Process Science Specialist

3 weeks ago

Copenhagen, Copenhagen, Denmark Lundbeck Full time

Role Overview

Lundbeck is seeking a highly skilled Process Science Specialist to join our international Process Science team. In this role, you will be responsible for downstream DS development, engaged throughout most project phases, including scale-up and technological transfer, clinical manufacturing, late-stage development, and validation.

As a SME in mammalian process development and manufacturing, you will work closely with colleagues across the organization, as a member in our multidisciplinary project teams, and in close contact with our network of Contract Manufacturing Organizations (CMOs).

Your key responsibilities will include:

  • Being a specialist in mammalian process development and manufacturing (downstream)
  • Active participation in CMC Biologics project teams and contributing to the progression of projects according to plans
  • Collaboration with our CMC Biologics Center of Excellence (CoE) in Seattle, US
  • Managing and working closely together with global CMOs, providing technical oversight to ensure projects are completed according to plans and fulfilling quality and regulatory expectations
  • Contribution to general technical, scale-up, and production strategies, including vendor selection and due diligence activities
  • Identification and driving of areas for continuous improvement as it relates to manufacturing of biologics
  • Expected travel, approximately 1-2 times a year, to visit CMO and/or to visit colleagues in CMC CoE in Seattle, US
  • Navigation of various quality management systems as author and/or assessor

This position is a great development opportunity where you will be part of defining future manufacturing strategies of biologics within Lundbeck and work in an exciting interphase with various internal and external stakeholders.

Requirements

To be successful in this role, you will hold a Master or PhD in engineering, chemistry, biological science, or equal. In addition, you preferably bring 3+ years of experience in Biotechnology or Pharmaceutical Development as well as experience from working with CMOs.

You will also have the following skills:

  • SME knowledge about downstream DS development
  • Experience with DS clinical manufacturing
  • Desire to work within cGMP requirements (regulations and guidelines) and cGMP quality systems
  • Fluency in English (Danish will be a benefit but is not a must)
  • Good communication and stakeholder management skills
  • Experience 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
  • Ability to manage ambiguity and thrive in a dynamic and changing environment

Candidates fulfilling most but not all of the listed qualifications are still encouraged to apply, as the position can be adjusted according to qualifications.

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