- Genentech (South San Francisco, CA)
- …for patients at 50% less cost to society. **Key Responsibilities:** + Serve as a Contract Manufacturing Organization ( CMO ) Site Manager, organizing and ... overseeing the manufacturing outsourced portion of the Clinical Packaging portfolio. Contract Manufacturing Site Managers work closely with contract … more
- Gilead Sciences, Inc. (Foster City, CA)
- …worldwide regulatory requirements, including pharmaceutical ICH guidance + Understanding of the contract manufacturing organization ( CMO ) landscape ... through execution of manufacturing campaigns within our global external contract manufacturing network, while ensuring compliance with cGMP, regulatory… more
- Gilead Sciences, Inc. (Foster City, CA)
- …regulatory requirements, including pharmaceutical ICH guidance + Solid understanding of the contract manufacturing organization ( CMO ) landscape; ... through execution of manufacturing campaigns within our global external contract manufacturing network, while ensuring compliance with cGMP, regulatory… more
- Bristol Myers Squibb (Indianapolis, IN)
- … Manufacturing Quality Assurance is responsible for quality oversight of the Contract Manufacturing Organization ( CMO ) operations for ... in the pharmaceutical industry. + Hands-on experience with QA oversight of contract manufacturing organizations is highly desired, but applicable Quality… more
- Lilly (Philadelphia, PA)
- …Operations Associate is responsible for troubleshooting production issues with Commercial US Contract Manufacturing Organization ( CMO ) sites, assisting ... problems, providing technical input for production changes, and reviewing CMO investigations. **Responsibilities:** + Assist/Lead investigations into defects and… more
- Insight Global (Gaithersburg, MD)
- …Description This position will perform manufacturing oversight of an external contract manufacturing organization producing a Phase II/III clinical CAR-T ... This position will be responsible for working with the contract manufacturing organization to drive...-CliniMACS Prodigy Instrument Experience -CAR T experience is strong preferred -Previous partnership or working with CMO / EM… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …and governance models. + You have experience in the MaB, Large Molecule manufacturing environment. + Have negotiation and contract management skills. + You ... to fill a Senior Manager Global Procurement - Direct CMO position within our team. In this role you...contact for Global Procurement at the internal Drug Product Manufacturing facility in Tempel Lane. The role contributes and… more
- Astellas Pharma (Westborough, MA)
- …culture, auditing techniques, QC methods, HEPA filtration science, etc. + Experience with Contract Manufacturing Organization ( CMO ) oversight and ... and process performance qualification for AIRM/ MA-TC's cGMP Cell Therapy Manufacturing facility in Westborough, MA as products move through clinical trials… more
- Taiho Oncology (Princeton, NJ)
- …need for audits of TOI's, TOE's and vendors' systems. + Review and approval of Contract Manufacturing organization ( CMO )/ Contract Packaging ... needs of patients. Advanced technology, a world-class clinical development organization , and state-of-the-art facilities: these and other resources empower us… more
- Lilly (Indianapolis, IN)
- …people around the world. The position is responsible for working with Contract Manufacturer(s) (CM) and Original Equipment Manufacturer (OEM) to support, supply, ... sub-assemblies, and components that are supplied to Lilly packaging and manufacturing sites. The Lead Engineer ensures that equipment is in-control, compliant,… more
- Sanofi Group (Morristown, NJ)
- …delivering enterprise-wide value through innovative sourcing strategies and strategic Contract Manufacturing Organizations/ Contract Development ... communication and presentation abilities + Deep understanding of global pharmaceutical manufacturing and CMO landscape **Technical Knowledge:** + Expertise in… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …support to internal Regeneron audits + Provides expertise to the global External Manufacturing organization on cGMP compliance standard processes, as well as, ... communication and problem-solving skills + Possess experience interacting with Contract Manufacturing Organizations and leading in the Compliance/QA/QC… more
- Lilly (Indianapolis, IN)
- …related to the support of external manufacturing as defined in the Global Contract Manufacturing Standards. This role is the process expert for the step(s) ... to make life better for people around the world. ** Organization Overview** At Lilly, we serve an extraordinary purpose....of the product(s) and process(es) for each contract manufacturing relationship. This role is a… more
- Lilly (Indianapolis, IN)
- …agenda execution, and contract lifecycle management. + Continuously evolve Contract Manufacturing Standards to reflect commercialization dynamics and launch ... scaling with Lilly's expanding global footprint. + Build a high-performing global organization grounded in lean principles, manufacturing excellence, and joint… more
- Catalent Pharma Solutions (Harmans, MD)
- …Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral ... vaccines & hard-to-express recombinant proteins and oncolytic viruses. The Director, Manufacturing Fill Finish is responsible for leading teams and overseeing the… more
- Defense Contract Management Agency (Palmdale, CA)
- …may be filled from this announcement. Responsibilities Develop and implement Contract Management Office ( CMO ) Quality Assurance Engineering (QAE) standard ... operating procedures and QAE surveillance plan Develop CMO standard operating procedures that define how QAE policy...registration through a State Board's eminence provision as a manufacturing engineer typically would be rated eligible only for… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Foster City, CA.** **Knowledge:** + Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs). + Demonstrates in-depth knowledge of QA principles, ... compliance with applicable regulatory requirements. Ensures compliance with current Good Manufacturing Practices (GMPs). + Acts as an initial point of business… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Biopharmaceutical or Pharmaceutical experience a must. + Prior experience leading contract manufacturing /testing operations or overseeing contract ... Foster City, CA. **Job Functions:** + Primary Pharmaceutical Development and Manufacturing (PDM) Quality contact accountable for proactive quality oversight for… more
- Lilly (Indianapolis, IN)
- …Service Manufacturing Science function within the Drug Product External Manufacturing organization (DPEM). This role is responsible for all technical ... external manufacturing as defined in the Global Contract Manufacturing Standards This role is the...standard expectations and the continuous improvement strategy. Relationship with CMO + Make regular communication with and visits to… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …fill/finish, assembly, and packaging. + Technology transfer to both contract manufacturing organizations (CMOs) and internal manufacturing ... + Act as the SME for the Takeda combination products and device manufacturing organization . + Possess in-depth knowledge of combination products and device… more