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.
Lead and manage a senior scientific team of up to 5 Hcs, including experts in fields of oral formulation, pulmonary drug delivery, long acting and modified release dosage forms, solubilization and bioavailability enhancing technologies, formulation of
Lead key projects in mammalian cell line development, while spending the majority of your time (~80%) performing hands-on lab work; Mentor and support junior scientists within the team, fostering skill development and knowledge sharing; Contribute to the
As a functional expert within a small, innovative group, you will play a pivotal role in advancing our clinical development programs. In this highly collaborative environment, you will provide strategic guidance on pharmacokinetics (PK), pharmacodynamics
This role is pivotal in driving the global medical affairs strategy, ensuring alignment with cross-functional teams, and supporting the product's lifecycle management across multiple indications, including prostate cancer, central precocious puberty
In this role, you will coordinate and track regulatory submissions, partnering with the Regulatory Lead to prepare high-quality global submissions and ensuring timely delivery to health authorities worldwide. You will provide operational support to
In this role, you are providing medical strategic direction to the Dermatology Medical Affairs Teams, enabling successful execution of the medical components of the local strategic plans. You also provide strategic and scientific subject matter expertise