- Novo Nordisk Inc. (Boulder, CO)
- …highly experienced and dynamic professional to manage parenteral drug product manufacturing , and corresponding CMC regulatory activities. The Manager of ... Manufacturing is accountable for clinical phase 1 and 2 drug product manufacturing and will have thorough knowledge of cGMP's for aseptic pharmaceutical… more
- Aequor (Northborough, MA)
- …Northborough Operations Center facility, is responsible for labeling and packaging of final drug product vials as finished product for sale and distribution to US, ... Quality Assurance, Materials Management, Facilities Engineering, Validation, Metrology and Manufacturing Technical Support groups. In addition, Packaging interacts 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 & ... of our company. - Position Description/Summary: - The GPAM Associate Director, Project Manager , is a core member of Early Drug Development and/or Late… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …furnished in written, oral, or diagram.Ability to deal with complexity across the drug product, the associated manufacturing process, and the end-to-end supply ... multiple myeloma.Legend Biotech is seeking QA Batch Disposition Associate Manager as part of the Quality team based in...wide range of activities to support the release of drug products for human use. This position is responsible… more
- Aequor (Thousand Oaks, CA)
- …supply chain within their components. end to end supply chain The Manager , Supply Chain (Demonstration Devices) manages contract manufacturing organizations ... experience preferred if the focus is on API, or Formulation and Drug Product manufacturing experience if the focus is on Drug Product manufacturing… more
- Merck & Co. (Rahway, NJ)
- …the Development Sciences and Clinical Supply (DSCS) organization, the Digital Program Manager will advance the purpose and aspiration of our Company 's DSCS ... organizational deliverables.- In this role, the DSCS Digital Program Manager will provide strategic and tactical direction and partner...Experience in one or more of the areas of Drug Substance development, Drug Product development, Clinical… 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...oversee cell therapy production and ensure safe and compliant manufacturing operations according to cGMP requirements. This individual will… more
- Tris Pharma (Monmouth Junction, NJ)
- …are followed in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) standards ... or skills needed and/or licenses or certificates preferredCertified Quality Manager , Engineer or AuditorExperience with drug -device combination products… more
- Merck & Co. (North Wales, PA)
- …team, the-Associate Director, US Oncology Marketing - Customer Engagement Manager -will work with marketing stakeholders, analytics professionals and- external media ... in an environment where they are interacting with multiple channels to access drug , medical and practice management information as needed, real-time. To enhance our… more
- Aequor (Thousand Oaks, CA)
- …progresses 's manufacturing network strategy to meet business goals; Finished Drug Product (FDP) and Integrated Supply Strategy, partners with the FDP ... and external risks that can lead to business disruption; Drug Substance (DS) and Drug Product (DP)...manufacturing network, quality, engineering, external supply and global logistics… more
- Aequor (West Greenwich, RI)
- …of Manufacturing activities. This position requires working directly with Manufacturing staff during bulk drug substance operations to facilitate real-time ... (2) working days the following week Notes from Hiring Manager Intake: What location will this role be tied...environment for this role? IE office based, lab based, manufacturing floor? This is plant quality assurance role, therefore… more
- Merck & Co. (North Wales, PA)
- …compounds or marketed products throughout the entire life cycle of the drug .Provides leadership as head of the Global Regulatory Team, which coordinates ... prepares our company teams for meetings with FDA at all phases of drug development.Leads cross-functional efforts to prepare for advisory committees and may speak at… 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, ... fills, and autoinjector assembly. This team produces clinical and development drug product batches in a GMP piloting facility supporting our research… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- The SQE Manager , QA Compliance, is responsible for managing the Supplier Quality Program at Exela ensuring timely completion of associated activities and ensuring ... of pharmaceutical production in compliance with all CFR, USP, cGMPs, and SOPs. SQE Manager , QA Compliance will rely on experience and judgment to plan and accomplish… more
- Merck & Co. (Rahway, NJ)
- …the Medical Writer on clinical/scientific and regulatory documents. Partners with Study Manager on study deliverables.Participates in the set up and design during ... and presentation skills.Education/ExperienceBachelor's Degree +9 years of pharmaceutical, clinical drug development, project management, and/or medical field experienceOR Master's… more
- Merck & Co. (North Wales, PA)
- …study materials (eg, ICF documents / amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design supports data collection in alignment ... skills Education/Experience Bachelor's Degree +5 years of pharmaceutical, clinical drug development, project management, and/or medical field experienceOR Master's… 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 ... divisions and functional areas; ensure integration with the Key Account Manager , Nurse Educator, Field Reimbursement Associate, Medicare Account Executive, and other… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the CAR-T Equipment team in support of on-going clinical and commercial manufacturing as well as facility expansions and improvements.Key Responsibilities As an ... 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
- Amgen (Thousand Oaks, CA)
- …Join us and transform the lives of patients while transforming your career. Senior Manager Manufacturing Systems ( Drug Substance Automation) **What you will ... Let's change the world. In this role, the Senior Manager is responsible for providing technical and administrative leadership...the main point of contact for automation function for Drug Substance Supply manufacturing . + Define, drive,… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- We are currently looking to fill a Manager External Manufacturing ( Drug Product Fill Finish) position. This position strategically leads business ... Operations & Product Supply (IOPS) product supply chains. The role of the Manager External Manufacturing ( Drug Product Fill Finish) is to act as the… more
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