Analytical Transfer Support, Biologicals
The Biologics Pilot Plant (BPP) and the Analytical Science for Biologicals (ASB) departments are supporting the transfer of drug substance manufacturing processes and analytics to commercial facilities. These tech transfers are involving multiple different stakeholders within UCB Pharma. The analytical transfer support will reinforce these transfer projects to allow on-time delivery of all the required documentation and deliverables.
The mission includes primarily, but is not limited to, the following responsibilities:
Collect, process and display analytical data.
Interact with multiple SMEs, centralize and compile various analytical risk assessments into presentations and reports (fit for purpose risk assessments, In process control risk assessments).
Organize (design and planning) the required experiments to demonstrate analytical fit for purpose of in-process analytics within the scope of process validation supporting studies.
Drive autonomously the review and the approval of documents to meet projects deadline
Specific professional/technical expertise and key skills required:
Able to write analytical method validation documentation.
Able to write/review various tech transfer documents: risk assessments, reports, protocols, certificates of testing, etc.
Able to drive deviations (Trackwise).
Experience with Veevavault Source Controlled Documents.
Organized and systematic mindset.
Able to learn quickly and integrate large amount of information.
Excellent communication skills, as interacting with different teams/stakeholders is crucial: CMOs, operators, production managers, process development scientists, development and commercial QA representatives, …
Fluent in English and French, both spoken and written: the documents to write/update are all in English.
Team player and experienced to work interactively with various stakeholders.
Excellent time-management skills, and experienced to work pro-actively to achieve given milestones and objectives
Autonomous, entrepreneur, able to work under limited supervision
Experienced to deliver to defined target dates and able to cope with time pressure
Flexibility to adapt to moving timelines
Increased tech transfer workload, implementations of lessons learned from first manufacturing campaigns and technology transfers.
Hours per week:
8 hours/day, 5 days per week; Time – indicatively from 09:00 to 18:00.
Duration of the assignment:
Initially 9 months, option for extension to 12 months
Start date (est.):
As soon as possible
Reports to the BPP IPC Manager/ASB Manager.
On site assignment: the contractor must be on site every working day.
Equipment: The assignment involves primarily office/desk based work.