- Aequor (Thousand Oaks, CA)
- …education to expanding current job responsibilities. is searching for a Sr. Project Manager in our CMC Integration team within Operation Products Advancement in ... on our main corporate campus in Thousand Oaks, CA. The Sr. Project Manager (PM) will be responsible for integrating Process Development (PD) activities by developing… more
- AbbVie (South San Francisco, CA)
- …8, Masters with 6, or PhD with 3 years of CMC biologics functional experience. + Senior Manager : Bachelors with 10, Masters with 8, or PhD with 5 years of ... that are compliant with global regulatory requirements. Partners with CMC teams during the development of CMC ...with CMC teams during the development of CMC control strategies. Implement well-defined, efficient processes for preparation… more
- BeOne Medicines (San Mateo, CA)
- …be responsible for development of strategies, planning, drafting, and managing CMC -related regulatory submissions and HA interactions to meet the aggressive ... projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. **Essential… more
- 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
- 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
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …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
- Option Care Health (Riverside, CA)
- …aspects of patient registration responsibilities within the Customer Management Center ( CMC ). The Manager , Patient Registration manages the overall performance ... and/or time spent) + Directly oversees the patient registration activities with the CMC to ensure all performance expectations for time to yes, quality and cash… more
- BeOne Medicines (Emeryville, CA)
- …**:** The Manager , Regulatory Compliance Programs reports to the Senior Director of Regulatory Compliance and is responsible for driving program-level compliance ... guidance across Regulatory Operations, Regulatory Affairs, Quality, Safety/Pharmacovigilance, Clinical, CMC , and Regulatory Technology teams. While Regulatory Operations manages… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …variances and concerns as well as identity and report inconsistent results to manager or supervisor + Participate in group meetings and efforts by presenting data ... or related scientific fields with 2+ years of industrial experience in biologics CMC development + Hands on experience working with biologic products is strongly… more
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