- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** **Key Responsibilities** Senior Manager , Global External Manufacturing Biologics supports uninterrupted ... represent manufacturing on one or more cross-functional Development or Commercial CMC teams with responsibility for proactively managing product strategy across the… more
- Amgen (Thousand Oaks, CA)
- …and transform the lives of patients while transforming your career. **Process Development Senior Scientist** **What you will do** Let's do this. Let's change the ... such as Drug Substance Technologies, Drug Product Technologies, Product Quality, Regulatory CMC , and Supply Chain. The successful candidate will actively chart the… more
- AbbVie (North Chicago, IL)
- …campaigns and manage process orders and shipping. + Collaborates with the materials manager , program manager , and/or team lead to set expectations for ... written and oral). Key Stakeholders: Project team members from development, analytical, CMC and QA Coordinators from other Operations/sites Supply Chain and tech… more
- GE Aerospace (Huntsville, AL)
- **Job Description Summary** The Production Manager has direct responsibility for operations personnel and is accountable to drive unit performance in safety, ... weight and high-temperature resistance. GE Aerospace has been at the forefront of CMC development since 2001, with successful implementation in engines like the LEAP… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.) to develop global regulatory ... plans, address global regulatory issues, health authority queries, and regulatory obligations. - Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs… more
- US Tech Solutions (Thousand Oaks, CA)
- …experience in the Pharmaceutical, Biotechnology or other Healthcare related field, direct CMC experience is highly desirable + Ability to foster collaboration and ... work effectively on cross-functional teams + Strong interpersonal and communication skills with the ability to effectively interface across all levels of the organization + Critical thinking and problem-solving skills + Apply standard Project Management tools,… more
- ThermoFisher Scientific (Morrisville, NC)
- …experience in Pharmaceutical Industry, including Manufacturing, Quality Control, Quality Assurance, CMC , Regulatory or related compliance experience with at least 5 ... years aggregate experience performing audits for GMP, ISO or ICH, and hosting/supporting FDA, EMA, MHRA, AIFA, ANVISA and/or other regulatory inspections. **Knowledge, Skills, Abilities:** Must be an expert Quality compliance auditor. Experience with elements… more
- Boehringer Ingelheim (Duluth, GA)
- …strategic and operational initiatives to achieve USA priorities for RA and USA CMC objectives. This role is directly responsible for improving current processes and ... or to improve collaboration. The stakeholders will vary from USA GI Region, USA CMC , Corporate Affairs or regulatory agencies. + In partnership with RA project team… more
- Gilead Sciences, Inc. (Foster City, CA)
- …35 countries worldwide, with headquarters in Foster City, California. ** Senior Director,** **Product Management** **Team** **Lead** **(Early Phase)** **_Location: ... within the broader Pharmaceutical Development and Manufacturing (PDM) organization, the ** Senior Director, Product Management Team Lead** will lead a team of… more
- AbbVie (North Chicago, IL)
- …and execution of device and combination product industrialization programs. The program manager is to provide strategic oversight for one or more industrialization ... execution strategies with clearly defined deliverables and milestones. The program manager is to kick-off project/transfer teams, remove barriers to success, realize… more