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Biologics Process Science Specialist
1 month ago
Biologics Process Science Specialist
Lundbeck is seeking a highly skilled Biologics Process Science Specialist to join our international Process Science team. As a key member of our team, 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; in average, 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 Your Future Team
In CMC Biologics, we are more than 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 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.
What You Bring to the Team
You hold a Master or PhD in engineering, chemistry, biological science, or equal. In addition, you preferably bring 3+ years in Biotechnology or Pharmaceutical Development as well as experience from working with CMOs.
Furthermore, you have the following skills:
- SME knowledge about downstream DS development.
- Experience with DS clinical manufacturing.
- Desire to be working within cGMP requirements (regulations and guidelines) and cGMP quality systems.
- Fluently in English (Danish will be a benefit but is not a must).
- Good communication and stakeholder management skills.
- Experienced with working in an international setting with different cultures.
- A team player with a positive attitude, a can-do approach, structured, and good at planning own work.
- Manages ambiguity and thrives in a dynamic and changing environment.
Candidates fulfilling most but not all the listed qualifications are still encouraged to apply, as the position can be adjusted according to qualifications.
