- Gilead Sciences, Inc. (La Verne, CA)
- …technical leadership of process development , technology transfer, and process operations within a phase appropriate cGMP environment. + Responsible for ... introduction into the production lines. + Experience in pivotal stage purification process development , characterization, and implementation in GMP facilities. +… more
- PCI Pharma Services (Rockford, IL)
- …the following but other duties may be assigned. Leads and directs cleaning specialist and process reliability expeditor on daily initiatives and activities by ... shape the future of PCI. **Job** **Title:** **Lead Cleaning Specialist ** **Department/Group:** **Maintenance** **Location:** **Assembly** **1st shift** **Summary of**… more
- Merck (West Point, PA)
- …require routine interaction with business areas across the site such as Vaccine Process Research & Development , Global Clinical Supply, and Analytical Research & ... qualification/validation processes including periodic review. + Familiarity with Quality, cGMP , Safety & Environmental Policies and Procedures. + Familiarity with… more
- Actalent (Grand Rapids, MI)
- …Specialist oversees regulatory affairs activities for a contract development and manufacturing organization (CDMO), supporting sponsors and application/license ... Master Files, including amendments and annual reports. + Support business development due-diligence evaluations and contribute to new-business selection. + Develop… more
- Bayer (Berkeley, CA)
- …minds to make a real difference, there's only one choice.** **Production Specialist II-CSI** Responsible for clinical manufacturing of novel cell therapy drug ... product within the Cell Therapy Module, CT-MOD. Collaborates closely with biological development (BD) and Manufacturing Science and Technology (MSAT) for new product… more
- Genentech (Hillsboro, OR)
- …is part of the Pharma Individualized Medicines Team responsible for the process development , manufacture, and supply of personalized immunotherapies in ... collaboration with our global partners. **The Opportunity:** As a **Materials Specialist ,** you are responsible for the execution of product logistics in a cGMP … more
- Kelly Services (Rockville, MD)
- …filling equipment in Grades A/B cleanroom + Support tech transfer and process development activities + Assist with deviation investigations, documentation ... **Associate Specialist - Cell Therapy Manufacturing** **Pay Rate:** $25.00...operation, and GMP practices + Collaborate with cross-functional teams ( Process Development , QA, Clinical Ops, etc.) +… more
- Curia (Rensselaer, NY)
- …one or more core validation areas (Equipment qualification, packaging, cleaning, utilities, process or computer validation) + Expert in cGMP documentation ... Senior QA Validation Specialist - CSV Systems Engineer Summary: The Senior...and projects that support the site + Support protocol development and approval, investigations for deviations and champion local,… more
- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve ... If completed by an external company, the computer systems validation (CSV) specialist will be responsible for obtaining these documents prior to developing the… more
- Boehringer Ingelheim (Athens, GA)
- …to the compliance effort and is responsible for assuring compliance of validated systems, process , equipment to current cGMP , FDA, EU, USDA, BIAH and BI ... an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development , and delivery of our products to our patients and customers. Our… more