In this position, you will be responsible for driving developability activities to support early and late-stage projects, with a strong focus on risk assessment and data-based decision making. You will lead and develop a small team of research analysts
Are you passionate about ensuring the highest standards of pharmaceutical quality and compliance? We are seeking a dedicated QA Senior Specialist to lead and oversee critical quality assurance activities within a dynamic, global environment.
The role will ensure that high quality product is manufactured in compliance with local and international regulations, and released and delivered according to the established forecasts, schedules, and cost planned. This position also manages
This person will join a fast-paced, collaborative, and multidisciplinary team to support purification process development at the bench and pilot scale for the advancement of low-cost biotherapeutics manufacturing. Experience with high throughput
Responsible for partnership to develop the strategy, lead the global execution of Managed Access Programs across all therapeutic areas. Provide strategic input, oversight and coordination to ensure a streamlined and efficient approach
Ensure efficient, compliant and timely management of CPP (Certificate of Pharmaceutical Product) submissions and legalization activities as central coordinating function within GRA; Provide transparent tracking, prioritization and status of workflows
Responsible for leading and managing pharmaceutical development projects of drug entities within Development Bioanalytics (DevBA) from various customers and in different pre-clinical development phases; Accountable
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