- Merck & Co. (Rahway, NJ)
- …Description: Seeking a full-time Business System Associate for the Labeling Operations area within the GRACS Regulatory Innovation & Information Management ... Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Labeling, Regulatory Operations , Regulatory Submissions, Strategic Thinking,… more
- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionGRACS CMC - Associate Principal Scientist, CMC, R4 - Pharm Pre-approval Reporting to the Sr Director/Director/Principal Scientist/Sr Principal ... Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance… more
- Insmed Incorporated (San Diego, CA)
- …program lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to ... for Millennials™, and Best Medium Workplaces™ lists.OverviewLead Analytical Development Operations function to build out the process development support testing… more
- Eisai, Inc (Exton, PA)
- …Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of Biologics Operations maintains knowledge of established ... your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and...for Biologics Pilot Plant campaigns. Support providing data for regulatory documents as required.7. Ensure adherence of operations… more
- Merck & Co. (Durham, NC)
- …contact for all dealings between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a ... excellence in Compliance, Supply, Continuous Improvement, and Cost Management.--The Associate Director, External Manufacturing Operations will also assist… more
- Aequor (West Greenwich, RI)
- …1. Perform sample collection and sample handling to support GMP operations and Environmental/Water monitoring. 2. Perform testing and possible data review ... At all times, comply with safety guidelines, cGMPs/CFRs and other applicable regulatory requirements. Shift: Saturday - Tuesday shift schedule. Skills: Previous lab… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Warehouse Operations Associate III as part of the Technical Operations team ... individual will serve as a subject matter expert for warehouse operations and perform daily warehouse operation processes, including inbound, outbound, storage,… 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...daily production schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager, and Manager.Oversee the hiring, development,… more
- Merck & Co. (Rahway, NJ)
- …Experience with sterile GMP facility startup.Knowledge of Investigational drug regulatory requirements.Understanding of Clinical Supply Chain Operations .Current ... in Rahway, New Jersey.The Sterile Process Engineer role at the Associate Director level will leverage the individual's leadership, technical, and communication… more
- Merck & Co. (Rahway, NJ)
- …DescriptionAs a Technical Lead, you will report into Director, Chemical Technical Operations , External Manufacturing API Technology, and play a pivotal role in ... matters.Review process change requests and deviation reports while ensuring regulatory compliance.Education and Minimum Requirements:Bachelor's degree in engineering, chemistry… more
- Merck & Co. (Durham, NC)
- …questionnaire, blood test, chest x-ray Position Responsibilities:This role reports to an Operations Associate Director and supports the product transfer for a ... Management Process, Operational Excellence, Process Optimization, Process Troubleshooting, Production Operations , Production Support, Project Management, Regulatory Compliance,… more
- Merck & Co. (Rahway, NJ)
- …as a lead GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines ,- strategies ... practices related to clinical supply planning and incorporate them into the team's operations . - Focus on Customers & Patients. - Make rapid, disciplined decisions.… more
- Merck & Co. (North Wales, PA)
- …with partners, vendors, and vendor management team . Review and provide clinical operations input into relevant clinical documents such as the protocol and other ... engagements. This includes the ability to:--Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH) Proven ability to manage competing… more
- Aequor (North Creek, WA)
- …(Required): Position Summary: We are seeking an experienced, highly motivated Research Associate to join our Manufacturing Science and Technology (MSAT) lab team in ... The ideal candidate will have experience in common mammalian upstream unit operations , either in a development/MSAT lab or in manufacturing operations .… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for the ... including global independent medical education and symposia.Work with strategic planning & operations to manage the Global MSL projects budget by forecasting &… more
- Twist BioScience (South San Francisco, CA)
- The QC Associate II will be responsible for the implementation and continuous improvement of QC methods in the production laboratory. He/she will work closely with ... the operations team to monitor the quality of Twist DNA...stored, and distributed are manufactured in compliance with all Regulatory , Customer, and Twist requirements. In this position you… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams.Responsibilities: Study Strategy:… 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
- Aequor (Thousand Oaks, CA)
- …and reduce hand offs. Collaborate with cross-functional teams (clinical operations , site management, biostatistics, stats programming, TA) to optimize trial ... and ensure smooth integration into new and/or modified processes Regulatory Compliance and Quality Assurance: Ensure all data management...OR Bachelor's degree and 6 years of experience OR Associate 's degree and 10 years of experience OR High… more
- Aequor (Hicksville, OH)
- …breaks.Job Purpose Able to perform various inspecting, labelling and packaging operations . Tends machines that perform one or more packaging functions, such ... to all applicable procedures, cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.). Ensures all work… more
