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Assoc Dir, Clinical Trial Management Position Overview The Associate Director is responsible to lead and drive clinical operations for their assigned global clinical studies/programs and to ensure the global clinical studies/programs are executed to support the successful registration of new products/indications. They will manage resources, training and budgets for their GCTM teams. They will provide input to the operational strategy and into key documents for example study protocols and....


Associate Director, Process Development Position Summary: This position will support the development of novel active compounds within the company pipeline. Specifically, this position will provide strategic leadership for drug substance unit operations, scale-up and optimization in development from R&D to cGMP Phase 3 manufacture to process validation. Specific areas of focus include reaction engineering, crystallization and process modeling. The individual is expected to integrate QbD....


Associate Director, Biologics Development Position Overview The Associate Director, Up-stream , will be an instrumental team member of the Biologics Development Process Sciences Department, based in Irvine, CA. The primary roles of this position are to independently plan, design, and execute the experiments and develop processes to support protein expression, fermentation, and purification process development of natural and recombinant proteins (including neurotoxin and antibodies) from....


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....


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....


Two MD contractors needed for Global Pharmaceutical company in Cambridge, MA two roles-Contract Role Only One year contract (renewal up to 4 years), w-2 with benefits offered Has to be office based in Cambridge- we will only consider local candidates at this time. We need PV experience within submissions specifically We have a submission approaching for a product. Need someone with good clinical trial experience. Worked in clinical trial as opposed to post trial setting SPA or European....


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.....

- Any US State

Clinical Project Manager will support management of a Cardiovascular Stem Cell pivotal clinical trial in the US. The suitable candidate will work under minimum supervision and contribute technical and clinical operations expertise (including onsite and remote monitoring of clinical sites and core facilities). In addition, the candidate will assist in the training of perspective investigators in the pivotal clinical trial and support clinical cases. Travel is anticipated to be approximately....

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