In this role, you’ll be responsible for overseeing the scale-up of fermentation processes from lab to commercial scale, and you will be instrumental in leading our plant start-up...
ProQR is looking for a nonclinical subject matter expert with experience in GLP toxicology studies according to regulatory guidelines. The candidate will play an essential role in...
You will manage PV staff and provide oversight to PV activities, workflow, processes, and procedures. You are also responsible for clinical PV (CPV) and post-marketing PV service...
Engages strategically and cross-functionally to step up country delivery and performance with, amongst others, Site Identification, Site Contracts, Site Payments, Site Activation...
You will manage uninterrupted supply of Gilead’s clinical and commercial products through execution of manufacturing campaigns within our global external contract manufacturing...
You own your assigned projects, are responsible for the projects progress and ensures that everything required to make it happen is available and/or performed. You communicate with...
Executing and managing all tasks of the MS&T organizational unit. Improving existing production procedures with the aim of achieving better results, increasing robustness, and...
Design, plan, perform and document scientific experiments as well as analysis and interpretation of the results to drive development and validation of analytical methods for solid...
You will be responsible for providing leadership and directions to the Safety Medical Sciences business functions and other assigned business functions, as well as provide...
You will possess strong skills in physico-chemical methods related to H/UPLC and CE method development and qualification, large molecule (mAbs) characterization, a mentoring team...
You will oversee batch release quality and compliance across internal sites and third-party maufacturers, ensuring all products (pharmaceutical and non-pharmaceutical products)...
Drug product development according to assigned project workpackages and in alignment with project strategy, objectives and timelines; Leading of Drug Product (DP) development...
You lead CMO vendor teams for daily operational management and coordinate meetings with UCB multifunctional teams; You participate in CMO selection for new and existing products,...
Provide regulatory support for existing Drug Substances and Drug Products by preparing and maintaining the appropriate regulatory submission documentation needed to obtain...
Co-ordinate experiments with CRO’s; Review, interpret and report data in support of drug discovery projects; Present data at multifunctional project teams; Work collaboratively...
He/she drives internal and external efforts with the aim of developing, producing and characterizing these therapeutics antibodies for early and late stage clinical programs up to...
The activities of your team will concentrate on the identification of novel therapeutic concepts in immune regulation and tolerance with the potential to lead to transformative...
You will oversee technical and business operations at designated external manufacturing sites, serving as the primary point of accountability for strategic and tactical activities...
Manage the QMS, ensure the QMS is fit for purpose, making changes as necessary approving SOPs and Quality System documents; Maintain Quality processes in support of BLIL...
Design and lead innovative research projects that address key scientific questions; Develop international grant proposals and lead collaborative research programs...
She/He will lead the EMEA medical community providing medical guidance and expertise across organization and externally. Define the EMEA medical strategy in close collaboration...
QA responsible for quality decisions in relation to batch manufacturing of Biological Intermediates (BI), Chemical Intermediates (CI) and Drug Substances (DS), in collaboration...
You are responsible for leading and coordinating the outsourcing of drug substance development and manufacturing activities. This critical role ensures optimal supplier...