Specialist in Downstream Drug Substance Development and Clinical Manufacturing for CMC Biologics at Lundbeck
3 days ago
Specialist in Downstream Drug Substance Development and Clinical Manufacturing for CMC Biologics at Lundbeck
Are you an experienced Subject Matter Expert (SME) with a passion for biologics process development and manufacturing? Do you want to join our international Process Science team at Lundbeck and contribute to the development of new treatments for brain diseases?
Your new role – why is this a great opportunity?
At Lundbeck, we are one of the only pharmaceutical companies in the world focusing exclusively on brain diseases. Our project pipeline is progressing well, and CMC Biologics is engaged in multiple high-priority projects in both early-stage and late-stage development.
In this role, you will be a SME in downstream drug substance development and clinical manufacturing. You will work in close collaboration 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).
The Position
As a downstream SME, you will work out of the headquarter in Valby, Copenhagen, and you will report to the Associate Director for Process Science in Seattle.
Your key responsibilities will include:
- Being a specialist in mammalian process development and manufacturing (downstream).
- Being an active member of CMC Biologics project teams and together with colleagues, contribute to the progression of projects according to plans.
- Collaborate 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.
- Contribute to general technical, scale-up, and production strategies including vendor selection and due diligence activities.
- Being able to identify and drive areas for continuous improvement as it relates to manufacturing of biologics.
- Some travelling must be expected; in average, 1-2 travels abroad per year, to visit CMO and/or to visit colleagues in CMC CoE in Seattle, US.
- Navigating 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.
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.
In Lundbeck, we strive to develop new innovative treatments to improve the lives of patients living with brain diseases. CMC Biologics support the development and production of new Biologics drug candidates for diseases like Migraine, Parkinson's, and Alzheimer's. Established CMC Biologics focus teams and working groups are responsible for the continued development of Lundbeck's Biologics candidates and are working into global project teams with representatives from R&D, Preclinical and Clinical Development, Regulatory Affairs, and Commercial.
To accommodate time zone differences between teams in Copenhagen and Seattle, we reduce late meetings via maintaining a primary meeting band in the calendar and via applying a geographical proximity, when working with our global CMOs.
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.
Our promise to you
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.
Apply now
Can you see yourself as our new colleague in the Process Science team?
Then 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.
If you have questions, please feel free to contact Meng Tseng, Associate Director of Process Science, on the appropriate contact channel.
Applications must be received no later than November 10, 2024, and application review and interviews will be conducted on an ongoing basis.
#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.
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