- Novo Nordisk Inc. (Boulder, CO)
- … drug product manufacturing, and corresponding CMC regulatory activities. The Manager of Drug Product Manufacturing is accountable for clinical phase ... 1 and 2 drug product manufacturing and will have thorough knowledge of cGMP's for aseptic pharmaceutical products. Frequent cross functional interaction with… more
- Merck & Co. (Rahway, NJ)
- Job Description Job Description: - The drug development Project Manager is part of Global Project and Alliance Management (GPAM) which sits in the Research & ... - Position Description/Summary: - The GPAM Associate Director, Project Manager , is a core member of Early Drug...in project management or a related role required - Product development experience required ; in a pharmaceutical/biotech industry… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …policies, procedures, and all applicable regulations.Key Responsibilities Manage the team responsible for drug product batch record review and drug ... multiple myeloma.Legend Biotech is seeking QA Batch Disposition Associate Manager as part of the Quality team based in...oral, or diagram.Ability to deal with complexity across the drug product , the associated manufacturing process, and… more
- Merck & Co. (Rahway, NJ)
- …in solving complex problems. Experience in one or more of the areas of Drug Substance development, Drug Product development, Clinical Supply management or ... Sciences and Clinical Supply (DSCS) organization, the Digital Program Manager will advance the purpose and aspiration of our...is desirable. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product , Analytical… more
- Aequor (Thousand Oaks, CA)
- …and API manufacturing experience preferred if the focus is on API, or Formulation and Drug Product manufacturing experience if the focus is on Drug ... chain within their components. end to end supply chain The Manager , Supply Chain (Demonstration Devices) manages contract manufacturing organizations (CMOs) that… more
- Tris Pharma (Monmouth Junction, NJ)
- …or skills needed and/or licenses or certificates preferredCertified Quality Manager , Engineer or AuditorExperience with drug -device combination products ... in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems… more
- Genmab (Plainsboro, NJ)
- …to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager /Associate Director will be responsible for leading the development and ... Safety Information (CSI), United States Package Inserts (USPI), Summary of Product Characteristics (SmPC), and their associated Patient Labeling Documents.Serve as… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Operations Manager as part of the Technical Operations team based in Raritan, NJ. ... Role OverviewThe CAR-T Operations Manager is an exempt level position working within Technical...within the facility to ensure high quality and compliant product supply and oversee production metrics. This individual will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted ... team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical programmer.… more
- Aequor (Thousand Oaks, CA)
- …Intelligence (BR&I), identifies internal and external risks that can lead to business disruption; Drug Substance (DS) and Drug Product (DP) Network Strategy, ... 's manufacturing network strategy to meet business goals; Finished Drug Product (FDP) and Integrated Supply Strategy,...a highly motivated individual for the Strategic Resource Planning Manager role. You will be an integral member of… more
- Merck & Co. (North Wales, PA)
- …Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Develops worldwide product regulatory strategy to optimize label and obtain shortest time to ... by regulatory agencies for multiple indications simultaneously.Provides expert advice to Product Development Teams and subsidiaries on regulatory issues as they… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to ... in other areas as needed. Relationships Reports to a Manager , Senior Manager , Associate Director or Director....Annual Reports & Annual ADE Reports, IND Safety Reports, Drug & Establishment Listings, responses to FDA communications, among… more
- Aequor (Northborough, MA)
- …the Northborough Operations Center facility, is responsible for labeling and packaging of final drug product vials as finished product for sale and ... procedures and both written and verbal instructions from the supervisor/ Manager . Perform manual packaging on an assembly line. Ability...up to 35 lbs. and move heavy objects (eg, product vial cages, pallets of packaging materials). Ability to… more
- Merck & Co. (Rahway, NJ)
- …(FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and clinical manufacturing facility in Rahway, ... suspension/bottle fills, and autoinjector assembly. This team produces clinical and development drug product batches in a GMP piloting facility supporting our… more
- Genmab (Plainsboro, NJ)
- …for this location.Another focus of the role is the active support of product -oriented development (POD) teams in the security of processes related to (web) ... Genmab IT&Digital (IT&D) department is moving towards a value-driven and product -oriented department, the security leader will work closely with several POD… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Drug Development Strategy: Provides input ... with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted… more
- Merck & Co. (Minneapolis, MN)
- …in a complex buying environment. This includes the multiple channels of drug distribution, Oncology GPO's, wholesalers and specialty pharmacies. Review and evaluate ... other customers meet their needs. Influence beyond their specific geography or product area demonstrate advanced ability to ask strategic, insightful questions to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …relevant cross functional groups to enable robust production, testing and release of product to patients. This individual will be an integral part of the CAR-T ... of this analysis can be conveyed to the Maintenance Manager in a structured way so that he can...status, uniformed service member or veteran status, or any other characteristic protected by law.Legend Biotech maintains a drug -free… more
- Wolters Kluwer (Indianapolis, IN)
- …of the **Wolters Kluwer Health Clinical Effectiveness team** , the Lead **Technology Product Manager ** **- Commercial Drug Information** role for ... continuous improvement activities **Other Duties** + Be a driver for product innovation in US drug pricing benchmark data types including WAC, AWP, NADAC, ACA… more
- Wolters Kluwer (Madison, WI)
- …invite you to join our dynamic team of awesome designers, clinicians, engineers, and product managers who all share the same passion as you! Your role for Medi-Span ... specifically and also impact our customers across the globe. **RESPONSIBILITIES** + Product delivery and execution for new products, features and offerings following… more
