SGS_JOB_1306
Contract - 12 Months (Possibilities of Contract Extension)
The Quality Control Technical Transfer Analyst 3 will act as a team member of the Quality Control department to support production by contributing to the completion of the technical transfer activities. Also participate in quality testing for customer in-process, final product testing, and stability studies when needed.
The role “Scientific Publication Manager –Global Scientific Communications/Publications, Oncology” reports into the Global Medical Oncology team that is part of the Medical Specialty Care organization serving as a supporting partner to the Publications Lead. This role will work cross-functionally with commercial, regulatory, clinical, and market access on therapeutic solutions to support patients’ needs. Within our Global Medical Oncology team, we are committed to advance transformative therapies to help improve outcomes and impact the lives of people living with many different types of cancer. Global Scientific Communications/Publications, Oncology.
We are seeking a Marketing Automation Support professional to assist our client with various activities related to Email Marketing Campaigns, Personalization Campaigns, and A/B Testing using Adobe Marketo. The ideal candidate will have extensive experience in B2B marketing automation and a strong understanding of database management.
The Equipment Validation Specialist IV plays a crucial role in ensuring that all critical GMP equipment and systems are validated and maintained in compliance with user requirements, process parameters, and global regulatory guidelines. This position provides scientifically sound documented evidence to Operations, Quality Assurance, and regulatory bodies that systems and processes will perform as required, supporting a quality, compliant manufacturing environment.
The Equipment Validation Specialist is responsible for ensuring that all critical GMP equipment and systems are validated and maintained in compliance with user requirements, process parameters, and global regulatory guidelines. This role provides scientifically sound, documented evidence to Operations, Quality Assurance, and regulatory bodies, supporting a quality, compliant manufacturing environment.
The Analytical Validation Specialist III role focuses on supporting validation activities for analytical systems, such as software updates, new system introductions, and system decommissioning. This individual collaborates closely with senior specialists and other teams to ensure high-quality performance and compliance with industry standards. The role involves troubleshooting, executing qualifications, and supporting system changes while ensuring data integrity and quality systems adherence.
The QC Analyst II will support the Quality Control, Microbiology Safety Team by performing bioburden, microbial enumeration, endotoxin, sterility testing, and other microbiological assays. The role will assist with OOS investigations, maintaining laboratory equipment, and ensuring compliance with cGMP regulations. The ideal candidate will have experience with USP testing methods and a background in microbiology.
This role is to fill in for 4 months for a Clients’ Manager who is going on a Maternity leave. Minimum of 5 years of relevant experience Proven experience with regulatory submissions, including IND and CTAs Strong background in reviewing and editing regulatory affairs documents At least a Bachelor’s degree (with a heavy emphasis on hands-on experience) Additionally, the position will involve a panel interview as part of the selection process We are seeking a Manager, Global Regulatory Affairs, to work closely with the Global Regulatory Lead (GRL) for a given program(s).
This position involves conducting polymer synthesis, characterizing products, and supporting process improvements while adhering to safety and quality standards. The role requires strong lab skills, effective communication, and teamwork to contribute to research and production efforts.
Performs eCTD submission management across Biogen's product portfolio to Health Authorities for global development and lifecycle management submissions. The Regulatory Ops. Manager is responsible for the coordination of all publishing deliverables, in line with the strategic direction of their assigned programs/products. Oversee outsourced publishing deliverables on a day-to-day basis to ensure successful execution of operational activities for assigned products.
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