Lead and execute MSAT projects such as manufacturing process and cost improvement as part of LCM; Participate in internal activities related to (external) manufacturing such as process changes, major/critical deviations, risk assessments and CAPAs;
Responsible for establishing and execution of work plans for their protein science area. Accountable for protein science project delivery from early drug discovery projects in their area of expertise, across modalities and therapeutic areas
You will provide senior statistical leadership across clinical and translational programs. This is a hands-on, high-autonomy role with strong matrix leadership: you will shape quantitative strategy, guide study design and analysis oversee complex
Own and drive the site’s sterility assurance strategy. This role ensures compliance with global regulatory requirements and serves as the SME for contamination control, aseptic processing, and sterilization validation. Review sterilization validations
Accountable for leading an injectable analytical group: developing, validating methods, characterizing structures of peptides and complex injectables with state of the art techniques. Preparing technical reports to demonstrate structural and impurity
In this pivotal role, you will design and execute the innovative data strategy that underpins our clinical development pipeline, ensuring the highest standards of scientific rigor and regulatory compliance across all trials and study phases fundamental to
Leads and handles all Quality & Compliance related programs supporting manufacturing, testing and release. This includes the clinical and commercial manufacturing and testing in full compliance with all J&J and governmental environmental, health, safety,
You will lead the design and execution of the global medical strategy for highly specialized assets with significant unmet medical need. You will play a key role in shaping the clinical and scientific narrative, enabling evidence generation, and building
Manage day-to-day laboratory activities for assigned formulation projects, providing guidance and support to scientists to ensure high-quality scientific delivery. Ensure laboratory practices comply with SOPs, quality standards, IOPs, and Health & Safety
The role leads the site's independent Quality Assurance organization, accountable for an effective, risk based Quality system. The role is responsible for inspection performance/readiness activities, data integrity and accountable to ensure final batch
Serve as an expert in drug development capable of advising on strategic decisions and directing resources. Build relationships with external parties relevant to ExploR&D development. Drive global solutions with the broader ExploR&D team and business
Responsible for leading regulatory strategies and operations to support the development, registration, and lifecycle management of Assigned Almirall’s pharmaceutical products across global markets. This role ensures regulatory compliance, drives
Lead the multidisciplinary Clinical Team at development-program level, providing scientific direction, strategic alignment and accountability across the program. Shape innovative clinical development strategies that maximize the compound's value
Responsible for leading day-to-day quality control laboratory operations and ensuring effective support for QA, Technical Service, and Production in line with site schedules and targets. This role supervises a team of QC Chemists reports to the QC
The position is responsible for leading international (non-North America) Scientific Communications within Medical Affairs, overseeing the development and delivery of high-quality scientific and medical content for approved and investigational products.
The role is responsible for ensuring Gilead’s medical affairs activities comply with pharmaceutical regulations and laws and providing expertise on drug safety and medical topics. Provides medical expert advice to ensure accuracy of data to support
Acts as a subject matter expert and escalation lead for complex quality issues, inspection readiness, and quality risk management, and ensures consistent, compliant and inspection-ready execution of quality activities across projects vendors, and systems,
Support late-phase clinical development by translating scientific and clinical strategy into actionable execution across clinical trials. The Clinical Scientist serves as a key clinical development team member, providing hands-on oversight of protocol
In this role, you will support Servier’s research pipeline by contributing to strategic data management projects, ensuring that our preclinical data is a trustable asset for life-changing therapeutic innovation. Ensure data integrity within your
Lead CMC submission management process by providing knowledge of CMC regulatory requirements, including a comprehensive knowledge of ICH CTD and evolving global agency standards, of CMC RA submission processes electronic submission regulations and
Root cause analysis (RCA) and CAPA implementation for project topics, and general lab topic. Investigation and management of deviations, as Lead Investigator. Quality oversight and audit readiness in GMP-regulated labs (participation in audits for