Process Science Specialist for Biologics Development
4 weeks ago
About the Role
Lundbeck is seeking a highly experienced Subject Matter Expert (SME) to join our international Process Science team. As a Specialist/Sr. Specialist for Process Science, you will be responsible for downstream DS development, engaged through most of the project phases, including scale-up and technological transfer, clinical manufacturing, late-stage development, and validation.
Your Key Responsibilities
- Be a specialist in mammalian process development and manufacturing (downstream).
- Be an active member of CMC Biologics project teams and contribute to the progression of projects according to plans.
- Collaborate with our CMC Biologics Center of Excellence (CoE) in Seattle, US.
- Manage and work closely together with global CMOs, providing technical oversight to ensure projects are completed according to plans and fulfilling quality and regulatory expectations.
- Contribute to general technical, scale-up, and production strategies, including vendor selection and due diligence activities.
- Identify and drive areas for continuous improvement as it relates to manufacturing of biologics.
- Some travelling may be expected, approximately 1-2 travels abroad per year, to visit CMOs and/or to visit colleagues in CMC CoE in Seattle, US.
- Navigate various quality management systems as author and/or assessor.
About the Team
In CMC Biologics, we are a team of over 100 colleagues, split between Lundbeck Headquarters in Copenhagen and Lundbeck CoE in Seattle. Most of the CMC Biologics organization has employees based in both Copenhagen, Denmark, and Seattle, US. This is also the case for your new department, Process Science & Validation, which is split between the two sites.
Your colleagues are all experienced SMEs, and together you will cover DS late-stage development and clinical manufacturing for all Lundbeck biologics projects.
About Lundbeck
Lundbeck is a global pharmaceutical company dedicated to developing and marketing treatments for brain diseases. We strive to develop new innovative treatments to improve the lives of patients living with brain diseases. CMC Biologics supports the development and production of new biologics drug candidates for diseases like Migraine, Parkinson's, and Alzheimer's.
What We Offer
Lundbeck offers an inspiring workplace, passionate colleagues, and a culture characterized as collaborative. We are dedicated to bringing 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.
How to Apply
If you are a motivated and experienced professional looking for a new challenge, please upload your CV and include 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.
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