other protected class.

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.