- Catalent (Emeryville, CA)
- …developed a proprietary approach for site-specific bioconjugation to produce next- generation antibody- drug conjugates (ADCs). This technology, termed SMARTag®, ... purification, and HPLC (high-performance liquid chromatography) analysis of site-specific antibody- drug conjugates (ADCs). The Research Associate II reports to the… 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 ... obtaining approval to shipAssists in the creation of SOP's and work instructions specific to CSO Supply Planning as requested.Responsible for updating relevant Trial Master Files (TMF) with CSO-related documentsSupports the CSO Project Mgmt Lead in executing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Excellence and Innovation May lead and/or participate in Global Evidence Generation initiatives to improve the harmonization and efficiency of processes and/or ... 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)
- …with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted ... to ensure high quality data. Work closely with internal statistical programmer. Drug Development Strategy: Provides input to multiple aspects of the development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …reporting of clinical trials. preferred- Having knowledge of all phases of drug development, including early and late phase clinical development and submission ... preferred- Having solid background of applied statistics preferred- Solid knowledge of new advanced statistical methods using SAS preferred- Knowledge in database structures and set-up preferred- The candidate should have successfully provided programming… 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 ... will be expected to represent PDMB on cross-functional protein therapeutic teams through generation and interpretation of PK and PK/PD data as well as through… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …will provide for a differentiated, clear and sustainable platform of evidence generation , design and leadership of clinical development plans, and addressing all ... regulatory, drug and patient safety, data, CMC, IP, patient selection,...acumen.Providing best practices to DS's overall development strategy and drug development goals. Influencing their adoption and facilitating cross-functional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …& RWE 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 ... submissions- Assess RWE data gaps and building cross-functional evidence generation strategy for payers and reimbursement submissions- Build global cost… more
- Merck & Co. (Rahway, NJ)
- …company's Device Development (DD) Team designs, develops, and commercializes novel biologic/ drug /vaccine - device enabled combination products to achieve safe and ... strategy for multiple vaccine development programs ranging from concept generation /selection through commercialization and launch readiness:Lead the Device Development… more
- Merck & Co. (Rahway, NJ)
- …development for pipeline biologics, we innovate and build next generation biomanufacturing technologies. Examples include investments for development of continuous ... to the development of innovative and disruptive technologies for next- generation biologic manufacturing processesDevelop and characterize robust clinical processes… more
- Catalent (PA)
- …MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology ... and timeline of proposals for both new and ongoing drug substance programs and ensure scopes are adequately reviewed...Operations, clients, and key site stakeholders on the timely generation of and pricing for proposals, change orders, and… 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)
- …plus emerging pipeline assets) and key functions.- Contribute to data generation proposals and decision-making that optimizes Daiichi Sankyo's presence in GU ... disease strategy and the strategic choices for clinical development and data generation - Develop and define DAST best practices, including the development and use… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with IRT systems and support in managing the forecasting and planning of drug supply needs. Can participate effectively on a cross functional and on Global ... compromise patient dosing or safety. Supports comparator sourcing requirements, RFP generation and working with outsourcing to submit appropriate requirements on a… more
- Merck & Co. (San Diego, CA)
- …and characterization. -The role is a key interface with Immunology and other drug discovery and development scientists and functions within across our company as ... CHO and other methods as needed.Lead a small team that supports drug discovery programs through design, engineering, and characterization of biologics, including… more
- Merck & Co. (Rahway, NJ)
- …by integrating planning capabilities, data science / engineering, and insight generation into our Research & Development governance, planning, and monitoring ... Qualifications Bachelors degree required.Minimum of 4 years of experience in drug development within a pharmaceutical and/or a biotech company and/or professional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …overall program safety reporting (eg, Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety-related documents, in ... relevant DSI stakeholders on the disease area, competitive landscape, and compound/ drug . May serve as speaker for program/ franchise medical/scientific training in… more
- Merck & Co. (Rahway, NJ)
- …be responsible for all aspects of engineering including; planning, scope generation , process & facility design, equipment selection, vendor interaction, skid design, ... as the Technical Lead/Process Engineer with prior experience supporting complex Drug Substance Projects. Minimum 15 years of experience with engineering design,… more
- Taiho Oncology (TX)
- …as defined in the pharmacovigilance SOPs related to medical inquiries and drug safety information. Use medical affairs plans to develop and align the ... personnel. In collaboration with Medical Affairs personnel support data generation Investigator-Initiated Trials (IITs) and HCP initiated projects. Facilitate the… more
