- Daiichi Sankyo, Inc. (Bernards, NJ)
- …BLA Supplements (PAS, CBE-0, CBE-30), Annual reports, Lot Distribution Reports, Biological Product Deviation Reports, and Drug Listings. Ensures that CMC ... research areas centered around rare diseases and immune disorders.Summary The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Vice President (AVP) has primary responsibility for the planning and directing clinical research activities involving new or marketed ... drugs for oncology indications. The Associate Vice President will manage and oversee the entire cycle of clinical development, including study design, initiation,… more
- Merck & Co. (Rahway, NJ)
- …of our Research & Development Division is seeking applicants for an Associate Principal Scientist position available at its Kenilworth, New Jersey research ... facility.- The Associate Principal Scientist is a laboratory-based scientific role tasked...and lab informatics disciplines to enable development of Biologics drug substances and drug products.- The successful… more
- Merck & Co. (Rahway, NJ)
- …and large molecules from preclinical toxicology studies to commercialization. -Driving drug product design from the bench to manufacturing facilities, ... deep fundamental understanding and characterization including screening and designing drug product compositions, developing scalable processes, and defining… more
- Merck & Co. (North Wales, PA)
- …coordinates, and provides biostatistical leadership and support for related drug /vaccine projects in Late Development Statistics.Interacts with Clinical, Regulatory, ... trials, and in coordinating the statistical activities for clinical drug /vaccine projects. May interact with Contract Research Organization (CRO).This position… more
- Merck & Co. (Rahway, NJ)
- …Experimentation (FLEx) Center is a multi-modality (small molecule, biologics, vaccine) Drug Product development and clinical manufacturing facility in Rahway, ... the FLEx Center in Rahway is looking for an Associate Specialist - Process Engineer to lead clinical supply...electronic batch records and MES systems.Knowledge and experience of drug product processing.Desire and willingness to learn… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Ophthalmology will focus on driving strategy, development, and ... plans from the ground up. They will also be responsible for leading Product Development Teams and guiding Clinical Directors within their group to ensure that… more
- Aequor (Providence, RI)
- …management skills Understanding of biologic and synthetic pharmaceutical bulk and drug product manufacturing and analytical techniques General knowledge of ... this vital role, you will provide support to the Product Quality (PQ) organization as a subject matter expert...experience, OR Bachelor's degree & 5 years of Quality, Operations , Scientific, or Manufacturing experience OR Associate 's… more
- Merck & Co. (Rahway, NJ)
- …a motivated scientist with technical expertise in Biologics Potency assays in drug Development. More specifically, the ideal candidate will be a recognized expert ... assays for the development of therapeutic proteins, monoclonal antibodies, antibody- drug conjugates, and/or new modality-based products.--The successful candidate is… more
- Merck & Co. (North Wales, PA)
- …BARDS supports proactive assessment, transparent communication, and effective management of product risk profiles across our Research and Development Division pre- ... Management Safety Teams.- Lead and provide statistical support for related drug /vaccine projects in Clinical Safety StatisticsInteract with Safety Physicians, Safety… more
- Merck & Co. (Durham, NC)
- Job Description Associate Technician - - Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a ... is in direct support of our Downstream Purification manufacturing process for Bulk Drug Substance. Focused areas of responsibility include but are not limited to… more
- Insmed Incorporated (San Diego, CA)
- …data trending, process deviation resolution, process improvements and scientific expertise in the Drug Substance and Drug Product . Provides strong technical ... areas (Upstream cell culture, downstream processing, and buffer) as well as drug product .Experience leading and/or interacting with GMP manufacturing, process… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Biotech is seeking Global Commercial Program Head as part of the Technical Operations team based in Raritan, New Jersey. Role OverviewThis position is a key ... whose responsibility it is to deliver a best-in-class high volume marketed CAR-T product . This effort is business critical and part of a multi-site global… more
- Merck & Co. (North Wales, PA)
- …statistical programming activities for multiple and/or late stage drug /vaccine clinical development projects. -Accountability predominantly includes the development ... programming point of contact and knowledge holder through the entire product lifecycle. Primary Activities :Effective analysis and report programming development and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary: The Technician, Operations - Compounding will be responsible for assisting with the compounding activities of manufacturing solutions and ... sanitation, and documentation activities associated with the production of drug products. This position supports the ongoing development, manufacture, and… more
- Merck & Co. (Rahway, NJ)
- …laboratory to commercial scale, step across boundaries and implement novel innovations during drug product development to enable best science at first filing for ... work environment.Essential Knowledge, Duties & Responsibilities for the Director Include:Sterile drug product development concepts, tools, and requirements for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …from Global Safety Surveillance and other cross functional teams. Oversees daily operations of the function by directing staff and adhering to company-wide policies, ... Hub. Key internal stakeholders include Medical & Science, Clinical Operations , Regulatory Affairs, Data Management, Biostatistics, Non-clinical, Medical Affairs,… more
- Merck & Co. (Rahway, NJ)
- …functional impactProactively identify key biopharmaceutics risks at each stage of drug product development for small molecules and/or biologics, conducting ... team is responsible for the research and development of sterile & parenteral drug products for biologics as well as the biopharmaceutics support for the oral… more
- Merck & Co. (Rahway, NJ)
- …will be directly responsible for a team of approximately 10-15 senior and associate level scientists in Rahway, New Jersey. -The position is accountable for ... and Quality by Design principles, and advanced data analysis for drug development applications.- Requirements: Ph.D. in biochemistry, analytical chemistry, molecular… more
- Lilly (Indianapolis, IN)
- …improvement of products that are supplied to Lilly sites and the market. The Operations Associate is accountable to the Joint Process Team Leader. **Key ... Objectives/Deliverables:** To support on-going CM Operations by providing an oversight at the Joint Process...All key relevant functions at the contract manufacturers. + Drug product External manufacturing leadership. + Lilly… more
