Director, Manufacturing Science

Would you like to join us on our mission to start up and get whole new Drug Product manufacturing units up running?

Are you an ambitious leader who have the drive to develop your team and the department and continuously strengthen your stakeholder relations?

Then we hope you will join our brilliant MSAT DP Team

Your New Role
As the Leader of the Drug Product MSAT (Manufacturing Sciences and Technology) department, you will oversee the successful delivery of projects and initiatives by both FTEs and contracted employees, ensuring alignment with internal and external customer expectations.

Your role involves driving and supporting the strategic development of capabilities and capacity within the Drug Product area, working in close cooperation with other relevant departments to achieve our goals.

You will be instrumental in defining and prioritizing critical strategic projects to enhance Drug Product manufacturing capabilities. These efforts will be aligned with the broader site and company strategies, in collaboration with Business Development and Manufacturing Operations.

In addition, you will guide the team in defining and implementing the Drug Product manufacturing strategy, ensuring alignment and collaboration with stakeholders from Manufacturing Operations, Quality, Regulatory, IT/Automation, and Supply Chain.

The team is responsible for leading Process Development and Process Changes and serves as Subject Matter Experts (SMEs) in Drug Product manufacturing, including Formulation, Utensil Washers & Autoclaves, Aseptic Filling, Isolators, Inspection Lines, Annex 1 CCS, and Bio Tracks as EM Monitoring Technology. Their work supports the safe and reliable production of both clinical and commercial products.

Main Responsibilities

• Provide Manufacturing Science, Engineering and Technology support for Drug Product internal commercial manufacturing at Site Hillerød for all partner programs, and support colleagues at our new Manufacturing site in Holly Springs
• Strong involvement in Technology Transfers and Launches of new programs / products until readiness for commercial manufacturing and securing handover to Line of Business
• Consulting customers from Early phases to commercial: Supporting / leading early design and development of Drug Product configurations and robust processes based on QRM and Design for Manufacturability
• Consulting customers from Early phases to commercial: Supporting / leading early design and development of new delivery systems and packaging configurations and robust processes based on QRM and Design for Manufacturability
• Responsible for specifying and selecting and implementing new manufacturing equipment and upgrades of existing. -Leading implementation and update / improvement of systems and equipment for handling serialization of Finished Goods
• Cross function collaborative and project team leadership assignment consistent with personal strategic, operational, and technical leadership

We’re Looking For

• Master’s Degree
• 10-15 years’ experience from Pharma / biotech in Manager, PM and SME roles
• Solid leadership experience preferably from international pharma / biotech company.
• Solid experience with project management
• A strong background in Pharma mfg. ideally in Assembly and pack and with high-volume automated mfg.
• Solid Experience within Risk management, DFM, Lean/Six Sigma, statistical process analytics
• Fluent in English.

We hope you are

• Ambitious and high performing with exceptional interpersonal and communication skills.
• Skilled in influencing behaviors, managing stakeholders, negotiating, and resolving challenges with calm, tact, and diplomacy.
• Prepared to take on a leadership role with a proactive approach, handling complexity and making independent decisions with clarity and confidence.
• Capable of providing clear guidance and decision-making on short notice, supporting department activities and projects.
  

Your New Team & Department
MSAT supports both activities in Hillerød and Holly Springs. As the process- and equipment’s- SME, we are close to the manufacturing departments and an active partner of complex problem solving and the continuous improvements activities. Even as specialists, we spent time on GoToGemba and are always eager to improve.

The work environment is international and informal. We keep a high pace and focus on a vital life balance while having fun. We put a strong emphasis on psychological safety through trust and empowerment within our teams and hope that this is something that speaks to you as well.

How to Apply:
Has this sparked your interest? Then please send us your resume and a cover letter detailing your experience and why you are the perfect fit for this role as soon as possible, as we conduct interviews on an on-going basis. Please do not hesitate to reach out if you have any questions to Vice President Christian Larsson +45 41946533

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.

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 identify 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

Location: FDBD Hillerod