QP delegate Biologics, CMC

If you would like to contribute to the development of new treatments for brain diseases by ensuring patient safety and GMP compliant Investigational Medicinal Product (IMP) to clinical trials? Then this is a great opportunity to join our QP delegate team collaborating with multiple stakeholders while leveraging your professional and personal competencies. We offer an exciting job with a broad variety in you daily work ensuring compliance for CMC deliverables from early to late phase pipeline projects.

Your new role – why is this a great opportunity?
You will join a growing department with an exciting future ahead with expected upcoming purchase off new drug candidates. As QP delegate you will support the progression of our pipeline of promising drug candidates by ensuring patient safety and GMP compliance of the IMP for clinical trials.

Tasks:

• QA disposition of Biologic Bulk Drug Substance and Drug Product
• You will do the QP certification of IMP
• QA assessment of deviations, change controls and laboratory deviations
• Approval of master batch records
• Batch record review
• Handle complaints

You will collaborate with the Product Quality Leads on quality related issues and you will contribute to our continued development of the Quality Management System by authoring and approving SOP´s governing the activities.

Your future team
You will join a new team with 3 QP delegates, headed by the Qualified Person. The team has a great opportunity to impact current ways of working and streamlining the QP certification processes.

The CMC Development QA organization consists of approximately 20 employees based in Copenhagen and Seattle, US who together are responsible for efficient and compliant quality processes to support the development of Small Molecule and Biologics drug candidates including device activities. The biologic manufacturing and QC activities are outsourced to CMO´s.

You will be working primarily in DK time zone with app. 1-3 weekly online meetings in the timeslot from 16.00-18.00.

You will be part of a dedicated and collaborative team, and you will be collaborating with competent stakeholders across the CMC area all with the aim of developing new innovative treatments. We offer a unique position for you to build upon your experiences and professional development.

The job offers great opportunities to grow your competencies and knowledge and to widen your duties and responsibility as you develop in the role.

What you bring to the team

• You hold a master’s degree in pharmacy or similar qualifications to meet the requirements of a QP delegate
• Sterile and biologic manufacturing knowledge
• At least 5-10 years of experience in a GMP regulated environment preferably in Manufacturing, Quality Control or Quality Assurance
• Experience as a QP delegate is an advantage
• Knowledge and competencies within CMC is preferred
• You are fluent in English.

Our promise to you
Lundbeck offers an inspiring workplace, passionate colleagues and a culture characterized as collaborative – a must to successfully bring our treatments through research and development all the way to commercialization and the people who need them. We offer a mix of exciting tasks and numerous development opportunities that are balanced with initiatives focused on your well-being.

You can also learn more about us at www.lundbeck.com or by following us on LinkedIn or Instagram (@h_lundbeck).

Apply now
Can you see yourself in this role? We want to hear from you. Does this sound like your dream job, but you’re not sure if you meet all the requirements? We still want to hear from you!

Upload your CV and include a few lines about your motivation for applying. No separate cover letter is needed. We ask you not to include a photo or personal information that does not relate to your professional experience.

If you have questions or want to hear more, please feel free to contact Director, CMC Development QA – Charlotte Ullits Houlbjerg via phone +45 30 83 21 69. Applications must be received by August 1st 2024. Relevant candidates will be invited for interviews as applications are received.

We need every brain in the game – and that includes all brains and the different perspectives we bring to the table. At Lundbeck, we embrace the uniqueness of each employee, and we are committed to building a workforce that is as diverse as the people we serve. Read more about our commitment at www.lundbeck.com/global/about-us/our-commitment/diversity-and-inclusion.

#EveryBrainInTheGame

This job ad is intended for individuals seeking a career opportunity with Lundbeck. We engage with recruitment and search firms where needed on the basis of a written agreement, and we do not accept unsolicited requests of any kind. If you work as a recruitment consultant, you are kindly instructed to refrain from contacting Lundbeck or the hiring manager directly with suggested candidates. If you violate this policy, you do so at your own risk and for your own account, and Lundbeck will not assume any liability nor pay any associated fees resulting from such violation.

About Lundbeck
Lundbeck is a biopharmaceutical company focused exclusively on neuroscience, with more than 70 years of experience in improving the lives of people with neurological and psychiatric diseases.

As a focused innovator, we strive for our research and development programs to tackle some of the most complex challenges. We develop transformative medicines targeting people for whom there are few, if any, treatment options.

Our goal is to create long-term value and make a positive contribution to people and societies, everywhere we operate. We are committed to fighting stigma and discrimination, and we act to improve health equity for the people we serve and the communities we are part of.

About Lundbeck
Lundbeck is a biopharmaceutical company focused exclusively on neuroscience, with more than 70 years of experience in improving the lives of people with neurological and psychiatric diseases.

As a focused innovator, we strive for our research and development programs to tackle some of the most complex challenges. We develop transformative medicines targeting people for whom there are few, if any, treatment options.

Our goal is to create long-term value and make a positive contribution to people and societies, everywhere we operate. We are committed to fighting stigma and discrimination, and we act to improve health equity for the people we serve and the communities we are part of.