- Novo Nordisk Inc. (Boulder, CO)
- …research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. Our R&D hub merges ... worlds to develop new medicines for patients. The Position The Technical Team Lead , API Manufacturing works in Novo Nordisk's Boulder, Colorado Pilot Plants and is… more
- Aequor (Thousand Oaks, CA)
- …to ensure quality reports. Produce medically accurate ICSRs reports Act as MSRT product lead and/or therapeutic area lead Execute ICSR case escalation to GSO as ... tool Monitor the compliance of autolabel tool updates (if applicable) Support and lead Quality Assurance of ICSR medical review (if applicable) Support and lead… more
- Repligen (Clifton Park, NY)
- OverviewThe Extrusion Lead will report to the Extrusion SupervisorResponsibilitiesOperation of a mill to combine starting raw materialsOperation of extruders and ... dimensional measurements using precision instrumentsResponsible for following SOPs and safety proceduresResponsible for area cleanliness and inspection readinessAbility to… more
- Merck & Co. (Rahway, NJ)
- …and continuously enhance performance. Maintain a strong focus on compliance and Environmental Health and Safety (EHS) to drive supply excellence. Serve as the ... Compliance Reviews, Data Analysis, Decision Making, Drug Product Manufacturing, Environment Health and Safety , Global Mindset, Interpersonal Relationships, Lean… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Study Report (CSR). May review tables, listings, and figures (TLF) and CSR safety narrativesMay lead the development and updates of the Investigator's Brochure ... assessment of protocol deviationsDiscusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of adverse… more
- Merck & Co. (North Wales, PA)
- …on product safety and efficacy, and when required, interact with Health Care Provider to help answer unsolicited medical information requests. The Medical ... all medical information resources and standard response documents containing product safety , tolerability and efficacy data. Interact with Health Care… more
- Merck & Co. (Rahway, NJ)
- …across many diverse areas including Biological, Chemical, Automation, Safety , Technical Services, Process Development, Analytical, Regulatory, and Quality.As ... and sustain technical standardization of best practices across the network. Lead assignment execution against accelerated timelines, in a right-first-time manner,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Specialty Medicine portfolios, in alignment with the business strategy Lead the DSG inspection management activities by ensuring continued submission, compliance ... with regulatory and company strategy. Act as management representative for all key health authority inspections (US FDA, EU EMA, MHRA etc.,). Develop and maintain an… more
- Merck & Co. (Rahway, NJ)
- …Research & Manufacturing, in a fast-paced, multidisciplinary environmentParticipate in or lead 1) development of robust and scalable upstream processes for biologics ... expertise; guide career development; build strong, collaborative teamsChampion compliance and safety ; promote a culture of diversity, inclusion, and equity MINIMUM… more
- Merck & Co. (Rahway, NJ)
- …on assistance for daily production activities while ensuring compliance with Safety & Environmental (S&E) and current Good Manufacturing Practices (cGMPs) ... PR&D pipeline. Responsibilities: - Under the scientific direction of a facility lead , the Operations Specialist will participate in equipment setups, raw material… more
- Merck & Co. (Rahway, NJ)
- …and technical leader with expertise in cell culture development & commercialization to lead a team of approximately 3-5 scientists, who lead multidisciplinary ... successful PPQs and BLAs for the company's pipeline.Champion compliance and safety ; promote a culture of diversity, inclusion, and equity.Minimum Education… more
- Merck & Co. (Rahway, NJ)
- …and status updates to project sponsors and management.Champion compliance and safety ; promote a culture of diversity, inclusion, and equity.Minimum Education ... of US/EU regulatory requirements and analytical methods required to ensure viral safety and characterization of cell banks, and expert knowledge of cGMP principles… more
- Repligen (Hopkinton, IA)
- …Protective Equipment) and adhere to chemical hygieneFollow all safety protocolsDemonstrate Repligen's R-TEAM ValuesWhat Repligen OffersExcellent Benefits! Health ... Manufacturing Operator 2nd Shift reports to the Manufacturing Line Lead and helps in performing all tasks involved in...play a key role in ensuring that the department's safety , quality, and production goals are met.2nd Shift (3pm… more
- Merck & Co. (Rahway, NJ)
- …submissions and associated documentation. Provide expertise as the Global Regulatory Lead to Product Development Teams and the regulatory single point-of-contact for ... products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Key functions:Reports to Senior Principal Scientist (Senior Director)… more
- Merck & Co. (Boston, MA)
- …to discover and develop innovative medicines that change the course of human health . In the RaDS value team, the Product organization is responsible for implementing ... RaDS Product organization. The position will report to the Lead of the Disease Biology and PharmTox Product Line....tools. Work with external vendors of genomics, molecular biology, safety and target discovery tools and data to assess… more
- Merck & Co. (Rahway, NJ)
- …challenges across projects and functional teams, in a fast-paced, multidisciplinary environment. Lead the development of robust and scalable upstream processes for ... guide career development; build strong, collaborative teams.Champion compliance and safety while promoting a culture of diversity, equity, and inclusion.Minimum… more
- Eisai, Inc (Raleigh, NC)
- …healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking ... to meet the demand forecast. The Director, Western SCM Unit will lead a cross-functional team driving excellence in Import/Export Compliance, Logistics, and Supply… more
- Eisai, Inc (Nutley, NJ)
- …healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking ... operations, including ongoing review of literature and compilation and interpretation of safety data to support product strategies. May plan and prepare report… more
- Repligen (Clifton Park, NY)
- OverviewThe Packaging Operator will report to the Packaging Lead . Responsibilitiesability to gown appropriately and operate in an ISO 7 environmentexecute assigned ... packaging floor tasks.responsible for following SOPs and safety proceduresresponsible for area cleanlinessread and understand quality and inspection… more
- Merck & Co. (South San Francisco, CA)
- …based Senior Scientist with experience in biochemical/biophysical assays and lead discovery support to join our Quantitative Biosciences (Pharmacology) department. ... binding assays to characterize biomolecular interactions (equilibrium and kinetic) for lead discovery and optimizationSupport a wide range of biochemical and… more
