manufacturing equipment such as the autoclaves to prepare for GMP processing. Maintains records and clean room environment... requirements, cGMP, SOP and manufacturing documentation. Use of automation to perform production operations. Provide support...
Title: Manufacturing GMP Support Duration: 24 Months Location: South San Francisco, CA (94080) Shift: Night shift... Aseptic medical evaluations Operate and support manufacturing equipment such as the autoclaves to prepare for GMP processing...
. We are looking for a Sr. Manufacturing Engineer who will be responsible for manufacturing engineering functions to facilitate production... by engaging in design for manufacturing (DFM). Manage/execute manufacturing cost reductions and quality improvement programs...
Assurance. Ensure consistency with Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) standards... Quality Indicators (KQIs). Support for Regulatory Inspections: Facilitate preparation, support, and process improvements...
controls, deviations, and CAPAs. Act as Alector's representative during vendor manufacturing operations. Ensure GMP vendors... (IP) to clinical sites and support QP release in compliance with regulatory filings. Conduct CMO/CDMO site visits for GMP...
operations supporting the GMP functions in ADQC and partially gRED. The Opportunity This role will support multi-disciplinary... Control (ADQC) organization within Pharma Technical Development, US (PTDU). As a GMP department, PAC-QC is responsible...
therapy manufacturing processes. The position requires a highly motivated and tenacious, self-starter who can assimilate new... and qualification, and preparation for non-GMP activities. Resolve project team issues and facilitate decision making within the team...
Work Schedule First Shift (Days) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety... and therapies or increasing efficiency in their laboratories, we are here to support them. Our team of more than 100,000 colleagues...
and manufacturing teams to ensure assay performance in GMP environments Develop and oversee the potency control strategy for late... of validated methods to Quality Control (QC) and/or external testing laboratories. Provide technical support to QC...
to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume...) to develop contamination control strategy and aseptic process manufacturing control. Provide support to site Safety initiatives...
deliverables * Transfer processes to GMP manufacturing Work with contract labs and carry out viral clearance studies Write..., you will apply your strong expertise in CMC purification to develop robust, phase-appropriate processes for drug substance GMP production to enable human...
experience in: MSc or PhD Experience supporting early or late-stage clinical programs and/or GMP manufacturing. The salary... client’s ongoing and future programs. Coordinate and align with Aldevron’s inside sales and technical support teams...
deliverables * Transfer processes to GMP manufacturing Work with contract labs and carry out viral clearance studies Write..., you will apply your strong expertise in CMC purification to develop robust, phase-appropriate processes for drug substance GMP production to enable human...
Automation team that provides technical support to ensure the safe, efficient and reliable operation of automation systems owned... and system applications. This includes BAS (Siemens Desigo CC), data historian (Aveeva Pi), server infrastructure and other GMP...
), server infrastructure and other GMP assets. Customer Support: Work closely with Site Operations customers to proactively... of the Site Automation team that provides technical support to ensure the safe, efficient and reliable operation...
of laboratories providing an unparalleled range of testing and support services to the biopharmaceutical, food and environmental... industries. The Eurofins BioPharma Product Testing (BPT) Group is the largest network of harmonized bio/pharmaceutical GMP...
. It is also the first GMP manufacturing platform to provide in vitro transcription (IVT) template linearized plasmids... CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy. GenScript...
will provide escalated support for Facilities Operations, EMS System Administration, CMMS system implementation and administration..., provide quality documents as it pertains to Facility GMP Equipment Functions/ Operations. The Facilities Engineer...
to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio... Technician I role, you will provide cage wash, general husbandry and/or investigative support following established protocols...
is to develop safe, innovative and effective drugs using cutting edge technologies for manufacturing process (Drug Substance... processes from development to commercial manufacturing while upholding the highest standards of safety, compliance...