- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …application of QSP within Oncology/Immuno-Oncology. ResponsibilitiesDevelop and apply Quantitative Systems Pharmacology (QSP) models to address drug -discovery ... rare diseases and immune disorders. Summary The Associate Director, Quantitative Systems Pharmacology (QSP) will work within the Quantitative Clinical Pharmacology… more
- Tris Pharma (Monmouth Junction, NJ)
- …have an immediate opening in our Monmouth Junction, NJ facility for a Director, Drug Safety. The Director, Drug Safety is responsible for planning, directing, ... stakeholders to ensure high quality submissions are made to the Food and Drug Administration (FDA) to meet company goals. ESSENTIAL FUNCTIONS Assists and supports… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Quality Systems Lead role as part of the Quality Operations team based in Raritan, ... New Jersey. Role Overview The Quality Systems Lead role is an exempt level position with...2 years of leadership experience is preferred. GxP Quality System knowledge, including relevant regulations and guidances (eg 21… more
- Tris Pharma (Monmouth Junction, NJ)
- …Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management Systems (QMS) supports, oversees ... Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record specifications.The incumbent uses… more
- Merck & Co. (Rahway, NJ)
- …capital and non-capital improvement projects, and interfacing with the automation system assets spanning production, utility systems and associated ... (eg, isolators).Experience interacting with or overseeing the management of process utility system associated with a large drug substance pilot plant including… more
- Merck & Co. (Rahway, NJ)
- …execution of capital and non-capital improvement projects, and the automation system assets spanning production, utility systems and associated infrastructure.- ... a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned… more
- Novo Nordisk Inc. (Boulder, CO)
- …responsible for supporting other processes in the Novo Nordisk Quality Management System as well as driving continuous improvement projects within the department ... eg frequent interactions with NN vendors throughout the GMP drug substance and drug product manufacturing process...and leverages relationships with HQ SMEs, process management, and system management to influence process and system … more
- Merck & Co. (Rahway, NJ)
- …capital and non-capital improvement projects, and interfacing with the automation system assets spanning production, utility systems and associated ... room facilities.Experience interacting with or overseeing the management of process utility system associated with a large drug substance pilot plant including… more
- Catalent (St. Petersburg, FL)
- …and systems issues, defining requirements, and recommending enhancements for system features and related processes.Assist in development of site related data ... capsules per year. The featured RP Scherer softgel technology is a proven oral drug delivery solution to enhance bioavailability of poorly soluble Rx and OTC drug… more
- Insmed Incorporated (Bridgewater, NJ)
- …associated with method development, qualification/validation, transfer and characterization for drug substance, drug product and reference standards. The ... and maintenance. The Manager will also serve as business owner for all computerized systems and will serve an active role in CSV activities including, but not… more
- Merck & Co. (Durham, NC)
- …with technology transfer or startup methodologies for introduction/launch of a cGMP drug substance Experience with electronic systems :- SAP, ProCal, DeltaV and ... responsible for providing cycle development and PQ for equipment and systems supporting bulk biological processes (ie Sterile Supply, Adjuvant Manufacturing,… more
- Aequor (Thousand Oaks, CA)
- …decisions concerning distribution complaints. Sales Order Management: - Create and manage Clinical Drug Shipments in an ERP system - Generate customs invoices - ... requirements, partner with key stakeholders to manage shipments of clinical drug product to clinical sites, globally. Key Responsibilities and Activities General:… more
- Merck & Co. (Rahway, NJ)
- …the development/commercialization space and an associated standardization of the digital systems and associated support services that enable the execution of these ... launch of a new generation of products, including antibody drug conjugates and peptides, will blur the boundaries between...an ideal opportunity for thinking differently about our overall system architecture and digital support models in line with… more
- Merck & Co. (Rahway, NJ)
- …a deep understanding of how our clients navigate business processes and enabling systems to deliver their job responsibilities. In this role, the candidate will ... improvements to our infrastructure (eg knowledge management, training, and enabling systems ) and drive initiatives on that roadmap that improve processes and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and the systems that support these processes (eg the transparency system ). This role also is responsible for operationalizing systems and processes ... requirements for transfers of value, price reporting, disclosure requirements, sharp/ drug takebacks), Representative and Organizational licensure (eg, OR rep… more
- BioAgilytix (Durham, NC)
- …fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You'll gain experience with a variety ... responsible for overseeing the programming and implementation of automation laboratory systems . This role requires a deep understanding of laboratory automation… more
- Merck & Co. (Rahway, NJ)
- …facility which is responsible for interfacing with scientists who are manufacturing drug substance to support early clinical studies, scaling up new chemistries, and ... is building a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) drug substance lab and the Specialist will become a subject matter… more
- BioAgilytix (Boston, MA)
- …Watson LIMS or automation; liaise with all parties to promote adoption of systems for increased efficiency Creates and manages system Standard Operating ... fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You'll gain experience with a variety… more
- Merck & Co. (Rahway, NJ)
- …companies); and 3) Ensuring that essential elements of the quality management system are in place for studies conducted in partnership with non-commercial ... by key authorities such as the USA Food and Drug Administration, European Medicines Agency, UK Medicines and Healthcare...of CQO, maintain and QC the global inspection tracking system that tracks all GCP Regulatory Health Authority inspections,… more
- Catalent (Philadelphia, PA)
- …and guidance world-wide, including but not limited to, good manufacturing practice/quality system requirements of the Food and Drug Administration, state boards ... System Validation documentation review and approval for instruments, equipment, and systems used in GXP Operations throughout the system life cycle. Other… more
