- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the ... supervision. Acts as point of contact to cross-functional teams on US/EU RA CMC project issues.Execution of Strategy and Submissions: Develops strategy with… more
- Merck & Co. (Rahway, NJ)
- …the operational/executional arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS ... Areas, Portfolio Management, Process Optimization, Project Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance,… more
- Merck & Co. (Rahway, NJ)
- …arms within the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic and operational plans ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- Xaira Therapeutics (Brisbane, CA)
- …the Role We are seeking a highly skilled and proactive Associate Director, Research Project Manager to oversee the planning and execution of biologics projects ... Key Responsibilities Program Leadership, Planning & Execution Serve as the primary project manager for biologics R&D initiatives, ensuring day-to-day execution… more
- BridgeBio Pharma (San Francisco, CA)
- …focused on Transthyretin Amyloid Cardiomyopathy (ATTR-CM). What You'll Do The Sr. Manager , Quality Systems Management will report to the Vice President of Quality, ... CMC tasked with a wide range of responsibilities that...quality management systems (QMS) to ensure compliance with GxP regulatory standards and company policies. This position will also… more
- AbbVie (Waltham, MA)
- …Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls ( CMC ) works with ... department. Participates in initiatives internal to RA CMC . Represents CMC regulatory affairs on project initiatives with other functional areas to… more
- BeOne Medicines (San Mateo, CA)
- …taken when recalls or product complaints arise during product lifecycle for the assigned project . + Provide CMC regulatory review for clinical protocols and ... regulatory strategies as well as authoring CTD CMC sections for the assigned project to...is a plus. + Demonstrated leadership as a people manager . + Experience in authoring complex technical documents, CTD… more
- Sanofi Group (Morristown, NJ)
- …in eCTD format. + Ensure all CMC documentation is accurate, aligned with project objectives, and compliant with regulatory guidelines. + Serve as CMC ... **Job Title:** Manager , CMC Development and Dossiers **Location**...with technical project support, manufacturing, quality, or CMC dossiers for regulatory submissions (eg, Module… more
- Lilly (Lebanon, IN)
- …a successful startup into GMP manufacturing operations. **Position Description:** The CMC Project Management Professional is responsible for overseeing the ... Chemistry, Manufacturing, and Controls ( CMC ) activities for our pharmaceutical products. This role requires...from portfolio entry to global submissions/approvals and launch. The Project Manager is expected to have commercial… more
- Otsuka America Pharmaceutical Inc. (Bismarck, ND)
- …of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units ... associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external...needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,… more
- Merck (West Point, PA)
- …and the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS ... Areas, Portfolio Management, Process Optimization, Project Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance,… more
- Merck (Rahway, NJ)
- …arms within the business. Working independently, the Protocol Clinical Supplies Project Manager (Protocol CSPM) designs strategic and operational plans ... process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients… more
- University of Colorado (Aurora, CO)
- **Biomanufacturing Project Manager III** **Description** **University of Colorado Anschutz Medical Campus** **Department: Gates Institute Biomanufacturing ... Facility** **Job Title:** **Biomanufacturing Project Manager III** **Position #:** **00837358 -...basis. + 4 years of professional level experience in project management in a closely related regulatory … more
- BeOne Medicines (Emeryville, CA)
- …cost-effective production & continuity of supply + Partner with internal stakeholders such as CMC , Regulatory , Quality to ensure on time commercial launch & new ... **_General Description:_** Sr. Manager /Associate Director, Supply Chain CMO Management & PM...a scientific field. Minimum 10 years' experience within biopharmaceutical/pharmaceutical CMC development, GMP and regulatory requirements **Computer… more
- ThermoFisher Scientific (Wilmington, NC)
- …+ Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing ... of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. +… more
- AbbVie (North Chicago, IL)
- …Chemistry, Process Engineering, Drug Product Development (DPD), and Quality Assurance (QA) and CMC - Regulatory . Responsibilities: + Manager a small team (3 ... R&D) is a global analytical scientific organization responsible for all CMC analytical activities related to the development of AbbVie's pharmaceutical products.… more
- Haleon (Richmond, VA)
- …uniquely ours. Care to join us. It isn't a question. The **QA Manager ** leads Quality and Compliance activities for assigned product projects during the development ... as provide local support to the Richmond R&D site. + Engage cross-functional matrix project teams as key point of contact for quality aspects related to development,… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Development, Device Development and Clinical Package Engineering, Quality Assurance, Regulatory , Outsourced Manufacturing and Project Management partners to ... the care of patients with life-threatening diseases. The **Sr. Clinical Supply Manager ** is a leader that inspires teams while providing expertise for Gilead's… more
- Takeda Pharmaceuticals (Lexington, MA)
- …progress; manage individual study budgets and communicates status to appropriate TA project manager ; and execute communication and change management plans. + ... in leading cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory , CMC or other drug development related function. Clinical… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …real-world evidence, and creating hope for all facing illness. The Senior Manager , Supply Chain leads, develops, establishes, and manages the supply chain activities ... working with MTP internal colleagues in various functions (Quality Assurance, Regulatory Affairs, Marketing, Market Access, Medical Affairs, Drug Safety, Finance,… more
