Responsible for supporting the execution of the global medical plan for the assigned product in collaboration with the rest of the global medical team, as well as supporting the necessary cross-functional workstreams, while adhering to the
Use all imaginable chemistry tools and methods to develop and optimize commercial process for selected drug substance route (photochemistry, biocatalysis, flow chemistry, electrochemistry, on-line analysis/PAT, high-throughput experimentation, structural
This individual will lead the organization to develop industry-leading analytical methods, analytical characterization packages, and control strategies to advance the manufacturing, conjugation, formulation, and process development for
Your mission is to ensure the smooth execution of strategically aligned research projects, drive scientific and technical excellence across the group, and support the continuous development of the Group Science & Technology. You will act as a key
You will directly assist the Business Development Director in meeting the strategic, scientific, therapeutic, and commercial needs of MPP. The role contributes to shaping MPP business development strategy through the in...
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
You will provide technical leadership and scientific expertise to support the commercial manufacturing of pharmaceutical products. This role is responsible for ensuring robust process performance, driving continuous improvement, troubleshooting technical
This role will be responsible for driving the management of our TTR amyloidosis franchise. This role will support and challenge country teams in tailoring the global strategy to the regional and local market specifics while maintaining global alignment;
Lead the development and execution of clinical pharmacology strategies for ground breaking small-molecule programs. In this pivotal role, you will directly influence key decision-making processes, support regulatory interactions, and help build a
Driving all aspects of purification process development, characterization, and technology transfer to cGMP manufacturing for hybrid and continuous processes; Serving as an internal technical resource for cGMP manufacturing and Process Design as well as a
Set the strategic direction to build the statistical and clinical unbiased evidence for all clinical phases (I-III), regulatory submissions, market access and life cycle management; Contribute in collaboration with all scientists in DEV to design the
The Global Regulatory CMC Lead develops and executes global regulatory CMC strategy for assigned Sobi assets in development, prepares CMC sections of IND/IMPD, MAA, NDA/BLA as well as assesses global filing strategy for post approval changes.
Quality Assurance & Control: Oversee testing of raw materials, manufacturing quality control, and product validation; Team Leadership: Manage and lead a team responsible for compliance and quality oversight; Regulatory Compliance Ensure adherence to
You will lead and manage the Medical Department ensuring that Clinical Trials are conducted such that subjects' rights, safety and wellbeing are protected and that the Clinical Trial data is reliable. You will assume Medical responsibility for Clinical
The successful candidate will lead a Biologics Engineering team and oversee biologic projects primarily focused on Inflammation. The core responsibilities include biologics design and optimization to enable discovery projects from conceptualization to
Provides leadership and oversight for multiple, complex clinical trials and programs, ensuring delivery of high-quality data and regulatory compliance. Spearheads collaboration with internal study teams and vendors to ensure clinical trial delivery meets
Responsible for providing end to end operational oversight of an oncology clinical trial, including site management, vendor and CRO oversight, monitoring activities, and ensuring trial execution in compliance with protocol, GCP, and regulatory
Ensuring strategic support is provided to Global Project Team (GPT) assignments and wherever necessary, takes the lead in ensuring procedural documents relevant to GPT as applicable, to relevant GxPs and capture the right level of regulatory importance.
Responsible for both Chemistry and Microbiology Lab Assets, ensuring that the Lab is advanced in its technologies while ensuring compliance and best practices are adhered to. The role ensures efficient and innovative technologies and ideas are being
This role is accountable for the vision, direction, and performance of the Bioanalysis and Immunoanalysis/Immunogenicity groups, ensuring the delivery of high-quality, regulatory-compliant data for pharmacokinetics, pharmacodynamics, and immunogenicity