- Merck (Rahway, NJ)
- …and increased integration of CMC and Clinical strategies. **Position Description/Summary:** The Senior Specialist, Project Manager , is a core member of ... that improve human health and business. Under GPAM, the CMC Integrated Project Management (CIPM) organization was...efforts to progress the Research & Development pipeline. The Senior Specialist is expected to provide project … more
- Gilead Sciences, Inc. (Foster City, CA)
- …countries worldwide, with headquarters in Foster City, California **About the role:** The CMC Regulatory Affairs Sr. Manager at Gilead is responsible for ... providing strategic direction, operational support, and technical expertise for CMC regulatory activities and related regulatory initiatives. **Responsibilities:** +… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the ... point of contact to cross-functional teams on US/EU RA CMC project issues. + **Execution of Strategy...Leads US FDA/EU EMA interactions with support from higher-level manager . + **Regulatory Knowledge:** Demonstrates expert knowledge of US/EU… more
- Merck (Rahway, NJ)
- …Controls ( CMC ) and Clinical strategies. **Position Description/Summary:** The Associate Director, Project Manager , is a core member of DCTs, partnering with ... improve human health and business. Under GPAM, the Chemistry Manufacturing & Controls ( CMC ) Integrated Project Management organization was formed to enhance our … more
- BeiGene (San Mateo, CA)
- **General Description:** + The Manager , Regulatory Affairs CMC , is responsible for developing and implementing global regulatory CMC strategies to secure and ... Functions of the Job:** + Serve as the regulatory CMC representative on project teams. Provides ...organization. **Significant Contacts** + Interacts with BeiGene employees and senior management. + Interacts with external business partners and… more
- Astellas Pharma (Westborough, MA)
- **Regulatory Manager , Regulatory Affairs - CMC (Gene Therapy)** Do you want to be part of an inclusive team that works to develop innovative therapies for ... work are encouraged to apply. **Purpose and Scope:** Responsible for developing regulatory CMC strategy for assigned projects. Identifies and collects CMC data… more
- Frontier Medicines (South San Francisco, CA)
- Join Frontier Medicines on an exciting journey as our newest Senior Manager /Associate Director in CMC Development, located at either our Boston or South San ... of our team, reporting directly to the Head of CMC , you'll play an integral role in advancing our...cultivating vendor relationships + Supervising third-party activities and delivering project updates with recommendations Traits we believe make a… more
- Integra LifeSciences (Plainsboro, NJ)
- …implementing procedures, and remediation projects. The candidate must be a senior -level professional/team player with advanced knowledge and experience who thrives ... Microbiology, and Sterility Assurance department and working with the ** CMC Plainsboro, NJ** Integra manufacturing site. Qualified candidates must possess… more
- Takeda Pharmaceuticals (Boston, MA)
- … CMC team AD representative or team lead). + Represent functional area on CMC project teams by communicating activities from designated functional area to ... or externally. + Identify and plan broader technical objectives ( project and scientific related) with input from manager...Ability to design and direct analytical strategy to meet CMC project objectives. + Experience in preparing… more
- GE Aerospace (Evendale, OH)
- …your opportunity to thrive in a cross-functional, dynamic environment. **Job Description** The Senior CMC Laboratory Operations Manager is responsible for ... for a lab focused on cutting-edge ceramic matrix composite ( CMC ) technology. In this critical role, you will be...of 5 years of experience in a program or project leadership role within an engineering environment. **Desired Characteristics**… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** ** Senior Manager : Strategic Sourcing and Supplier Management, Devices** Gilead ... with headquarters in Foster City, California. **KEY RESPONSIBILITIES:** The Senior Manager , Strategic Sourcing & Supplier Management,...issues of high complexity. + Communicates issues to line manager and project teams in a timely… more
- Schrodinger (Cambridge, MA)
- We are looking to hire a ** Senior Manager /Associate Director of Clinical Pharmacology** to join us in our mission to discover and develop drugs that improve ... stakeholders including DMPK, translational medicine, clinical development, clinical operations, regulatory, CMC , and project management to ensure completion of… more
- Novo Nordisk (Lexington, MA)
- …lives for a living. Are you ready to make a difference? The Position The Senior Director can be accountable for the Clinical pharmacology strategy for phase 1-4 in ... and administration strategy, including dose setting and dosing regimen for project (s), Scientific and pharmacology aspects of trials in the clinical development… more
- City of West Sacramento (West Sacramento, CA)
- …Plans Examiner I3.00% Plans Examiner II5.35% Program Technician I2.07% Program Technician II0.21% Project Manager II2.91% Senior Accountant4.64% Senior ... Plans Examiner II/ Senior - Community Development Print (https://www.governmentjobs.com/careers/westsacramento/jobs/newprint/4206726) Apply Plans Examiner II/… more
- CSL Behring (King Of Prussia, PA)
- …the biotechnology or pharmaceutical industry** **At least 4 years as a project manager leading and managing complex, cross-functional drug development ... progress over time, and identify areas for further improvement.** **Engage with senior leadership, project sponsors, and other stakeholders to communicate the… more
- West Pharmaceutical Services (Exton, PA)
- …and current state-of-art standards/regulations. + Collaborate with regulatory lead(s), cross-functional project manager (s) and SMEs (Subject Matter Experts) in ... environment and planet through our sustainability efforts. **Job Summary:** This Senior Specialist, Regulatory Project Management (RPM) role is responsible… more
- Vera Therapeutics (Brisbane, CA)
- Title: Senior Director, Commercial Supply Chain Management Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company ... suffering from immunological diseases. Position Summary: We are looking for a Senior Director, Commercial Supply Chain Management, to lead and manage end-to-end… more
- Gilead Sciences, Inc. (Foster City, CA)
- …our team, **Biologics Pre-Pivotal Formulation and Process Development,** as a ** Senior ** **Research Associate I.** Once onboarded, the successful candidate will ... working environment, and continuous improvement + Help support key project or department stakeholders as needed to ensure that...as well as identity and report inconsistent results to manager or supervisor + Participate in group meetings and… more
- Ascendis Pharma (Palo Alto, CA)
- …for strategic and operational regulatory input and support for cross functional ( CMC , non-clinical and clinical) collaboration with other project team members. ... all aspects of the business, from drug development to marketing. The Manager , Regulatory Affairs will be responsible for supporting and developing global regulatory… more
- Rush University Medical Center (Chicago, IL)
- …input to his/her supervisor to identify areas of opportunity within the manager 's scope, escalate risk and resolve barriers. This position will provide direction, ... in accordance with Rush policies and procedures. **Responsibilities:** * Appropriately manage project billing by ensuring costs are correctly billed and invoices are… more
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