- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one ... Functions Leads and manages the NAO Quality PV Oversight support function for NNI Patient Safety (PS) with 'Right First Time' mindset to effectively deliver… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPrincipal Scientist - Mixed Modalities, Sterile Product DevelopmentThe Mixed Modalities team within Sterile Product Development is responsible for ... such that the process is scalable without compromising stability, safety , efficacy, and delivery. -During development, we leverage smart experimental… more
- Merck & Co. (Rahway, NJ)
- …development skillsets.Demonstrated strength in delivering results on firm deadlines in support of product discovery, process development and commercial filings ... & tri-specific antibodies, and fusion proteins as well as the biopharmaceutic support for the oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the… more
- Aequor (Hicksville, OH)
- Packager - Support Specialist 2nd shift Packaging = /hr pay rate rd Shift Packaging = /hr pay rateImportant that they are able to work on the 1st shift (6:45 am - ... are operating the lines and handling the material/equipment according to product specifications, reviewing batch paperwork, performing line clearances, setting up… more
- Merck & Co. (Durham, NC)
- … transfer for a new facility in Durham, NC within Drug Substance, Drug Product and/or supporting areas. Support and execute to approach for production team as ... and develop remediation plans when applicableCollaborating across diverse teamsCreating strong safety cultureContributing to the manufacturing team and support … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one ... to business improvement projects. Interacts closely with Marketing & Patient Support Solutions and NNI Patient Safety . External relationships include… more
- Aequor (East Syracuse, NY)
- …and validation, specifications, reference standards, extended characterization, and product stability/ shelf-life. Support regulatory inspections, third-party ... of raw materials, excipients, in-process, drug substance, and drug product samples including HPLC/UPLC methods and various other analytical techniques… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one ... NNI Patient Safety and NNI processes to mitigate deviation occurrence Support internal and external stakeholders with issue resolutions in a timely fashion and… more
- Merck & Co. (Rahway, NJ)
- …with regulatory standards (eg, FDA, cGMP), maintain optimal environmental conditions for product quality, and support continuous operations. The ideal candidate ... staff members are adequately trained and practice safe operating procedures in support of requirements.Ensure compliance ( Safety , Health, Environmental, GxP (as… more
- Merck & Co. (Rahway, NJ)
- …supply disruptions.Collaborate with Research Laboratories groups during New Product Introductions/Technical Transfers and new technology.Offer on-site support ... Safety , Interpersonal Relationships, Lean Manufacturing, Manufacturing Processes, Manufacturing Support , Pharmaceutical Manufacturing, Regulatory Compliance, Root Cause Analysis (RCA),… more
- Merck & Co. (Durham, NC)
- …Safety Regulations, Quality Assurance, Risk Management, Deviation Management, Product Release, Change Control).- Supply Chain Management:-Manage coordination with ... to deliver Pharmaceutical, Biologic, and Vaccine Products. Our team works with a " Safety First, Quality Always" mindset.-As the primary point of contact for all… more
- Aequor (Hicksville, OH)
- …with numbers to accurately count components, waste and finished goods products. Support and implement safety initiatives, wearing all personal protective ... filling and packaging operations. Major Accountabilities Supplies production line with product and packaging components as required. Loads and unloads components or… more
- Tris Pharma (Monmouth Junction, NJ)
- …calibration of analytical instruments, carries out and documents laboratory work to support product development and analytical method development and supports ... believe in each other and in respectful, open and honest communications to help support individual and team success.Our AR&D lab is located in our Monmouth Junction,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThis Senior Engineer position will provide engineering support to the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center, primarily ... to the supply network and existing commercial products undergoing process optimization. Support is inclusive of both start-up operations (FLEx Sterile1) and new… more
- AUROBINDO (Durham, NC)
- …history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization has given Aurolife a jump start ... APUSA and submit the Pre-alert documents to broker to expedite receipt of incoming product through customs and the FDA. The position is also required to work closely… more
- Merck & Co. (Rahway, NJ)
- …Knowledge of Regulations/Industry Guidance (NFPA, ATEX, CE, And OSHA)Process And Product Safety TestingReviewing And Developing Safety and ... complex workstreams and implement capital project scope and technical studies that support business objectives, with focus on Process Design and Process Safety… more
- Aequor (Tampa, FL)
- …projects. Perform required testing on raw materials, intermediates and finished products. Support QC chemist to provide the method technology transfer and project ... Ensure the microbiological integrity of environment, equipment and facilities. Manages product testing based upon internal and customer specifications. Managing 3rd… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Local/Global Pharmacovigilance (PV) service providers responsible for Call Center, individual safety case processing, and aggregate reporting for DSI products, both ... and marketed. Maintains compliance with Global PV regulations for individual case safety and periodic reporting. Contribute as a key DSI contact for PV… more
- Taiho Oncology (FL)
- …Sr. Manager, Medical Field is non-promotional in nature. Responsibilities and Duties: Product /Therapeutic Area Support to External Stakeholders: Act as the ... a specified geography for information pertaining to disease state and Taiho's product (s) and compounds to ensure awareness and understanding. Provides high quality… more
- Aequor (Walkersville, MD)
- Support the finishing area including screening product components and kit assembly Preparation of packing materials and supplies for finishing activities ... procedures and instructions for all activities in which the team participates. Safety Responsibility Is knowledgeable and complies with all pertinent safety … more
