stakeholders. Requirements: Bachelor's degree in Life Sciences, Regulatory Affairs, Chemistry, or a related field. Advanced...
Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules. These submissions include health authority briefing packages, IND/CTA, NDA, and MAA regulatory filings. Prepare and review CMC submissio...
Responsibilities: Lead cross functional teams in complex engineering assignments, on a project-by-project basis. May cross traditional product lines. Independently plan, execute and direct cross functional engineering projects, that may...
Responsibilities: Strong analytical skills to synthesize business needs, manufacturing requirements, engineering elements, and technology inputs, etc. into business solutions. The ability to lead and/or support multiple projects simultan...
Responsibilities: Conduct evaluations and compliance walkthroughs of manufacturing and warehouse personnel and areas to ensure procedures are being followed in accordance with GMP compliance. Conducts real time batch record reviews in as...
Responsibilities: We are seeking a Senior Quality Engineer with a strong background in IV bag or IV solutions manufacturing to join our healthcare manufacturing team. The ideal candidate will have experience in a regulated manufacturing ...
Responsibilities: Work closely with operations and the business functions to ensure quality performance of products and processes. Initiation and ownership of NC and CAPA, builds proficiency in problem-solving and root-causing activitie...
Responsibilities: Work closely with operations and business functions to ensure quality performance of products and processes. Initiation and ownership of NC and CAPA, builds proficiency in problem-solving and root-causing activities. ...
Responsibilities: Responsible for the project management of key Clinical Supply Chain activities at the protocol level for and Phase I - IV clinical trials. Includes forecasting, planning, scheduling, coordination and execution, ensuring...
during internal and external audits and inspections. Requirements: Bachelors' degree, preferably in a life science or a related...