QA Academic, CMC

Job title:

QA Academic, CMC

Company:

Lundbeck

Job description

QA Academic, CMCWould you 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 team collaborating with multiple stakeholders while leveraging your professional and personal competencies. We offer an exciting job with a broad variety in your 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 QA Academic 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:

• Batch record review (Biologics and Small Molecules)
• QA assessment of deviations, change controls and laboratory deviations
• Approval of master batch records
• Handling complaints
• Contribute to vendor oversight (e.g vendor re-evaluations)

You will collaborate with multiple stakeholders in CMC, and you will contribute to the continued development of our processes.Your future teamYou will join a new team headed by the Qualified Person. This team has a great opportunity to impact current ways of working and streamlining the 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 Biologic drug candidates including device activities. The majority of our manufacturing and QC activities are outsourced to CMO´s. You will be working primarily in DK time zone from our office in Valby.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, chemistry, biology, or similar qualifications
• Minimum 2 years of experience in a GMP regulated environment preferably in Manufacturing, Quality Control or Quality Assurance
• Sterile and biologic manufacturing knowledge is an advantage
• Knowledge and competencies within CMC are preferred
• You are fluent in English.

Our promise to youLundbeck 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 or by following us on LinkedIn or Instagram (@h_lundbeck).Apply nowCan 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 – Malene Brandt-Larsen, phone +45 31 70 59 53. Applications must be received by January 12th, 2025. 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 .#EveryBrainInTheGameThis 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.

Expected salary

Location

København

Job date

Fri, 06 Dec 2024 23:50:35 GMT

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