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/JOB PURPOSE The Sourcing Specialist will work closely key partners within the Strategic Sourcing and Procurement (SS&P) department. This individual will support the Category Lead and partner with Category Managers in their assigned category(ies) to performs activities related to purchasing of materials, equipment, and/or services. This individual will collaborate with bus
Posted Today
/JOB PURPOSE The Senior Facilities Lab Specialist role is responsible for performing periodic preventative maintenance and repairs activities on lab utilities, process and lab equipment and systems and is the first in house responder for service calls for the equipment. This role requires accurate recording of data and completion of work order paperwork in support of facil
Posted Today
/JOB PURPOSE The Associate Corporate Counsel, Contracts will provide transactional legal support to the Pharmaceutical Operations & Supply Chain client group (PSC), and other departments within the Research & Development division, in collaboration with cross functional business teams and with support from senior members of the Legal team. Please note this is an onsite role
Posted Today
/JOB PURPOSE The Senior Compliance QA Director for Inspections is accountable for providing the strategy and direction and is responsible for leading and managing the Inspection Readiness program for GxP regulated areas, including systems managed by external vendors. This role ensures company wide departmental inspection readiness via interaction with stakeholders, develop
Posted 1 day ago
Reporting to the Vice President, GI Marketing, the Sr Director, GI Marketing will lead the development of the GI strategic plan, and line extension launch planning for possible new GI products and/or indications. ESSENTIAL DUTIES AND RESPONSIBILITIES Lead the cross functional effort required to generate and refresh the GI 3 year and annual strategic brand plans Establish
Posted 1 day ago
Exelixis
- King of Prussia, PA / Alameda, CA
/JOB PURPOSE The Associate Clinical Supplies Director designs, develops, and implements the clinical supplies strategy to ensure appropriate processes are established and clinical supplies deliverables are met for clinical trials. This individual also manages clinical supply activities including planning and forecasting of clinical supply, oversight of clinical packaging,
Posted 1 day ago
/JOB PURPOSE The Associate Director, Product Management Cybersecurity Operations & Engineering designs, implements, manages, and improves secure technology solutions for the organization's information systems. The position is responsible for analyzing the organization's current cybersecurity infrastructure and identifying any weaknesses or vulnerabilities that must be addr
Posted 1 day ago
Exelixis
- Alameda, CA / King of Prussia, PA
/JOB PURPOSE Manages all regulatory activities for new development programs, pre IND through BLA/NDA and post approval, with a particular focus on biologics (ADCs, bispecifics, and etc.). Responsible for developing and implementing global regulatory strategies encompassing clinical, non clinical and CMC disciplines, as well as companion diagnostics, as appropriate. Provide
Posted 1 day ago
/JOB PURPOSE The Strategic Supplier Relationships Director is responsible for optimizing partnerships within multiple areas; including (but not limited too) full service CRO providers, central and local laboratories, interactive response technology, pharmacovigilance and data management service providers. This individual is the key point of contact for Product Development
Posted 1 day ago
Exelixis
- Alameda, CA / King of Prussia, PA
/JOB PURPOSE Provides leadership to the biostatistics function and direct management of biostatistics staff in developing statistical strategy, design, and analyses for clinical trials for multiple compounds with a focus on early phase (1/2) trials. Sets direction for statistical support of translational medicine and clinical biomarkers. Understands at a deep level clinica
Posted 2 days ago
Exelixis
- King of Prussia, PA / Alameda, CA
/JOB PURPOSE The Associate Regulatory Operations Director is responsible for overseeing submission activity for the company's submission portfolio, with first line accountability for managing the submission forecast and ensuring proper staffing for upcoming submissions. She/he utilizes in depth knowledge of global regulatory submission requirements and works collaborativel
Posted 3 days ago
Exelixis
- Alameda, CA / King of Prussia, PA
/JOB PURPOSE Responsible for primary regulatory review of promotional materials and scientific exchange communications. This role demonstrates proficiency in understanding and interpreting Federal regulations and guidances and company standard operating procedures (SOPs) to support the advertising and promotions of Exelixis' FDA (Food and Drug Administration) approved prod
Posted 3 days ago
Exelixis
- Alameda, CA / King of Prussia, PA
/JOB PURPOSE This role is responsible for overseeing all aspects of drug safety study operational activities from study start up to close out. This individual oversees case workload distribution, responds to case questions, coordinates multiple drug safety projects and/or studies simultaneously, involving interaction with business partners, CRO's, and specialty pharmacies
Posted 3 days ago
/JOB PURPOSE The Sr Manager provides technical leadership and support across multiple CMC biologics areas to drive downstream process development, technology transfer, and manufacturing of biological drug candidates with a focus on therapeutic proteins' purification process development. The Sr Manager utilizes their technical expertise in downstream/purification process de
Posted 7 days ago
/JOB PURPOSE The Scientist IV, Biologics Upstream Process Development will independently conduct laboratory experiments with limited supervision to develop cell culture processes and support technology transfer and manufacturing of biological drug candidates. The incumbent will utilize their technical expertise in upstream/cell culture process development of biologics (the
Posted 7 days ago
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