- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …management activities across the study duration.- Operational Excellence and Innovation May lead and/or participate in Global Evidence Generation initiatives to ... Qualifications- At least 5 years of experience as statistician supporting drug development and/or post marketing in Clinical research, Pharmaceutical company, CRO… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in meeting or teleconferences with Health AuthoritiesGlobal strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately ... with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted… more
- Catalent (PA)
- Proposal Lead I Summary Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to ... MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology… more
- Merck & Co. (Rahway, NJ)
- …strategy for multiple vaccine development programs ranging from concept generation /selection through commercialization and launch readiness: Lead the Device ... with respect to device component manufacture and final assembly of biologic/ drug product with device constituent part. Lead /support the development,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to global Development governance. In this key role, the candidate will have to lead a complex, global team in charge of a global clinical program designed to ... representative of asset through the lifecycle from research to post-marketing functions. Lead all GPT meetings, ensure team and cross functional alignment, positive… more
- Merck & Co. (Rahway, NJ)
- …by integrating planning capabilities, data science / engineering, and insight generation into our Research & Development governance, planning, and monitoring ... & Development division.The Associate Director, PMO People & Process Lead , is a unique role that will be heavily...Bachelors degree required.Minimum of 4 years of experience in drug development within a pharmaceutical and/or a biotech company… more
- Merck & Co. (Rahway, NJ)
- …overseeing the management of process utility system associated with a large drug substance pilot plant including WFI generation /distribution, Process Chillers, ... a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned… more
- Catalent (St. Petersburg, FL)
- Supplier Quality Regional Lead Position Summary: Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the ... of the Global Supplier Quality Management team, the Supplier Quality Regional Lead will be responsible for management and leading the Supplier auditors performing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …are in-process. Supports investigational product distribution activities at the vendor, including generation of drug orders, review of shipping documentation and ... Trial Master Files (TMF) with CSO-related documentsSupports the CSO Project Mgmt Lead in executing additional operational and logistical duties as discussed and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Oncology will lead the HEOR and RWE implementation and evidence generation for a successful market access strategy across Daiichi-Sankyo. He/She will drive the ... development plans, and commercialization plans and other critical documents.Responsibilities- Lead the preparation of global value dossiers which present the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and people with disabilities.Summary Reporting to the Disease Area Strategy Team (DAST) Lead for GU Cancer, this position is integral to R&D and partners with ... the DAST Lead to build and execute a disease area strategy...emerging pipeline assets) and key functions.- Contribute to data generation proposals and decision-making that optimizes Daiichi Sankyo's presence… more
- Merck & Co. (Boston, MA)
- …Associate Principal Scientist to contribute to our company's protein therapeutic drug discovery and early clinical development efforts. -This position will be ... research labs in Boston, MA.- The ideal candidate will lead PDMB efforts as a project-team representative and PK/PD...to represent PDMB on cross-functional protein therapeutic teams through generation and interpretation of PK and PK/PD data as… more
- Merck & Co. (San Diego, CA)
- …in mammalian cell lines including transient HEK, CHO and other methods as needed. Lead a small team that supports drug discovery programs through design, ... and characterization. -The role is a key interface with Immunology and other drug discovery and development scientists and functions within across our company as… more
- Catalent (St. Petersburg, FL)
- …supplier integrity and oversight. The Quality Auditor will be p erforming audits, generation of audit reports and management of supplier CAPA to ensure required ... requesting sites risk assessment to ensure alignment to Global Standards Ensure generation of audit reports, management of supplier response and CAPA. Work… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …needed- Clinical Development Expertise Strategy- In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of the ... overall program safety reporting (eg, Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety-related documents, in… more
- Merck & Co. (Rahway, NJ)
- …Required Experience and Skills: This position will function as the Technical Lead /Process Engineer with prior experience supporting complex Drug Substance ... Maintenance, Automation, Plant Operations and Safety), Engineering Firms and Vendors to lead projects and progress deliverables. - The Director would be responsible… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …experience. required and - Prior work experience as a project manager, project lead , or similar role within pharmaceutical drug development desirable. preferred ... related assignments may include project management, process improvement, tool generation (checklist, process map, etc.), change management and detailed analyses.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …meeting or teleconferences with health authorities Operational Excellence Innovation - May lead and/ or participate in global evidence generation initiatives to ... experience in data science / business intelligence / statistics role supporting drug development and/or post marketing in clinical research, pharmaceutical, CRO or… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. It's not your average production site - it's a ... Performs regular internal audits of NNUSBPI facilities as a lead auditor Works closely with Manufacturing and Quality Control...years of direct QA experience Experience in a licensed drug or biologic facility regulated by the FDA, EMEA… more
- Black & Veatch (Orlando, FL)
- ** Lead Electrical Engineer - Conventional Power Generation - Florida Atlantic Coast (Hybrid)** Date: Jun 21, 2024 Location: Coral Gables, FL, US Coral Gables, ... project lead experience and expertise inutility scale conventional power generation project design + Previous engineering consulting design experience in LV/MV… more
