- Twist BioScience (South San Francisco, CA)
- The Regulatory Operations Specialist is responsible for ensuring the efficient and compliant management of regulatory documentation, with a primary focus on ... combination of education and work-related experience. Minimally 2 years of experience Regulatory Operations within a biotechnology, life sciences, or chemical… more
- Merck & Co. (Rahway, NJ)
- …Policy Implementation, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Labeling, Regulatory Operations , Regulatory Submissions, ... Required experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement… more
- Merck & Co. (Rahway, NJ)
- …integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations , Non-clinical, Clinical, and other functional areasExperience ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Merck & Co. (Upper Gwynedd, PA)
- …Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance ... assigned development products. -Primary responsibilities include, but are not limited to: Regulatory Responsibilities: Serve as a CMC Product Lead for assigned… more
- Eisai, Inc (Nutley, NJ)
- …role ensures studies are conducted efficiently, within budget, and in compliance with regulatory standards. The Head of Clinical Operations leads teams of study ... operations components. Key Responsibilities:Manage and oversee the clinical operations function, ensuring compliance with GCP and regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory ... Process Excellence & Analytics function, responsible for ensuring Daiichi Sankyo's Regulatory processes & procedural documentation are fit for purpose and compliant… more
- Merck & Co. (Rahway, NJ)
- …critical role in driving member satisfaction, improving efficiencies, and ensuring regulatory compliance while advancing the credit union's payments strategy in ... with overall business goals and member needs.Monitor industry trends, emerging technologies, and regulatory changes to keep the credit union on the cutting edge of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan, ... NJ. Role OverviewThe Director of Operations is an exempt level position...controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor various… more
- Merck & Co. (Durham, NC)
- …Process, Operational Excellence, Process Optimization, Process Troubleshooting, Production Operations , Production Support, Project Management, Regulatory ... your career.We have an exciting opportunity for a Specialist to join the operations team supporting a capital project critical to Human Health at our facilities… more
- Merck & Co. (North Wales, PA)
- …engagements. This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing ... DayValid Driving License:NoHazardous Material(s):NoRequired Skills:Adaptability, Adaptability, Clinical Data, Clinical Operations , Clinical Outcomes, Clinical Research, Clinical Study Design, Clinical… more
- Insmed Incorporated (San Diego, CA)
- …for Millennials™, and Best Medium Workplaces™ lists.OverviewLead Analytical Development Operations function to build out the process development support testing ... lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to take care… more
- Merck & Co. (Millsboro, DE)
- …, Manufacturing Quality Control, Media Preparation, Process Improvements, Regulatory Compliance, Safety Practices, Science, Standard Operating Procedure (SOP) ... Job DescriptionOur Manufacturing Operations teams are the people that make our...cycle-Assist with equipment setup and operation.-Performs manual and/or automated operations , general maintenance and support functionsHousekeeping in all work… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Warehouse Operations Associate III as part of the Technical Operations team based ... individual will serve as a subject matter expert for warehouse operations and perform daily warehouse operation processes, including inbound, outbound, storage,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position Support the operations and execution of affordability programs across the Diabetes, Obesity and Rare Disease ... Market Access, Legal, and Compliance to establish and monitor the program operations and related forecasts for affordability programs. Works with key internal… more
- Eisai, Inc (Exton, PA)
- …and close-out reports for Biologics Pilot Plant campaigns. Support providing data for regulatory documents as required.7. Ensure adherence of operations to cGMP, ... profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading and building a scientific team… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …individuals in other NNI departments, including but not limited to Medical, Regulatory , Marketing, Sales, Commercial Operations , and Ethics, Compliance & ... Privacy. May interact with government agencies, law firms, trade organizations and other external agencies. Reports to a Managing Assistant General Counsel. Essential Functions In collaboration with other attorneys, serves as a legal advisor for assigned… more
- Merck & Co. (Durham, NC)
- …is seeking a dynamic and versatile leader for External Manufacturing Operations , Drug Delivery Systems and Devices within our Manufacturing Division (Associate ... Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a strong business partnership and ensuring… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …knowledge in process development, technology transfer, process comparability, CMC regulatory guidelines, process monitoring and manufacturing operations ... Biotech is seeking a Global Process Steward as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position is a senior technical… more
- Aequor (Thousand Oaks, CA)
- …will need to demonstrate knowledge of DP technical process, manufacturing operations , scientific method, basic regulatory compliance expectations, and ... in Trackwise, ensuring records are comprehensive and compliant per GMP regulatory procedures. This must occur through a Right-First-Time approach. Proactively… more
- Merck & Co. (Durham, NC)
- …equipment validation, process validation, and GMP laboratory readiness.- The Quality Operations Laboratory Specialist performs laboratory testing on a variety of ... and techniques as they relate to laboratory testing start-up, regulatory requirements for new assay development/validation, project timelines and budgeting.Build… more
