The IT Compliance Manager will oversee Enterprise IT controls, processes, and transactions to ensure all relevant regulatory, legal, and internal compliance guidelines are followed What You'll Work On Develop the IT General Controls Framework, implement and manage an effective IT controls audit and compliance program for the enterprise across all domains of IT, and manage

/JOB PURPOSE Manages all regulatory activities for new development programs, pre IND through BLA/NDA and post approval. Responsible for developing and implementing global regulatory strategies encompassing clinical, non clinical and CMC disciplines. Provides expertise in translating regulatory requirements into practical, workable plans. Essential Duties And Responsibiliti

The Inventory Control Coordinator I's responsibilities are to maintain accuracy and control, with minimal supervision, of material receipts, raw material and finished goods inventory locations. We are hiring for the day shift. The work hours are Monday through Friday from 6am 2 30pm. What You'll Work On Maintain accurate logs and files for IQC receipts, lot control, and d

/JOB PURPOSE This role is responsible for supporting Exelixis' small molecule development from early stage development through commercialization. This role is part of a team that leads the efforts at our contract manufacturing organizations (CMOs) to direct all aspects of our Drug Substance (DS) development and manufacturing. Specifically, s/he guides our CMO partners in p

Under minimal supervision, the IT Full stack Developer will design and develop applications, working with business users to understand and compile requirements. The IT Full stack Developer will have primary responsibility for maintaining applications for various business departments. What You'll Work On Build and maintain a React based client for web and mobile based appl

/JOB PURPOSE The incumbent will be responsible for the day to day activities directed to support development and manufacturing of biological (antibody drug conjgates, mAbs, bispecifics) drug products (DP). The activities include formulation development, DP manufacturing process development, DP process technical ransfer, activities to support preparation and administration

The Equipment Technician III is responsible for the setup and maintenance of Penumbra's manufacturing and test equipment as well as the necessary documentation in accordance with Penumbra's Quality System. In addition, the Equipment Maintenance Technician III is responsible for training new equipment technicians. Specific Duties and Responsibilities Manage and perform mai

Exelixis is dedicated to building a world class Structural Biology group to accelerate the discovery and development of novel therapeutics to fight cancer. We are seeking a highly skilled and motivated electron microscopist to supervise the installation and operation of a G4 CFEG Titan Krios electron microscope. The successful candidate will have extensive experience in c

Under close supervision, the Employee Development Intern T will work on process improvement projects, assist with analyzing workshop data, and provide general support to the Employee Development team. The person in this position must be detail oriented, able to follow through and drive projects to completion, and able to effectively manage multiple tasks simultaneously. W

The Senior Scientist II works in a fast paced environment with the Formulation development team, part of PSC department to drive a science based approach in formulation development and strategy for small molecule projects from First in Human (FIH) formulations to commercial formulation development. The Sr. Scientist II will actively engage with key stakeholders from Proce

/JOB PURPOSE The PVRM Medical Director is responsible for the medical review of Individual Case Safety Reports (ICSRs) for Exelixis products and is involved with other safety deliverables (eg safety surveillance) for assigned project(s). The role collaborates closely with Drug Safety Operations staff (on medical aspects of ICSRs) and Clinical Development (medical ICSR disc

The Customer Order Specialist III is responsible for processing hospital purchase orders received from the US and Canada regions, ensuring timely and accurate order fulfillment, primarily responsible for resolving order and shipment discrepancies, and answering customer inquiries in a timely manner. What You'll Work On Ensure timely responses to general inquiries received

/JOB PURPOSE Responsible for managing and maintaining existing investigational new drug (IND) and clinical trial application (CTA) submissions and preparing amendments in compliance with guidelines and regulations. Coordinates, compiles, and tracks product applications to regulatory agencies. Essential Duties And Responsibilities Review clinical site regulatory documents t

The Customer Order Specialist II is responsible for processing hospital purchase orders received from the US and Canada regions, ensuring timely and accurate order fulfillment, and answering customer inquiries in a timely manner. We are open to hiring remotely within the US. Candidates in the Bay Area will be expected to be on a hybrid schedule, with 3 on site days per we

/JOB PURPOSE Ensures risk management, issue management, and risk/issue monitoring are implemented and embedded across their responsible trial portfolio and functional areas of focus. Ensures clinical research activities are conducted by clinical staff in accordance with ICH GCP, relevant international and local regulations, requirements, and guidelines. Partners with quali