FUJIFILM Diosynth Biotechnologies - Manufacturing Project Lead

Summary

We are looking for a Manufacturing Project Lead to join the DSM Project & Support team. You will join a team of 13 dedicated employees who perform manufacturing support through delivering OPEX projects, change management control of materials/items needed in production and general support to the Drug Substance Manufacturing organisation (DSM).

The role

In the role as Manufacturing Project Lead you are responsible for executing various OPEX tasks in different departments, leading changes of materials needed to be substituted in production and changes related to deviations.

The OPEX projects comprises replacement, change or introduction of new DSM equipment. This is followed by a thorough technical review and assessment of equipment impact on manufacturing processes and manufacturing capabilities.

Tasks:

• Execute OPEX projects in different departments across DSM.
• Planning and running change controls of required manufacturing material/task/projects.
• Defining tasks and projects through project tools templates or similar with DSM departments.
• Support with technical knowledge for updating and changes of general documents in DSM
• Perform EHS tasks, CAPA work and review of validation protocols.
• Introduction of new manufacturing equipment, items and procedures in DSM.
• Ongoing support and participation in Site CAPEX projects.

Qualifications and Education

• You have a Bachelor or Master’s degree within Engineering, Pharmacy or similar and a minimum of 2-5 years of relevant working experience in a cGMP environment e.g. biotech, pharmaceutical industry.
• You are an experienced Engineer or similar with analytical skills and supporter mindset. You have a successful track record in running changes across manufacturing regardless of complexity and magnitude.
• You are familiar with OPEX tasks in a manufacturing environment.
• In delivering your work and results you have gained experience and knowledge of databases, tools and systems (MS Project, Excel etc.) and solid experience in the execution of projects.
• Excellent English skills verbally and in writing and excellent oral and written communication skills, as you must be able to work cross-functional with multiple stakeholders.

• As a person you have a strong sense of urgency about solving problems, prioritizing and getting work done. You have good energy, you are proactive and you enjoy working in a dynamic and innovative environment with changing priorities.

What we can offer is that you can: 

• Broaden your process knowledge, create a network, improve your problem-solving skills and be able to work closer to the Management group. 
• Influence your position and the future development of the role according to business strategy. Be part of the future organisation needed for the 11 Billion DKK manufacturing expansion currently being undertaken at the Hillerød site.

Application

Please upload your CV and cover letter as soon as possible

e are reviewing applications on a continuous basis and urge you to apply as soon as possible, however delays in response time should be expected as we enter the vacation period.

Please note that all applications must be send through our career site:

https://fujifilmdiosynth.wd3.myworkdayjobs.com/da-DK/External/details/Manufacturing-Project-Lead_JR1650

For further details please contact William Hermanns +4581929161

About FUJIFILM Diosynth Biotechnologies

FUJIFILM Diosynth Biotechnologies, a subsidiary of FUJIFILM Corporation, is a world-leading contract development and manufacturing organization (CDMO) with experience in the development and manufacture of biologics, vaccines and advanced therapies. The company operates a global network with major locations in the Unites States of America, the United Kingdom and Denmark and it is building a new manufacturing site in Holly Springs, North Carolina, USA.

FUJIFILM Diosynth Biotechnologies has over thirty years of experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems. The company offers a comprehensive list of services from cell line development using its proprietary pAVEway™ microbial and Apollo™X cell line systems to process development, analytical development, clinical and FDA-approved commercial manufacturing.

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.

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.