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High Profile Pharmaceutical company with recent FDA one of a kind approval is hiring a Senior Manager of Regulatory Affairs CMC Reporting to the director technical writing of RA CMC of Regulatory Affairs, the Senior Manager of Regulatory Affairs, CMC will be responsible for the preparation of high quality regulatory submission content focusing on CMC to support global clinical development, registration, and product life cycle management in accordance to regulatory requirements and guidelines.....


Staff Electronic Hardware Engineer Hackettstown, NJ This role is with a global leader in medical technology (imaging, diagnostics, healthcare IT), an organization dedicated to ongoing success by hiring top talent, investing in R&D, and commitment to engineering excellence for over 100+ years. We currently have an opening for an experienced Electronic HW Engineer. The successful candidate has broad experience in electronics design and must be able to work in across functional and across


Sr. Scientist, Process Sciences Summary/Objective: The Senior Scientist plans and conducts experiments to increase the body of scientific knowledge on topics related to the scientific endeavors for our Client. Research may be carried out at a molecular level, using appropriate cell and animal models effects of various factors. Initiates, directs and executes all pre-clinical scientific research and/or development strategies in research and/or development. The senior scientist investigates the....


My client is a dedicated contract development and manufacturing organization (CDMO) focused on development and cGMP manufacturing of biopharmaceutical products derived from mammalian cell culture. They provide a comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. They have 25 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and....


SENIOR ENGINEER, DELTA V RECIPE LEAD JOB DESCRIPTION Seeking a team player that strives for best-in-class operations amongst a high-performing global team in our Pharmaceutical Operations & Technology IT organization. This lead engineer acts as recipe lead on a DeltaV/Syncade-driven fully integrated facility. This lead creates DeltaV and Syncade design and recipe standards for project that will be used as global standards. The role requires extensive experience and strong knowledge of....


The Senior Manager Clinical Operations is responsible for developing operational strategy for one or more clinical studies, and leading the cross functional Study Management Team to align and deliver on study goals of data quality, timelines, budget and GCP compliance in support of overall program level plans. Responsibilities: The Senior Manager Clinical Operations Lead will independently plan all aspects of the clinical operations for one or more clinical studies and oversee the execution of

- Waltham, MA

TOP TIER PHARMACEUTICAL COMPANY in MASSACHUSETTSglobal biopharmaceutical company developing innovative medicines The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates Position SummaryWe have the need for a highly collaborative, experienced Manager of Medical Writing Operations to join our team based in MA. The position reports into our Director of Medical Writing and will lead writing responsibility of documents which ensure....


We are actively seeking a Quality Assurance Validation Manager to join our growing team. The Quality Assurance Validation Manager is responsible for providing leadership and strategic direction to the establishment of the validation/qualification programs (including the Qualification/PM/Calibration of instruments, equipment, and facilities) and ensuring alignment with corporate standards and regulatory guidance. This position will be responsible for ensuring successful implementation of....

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