Tech Transfer Lead / Technical Product Lead
FUJIFILM Diosynth biotechnologies in Hillerød is looking for an experienced Tech Transfer Lead /Technical Product Lead to join the Program management and Technology Transfer organization.
Program management and Technology Transfer is an organization embedded in the Process Science (PS) organization which is a department that provides scientific leadership to support clinical, PPQ and commercial processes in large scale Cell Culture manufacturing, Assembly, Label and Pack (Finished goods) and within a few years Drug Product as well.
Program management and Technology Transfer is a core function within PS. We are a growing team of 6 highly professional dedicated program managers and Technology Transfer leads with broad experience within pharmaceutical development and manufacturing of mainly mAb’s.
We lead Technology Transfers (TT) including the teams and as Technical Product Leads (TPL) maintain an overview of TT progress and at the same time look out for process compliance to filings, (CMC). We continuously strive to identify opportunities to improve systems and practices, and provide direction to our manufacturing group as well as technical development teams and our customers.
The work environment is informal, where we strive to have a lot of fun, while we keep a high pace.
The Tech Transfer Lead / Technical Product Lead is a critical role within FDBD as the business is in expansion and we introduce new programs and customers continuously.
Your main responsibilities
- Manage Technology Transfer activities for clinical/PPQ and commercial products into large scale manufacturing facility
- Develop PPQ strategies specific for different programs for large scale
- Develop projects plans that integrates with other scheduling functions within the organization
- Ensure cross functional communication to key stakeholders for any given project/task and that input are received
- Work in conjunction with key stakeholders/project team/s to develop and gain agreement on metrics
- Implementation of continuous improvements
- Proactively informs the Program Manager of milestone progress and any upsetting program delays
- Coordinate and lead regular planning with key stakeholders
- Ensure project execution is performed in compliance to existing procedures
- Ensure deliverables from process leads (e.g. Process Validation reporting) to regulatory filings. Communicate review and approval timelines to management
- Support CMC activities for development and manufacturing and as required per the program Supports the technical team to investigate any project challenges with necessary risk assessment tools and techniques.
- Execute on and support process trending and continued process verification plans. Review and document process performance and product health through process trending, monitoring, and supporting annual product reviews
- Serve as the technical and manufacturing SPOC (single point of contact) for the product both internally and to external partners once the product is commercialized
- Work with leaders from other commercial products and customers to continuously improve lifecycle management and tools
- Is part of the link to the customers or internal regulatory team for technical aspects of the process/program
You have a Master degree in Biochemical or Chemical Engineering or a BS/BA in a scientific or engineering field. You have a minimum of 5-7 years relevant pharmaceutical or biotech industry experience in CMC process development and/or GMP manufacturing. Furthermore you have 2-3 years of experience with Project management, preferably as Tech Transfer or CMC Project Manager.
You can demonstrate successful Project Management skills and you have a solid understanding of Biopharmaceutical manufacturing and GMP (Experience in either Cell Culture and/or Protein Purification). You have the ability to evaluate complex matters and identify key stakeholders. You pay attention to both the detail and the bigger picture. You are a high performing team player, ambitious on behalf of yourself and the company. You have the ability to balance between speed of execution and quality of work
For more information about the open position, please contact Ass. Director Program Management Jacob Jensen at +45 91357142
We are reviewing applications on continuous basis and urge you to apply as soon as possible.
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 large scale manufacturing facility in Hillerød has a capacity of 120,000 liters to reliably manufacture biologics for late phase and commercial use. The facility for medical device assembly, labeling and packaging manufactures advanced delivery systems and ensures required labeling and secure packaging of the therapies for patients worldwide. The site also houses quality control laboratories, warehouses, and a number of organizations, supporting the manufacturing activities: process science, supply chain management, engineering and quality assurance. 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.
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.