Tech Transfer, Biopharma, CDMO, CMC
Black Swans Exist ApS
Copenhagen
We are supporting a biopharma CDMO that have a multiple incoming projects and expanding their Tech Transfer team. They have invested heavily into expanding their manufacturing capabilities over the last few years which also means several challenges around scaling their existing tech transfer processes.
This is a priority area within their company and the improvement work done is sanctioned from the senior leadership level. So you will be involved in some fairly high profile projects related to both clinical and commercial products from clients globally. It is also likely a position where you can find a solid career growth over the coming 3-5 years as few other companies are seeing similar levels of investments today.
If you are an experienced Tech Transfer Lead or CMC Project Manager then this is something we would be happy to discuss more in details.
Responsibilities:
- Act as the main technical contact for customers and internal regulatory teams.
- Develop project plans.
- Create and implement Process Performance Qualification (PPQ) strategies tailored to each project.
- Contribute to the establishment and implementation of global best practices for Technology Transfer and PPQ strategies.
- Support CMC activities in development and manufacturing.
- Identify and drive continuous improvement opportunities.
- Identify and escalate project risks while tracking progress against milestones.
Requirements:
- Masters Degree or above in engineering, chemistry, biochemistry or similar.
- 10+ years experience in the pharma/biopharma industry, especially related to CMC Process Development and GMP manufacturing.
- Project Management experience
- Fluent in English
If this sounds interesting, please apply and attach your CV. Alternatively you can reach out to Anders Sandberg at Black Swans Exist who is responsible for this recruitment process. Alternatively apply via LinkedIn: https://www.linkedin.com/jobs/view/4025219636/?eBP=NON_CHARGEABLE_CHANNEL&refId=qpfC5JZjOORvwUsYKgIfww%3D%3D&trackingId=ahi%2BwNTX4tBVEmCjoDMrXg%3D%3D&trk=flagship3_search_srp_jobs
Contact
If you want to hear more about this opportunity and the company, or if you have any questions regarding the position, please do not hesitate to contact us. If you wish to apply for the position, please send an updated version of your CV, together with what questions you might have, and we will get in touch with you soon.
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