- 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
- 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …and supply our critical medicines and vaccines around the world.External Manufacturing Operations Associate Director (Ops AD), in partnership with the respective ... eight (8) years combined experiences in commercial/business and manufacturing ( operations , project management, or quality, technology, supply chain etc.) function… 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
- 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
- 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
- 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
- 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)
- …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
- Aequor (Thousand Oaks, CA)
- …site and to directly support both manufacturing and Quality Control operations . Under minimal supervision analyze environmental monitoring samples, cross check ... align with safety guidelines from EHSS, cGMPs, and other applicable regulatory requirements. Adhere to good documentation practices. Complete all required training… 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
- 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
- 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)
- …safety programs.Stay current with industry trends, emerging technologies, and regulatory changes impacting HVAC operations in pharmaceutical environments.Prepare ... Job DescriptionAssociate Director HVAC : The HVAC Associate Director is responsible for leading and developing...for leading and developing a team that supports HVAC operations and system infrastructure at the Rahway (RY) NJ… 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 (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
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