Are you ready to step into therapeutic area leadership across global markets? Do you thrive at the intersection of science, partner collaboration, and medical affairs? Would you like to play a key role in launching innovative treatments while expanding
This role serves to provide leadership in the Quality Operations function to support and drive strategic initiatives, continuous improvement and management of the Quality Center of Excellence in cooperation with the Center of Excellence leads. This
You are responsible for leading a range of global regulatory activities, encompassing both strategic and operational responsibilities across drug development, registration, and postmarketing phases. This role offers the opportunity to work in close
In this exciting role, you will be part of a highly driven team responsible for developing innovative workflow solutions for the CliniMACS Prodigy® and Plus® platforms—from initial concept to market launch. These solutions enable automated, fully
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. The pharmacoepidemiology
Oversees the clinical feasibility assessment and strategic planning of clinical trial programs or studies. Executes on these global programs or studies in one or more assigned therapeutic area(s) from decision to start a clinical development up to the
You will be responsible for providing medical safety expertise for the benefit/risk assessment of products in clinical development, with a specific focus on our key biologic (Nemolizumab). This involves signal detection, risk management
Leads the development and delivery of clinical sections of trial and program level regulatory documents (e.g., Investigator’s Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)
Validate performance of new Agilent Automated Electrophoresis instrumentation and assays; Support quality of current products through corrective and preventative action (CAPA) investigations and continuous product improvement projects according to the
Host external audits in the EU region, demonstrating AbbVie quality management system compliance to external regulators for ISO 13485 and other country-specific device audits; Conduct internal audits to assess the compliance of AbbVie quality management
Provide expert advice on GVP compliance and regulatory matters, acting as quality partner to PV Operations (US/DK) and the EU QPPV. Author and maintain GVP Quality procedures and support implementation of new or updated GVP requirements.
Advise on and create early nonclinical safety screening strategy including data generation for the selection of relevant species to ensure smooth transition from discovery to IND-enabling studies. Design, development and oversight of nonclinical safety
Development and leading execution of the medical strategy that informs the practice of medicine ensuring key needs are met in alignment with global product medical and relevant brand strategy. Contribution to cross-functional stakeholder teams in shaping
In this role, you’ll provide global scientific and technical leadership, contribute to innovation strategies, and act as a thought leader - both within Lonza and the wider biopharmaceutical industry. Guide development of mammalian USP/DSP processes for
You will lead the development and execution of cutting-edge Chemistry, Manufacturing & Control (CMC) strategies, ensuring the highest standards of regulatory excellence across our diverse portfolio - from pharmaceuticals and medical devices to
In this global role, the Industrial Lead Drug Product will bring a strategic vision and leadership in the industrialization of our late-stage development and commercial products (NBE and NCE). You will develop cutting-edge industrialization strategies,
Act as key point of contact for TPM on all operational aspects - equipment, performance, cycle time, yield etc. Build solid relationships with first tier TPM’s and drug linker TPM’s to monitor manufacturing performance weekly through the application
Your main tasks will include the development and adaptation of single use accessories for the CliniMACS Prodigy and CliniMACS Plus systems. As the group leader, you will take on both technical and disciplinary leadership responsibilities for a dedicated
Responsible for all tasks and resources including cross functional co-ordination required to complete relevant QC microbiology activities within regulated environment in the required timeframe. Management of QC Microbiology team to carry out tasks.