Responsible to provide effective technical leadership in achieving scientific excellence, planning, co-ordination and delivery of drug product development projects to meet business...
Play a key role supporting the BLA track of a late-stage drug substance (DS) manufacturing process at an external manufacturing partner (CMO) to enable process qualification and...
Have overall responsibility for providing medical, scientific, and strategic leadership for the successful planning, execution, and reporting of clinical trials. Additionally, this...
As a successful candidate, you will take the role of Team Leader In vitro Laboratory a team of 2-4 scientists engaged in drug discovery projects for biotech and pharma companies...
This position supports process development, regulatory interactions/submissions, and clinical and commercial manufacturing. The role also oversees early access and commercial label...
Develop and execute sound and robust global regulatory CMC strategies for biological products during early and late stage development, and lifecycle. Collaborate with cross...
You will oversee the planning, organizing, directing, and evaluating of routine external QC activities, including stability and project deliverables of external QC laboratories....
Contribute to the development of medical strategies to support brand commercialization activities by working closely with the global Medical Affairs and brand teams, Global Patient...
Develop and implement molecule characterization strategies; Work with team members to support process development teams with high-throughput analytical procedures; Utilize...
Improve team processes and systems for quality and delivery of work. Technical responsibility for all Research and Development activities assigned. Manage, schedule, costs/budget...
Develop and execute EU medical launch readiness plan for assigned products in neurology/psychiatry area. Support to clinical development with input on target product profile, based...
Engaging in high-quality peer-to-peer scientific dialog with key European Thought Leaders (TLs) in Neurology focused on pre- and peri-launch period. Collaborates with European...
Analysis of new chemical entities using analytical and preparative liquid and supercritical fluid chromatography techniques. Preparation of samples, reagents, solutions and...
Act as the quality lead for all Externally Sponsor Research, Non-interventional studies, Early Access Programs, Name Patient Programs and other non traditional clinical studies....
Developing a multi-year category strategy aligned with relevant stakeholders, recognizing the strategic importance of our External Manufacturing Operations portfolio; Implementing...
You are accountable for managing all analytic related activities of Drug Product development incl. release and stability-testing, characterization of the API, method-development,...
Le titulaire du poste a pour mission de participer au diagnostic, au traitement et à la prévention des maladies, ainsi qu'à la prestation de conseils, en effectuant ou en...
Do you have the skills and experience in quality documentation, auditing and process analysis required to play a critical role in fostering a “quality culture” within the...
This role is crucial in ensuring that our products meet the highest standards of quality and compliance, supporting our mission to improve the lives of diabetes patients globally...