Scientific Lead - Drug Substance QP team.

Would you like to coordinate quality oversight and collaborate with various teams to uphold high standards in biopharmaceutical manufacturing?

And can you apply your scientific expertise to ensure drug substance batch confirmations are compliant and meet industry standards?

Then we hope you are our new Scientific Lead colleague!

Your New Role

Our work with many different biopharma companies means that we perform Drug Substance release (DS batch confirmation) for different programs and products.

You will take on a role as scientific lead of the delegated Qualified Persons (dQPs) in the QA DS QP team. The team has the responsibility of performing Drug Substance (DS) batch confirmation of clinical and commercial batches. You will coordinate the daily work within the group to ensure all requests are handled and all targets are met.

In collaboration with the delegated QPs, you will oversee that decisions are compliant with legislation and guidelines, consistent and scientifically sound, and that decisions are communicated to relevant stakeholders.
You will maintain the quality oversight for the QA DS QP team and ensure the plans for continued training of the delegated QPs. You will liaison with the operational QA DS teams, DS manufacturing Support, Process Science, and QC to align on the quality standards related to the DS manufacturing.

You will have close collaboration with the program management teams to align on quality related customer requests that require QP involvement both in initial program phases and during commercial production. You can expect to participate in customer meetings if quality related aspects for the QP team are on the agenda.

You are expected to continuously keep the QP on the license updated on any quality issues and concerns within DS manufacturing.

You will be the scientific lead of the delegated QPs without the managerial responsibility.

Your Primary Tasks Will Be:

• Developing and maintaining the quality standards for the DS manufacturing
• Balancing the internal quality standards with the customer requests and requirements and ensuring compliance to legislation and guidelines
• Responsibility for maintaining quality oversight within the QA DS QP team.
• Driving and supporting the continued training of the QP delegates
• Coordination and prioritization of the tasks in the team of delegated QPs in cooperation with the associate director of the QP team
• Participation in cross-functional teams to provide and ensure quality aspects are covered
• Participation in customer meetings to implement changes and/or improve processes
• Reporting of quality issues and concerns to QP on the license and quality leadership team

Your Skills & Talent

• Experience with Drug Substance manufacturing
• Expert knowledge in interpretation of legislation and guidelines
• The ability to make and communicate scientifically sound decisions based on legislation and guidelines, and apply these locally
• Previous experience as QP / delegated QP
• CMO experience is preferable
• Fluency in English

We hope you are

A curious team-player with a can-do attitude and excellent communication skills eager to learn and thrive in a very dynamic environment.

Your New Team & Department

You will be part of the QA DS QP team, headed by associate director of the QP team. Currently the team consists of 3 delegated QPs (adding 2 additional team members by end 2025) that covers release activities of DS manufacturing. We are on-site most of the week and sit together.

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

Has this sparked your interest? Then we urge you to please upload your CV and cover letter in English as soon as possible as we will be doing interviews on an ongoing basis. Should you have any questions, please feel free to reach out to Associate Director christina.schmidt@fujifilm.com

FUJIFILM Biotechnologies is a global leader in biologics contract development and manufacturing Organization (CDMO), partnering with innovative biotech and biopharma companies to transform healthcare. With locations in Denmark, the UK, and the USA, we support every stage of our customers’ product lifecycle, from breakthrough cures to life-saving vaccines.

 Our success starts with our people—their passion drives progress, innovation, and impact. Join a diverse, inclusive workplace that values collaboration, fosters growth, and empowers future generations. Together, we’re enriching communities, protecting the environment, and reimagining healthcare’s potential.

Shape the future with us—your drive meets boundless opportunity here https://fujifilmbiotechnologies.fujifilm.com/

 FUJIFILM Biotechnologies Denmark 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