- Aequor (Davie, FL)
- …the considered for the role: Worker with construction / roofing experience. Project management for facilities in pharmaceutical company - preferably solid orals ... Basic qualification includes Master's engineering degree, project management experience and certification, 3&plus years of experience in the pharmaceutical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Commissioning and Qualification Project Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis ... and existing qualified systems within cell therapy manufacturing. The Commissioning and Qualification Project Manager will develop and manage all aspects of the… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …with company and or regulatory procedures, practices and guidelines Follow all safety & environmental requirements in performance of duties Other duties as assigned ... manufacturing quality system, including knowledge of FDA requirements preferred Strong project management capabilities to guide the creation of high-quality SOPs… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …projects. Interacts closely with Marketing & Patient Solutions and NNI Patient Safety . External relationships include interactions with NNI vendors involved in the ... of Contact for PV Deviation process covering NNI Patient Safety Acts in the role of Deviation Responsible for...audits and inspections Demonstrate leadership skills via acting as project lead on cross-functional projects in the development and/or… more
- Genmab (NJ)
- …Programming Manager will support the Data Management, Statistics, Drug Safety , Medical, Clinical Pharmacology and Biomarker functions with the above by ... we would love to have you join us!The Programming Manager supports the development of new therapies by ensuring...pooling of data across clinical trials within the same project .Supports in-house production of analysis datasets, tables, figures and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Employee Engagement Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewJoin our dynamic team at Legend ... New Jersey! We are looking for a dedicated and action-oriented Employee Engagement Manager to lead our engagement initiatives. In this newly created role, you will… more
- Aequor (Aliquippa, PA)
- …the 3PL. Primary objectives: Ensure current Good Manufacturing Practices (cGMP) and Safety compliance. Utilizes project management skills to support Logistic ... shipments and quantity discrepancies, including quality record ownership. Ongoing project management focused on continuous process improvement. Provide and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for the pivotal studies, Integrated Summary of Efficacy (ISE)/Integrated Summary of Safety (ISS) for oncology submission compounds, and expedite the preparation of ... and ensure its quality and integrity- Oversee statistical programming vendor on project planning and execution to ensure high quality deliverables and timelines met.… more
- Genmab (NJ)
- …work with other functions including Data Management, Statistics, Drug Safety , Medical, Clinical Pharmacology,Translational Research, Medical Writing, Project ... would love to have you join us!Overview: The Programming Manager supports the development of new therapies by ensuring...pooling of data across clinical trials within the same project . Supports submissions by ensuring that the programming package… more
- Merck & Co. (Durham, NC)
- …engineering design standards, guidelines and business plan; receives guidance from manager when necessary.Provides & Implements technical guidance to given tasks, ... for plant engineeringEnsures utility operations daily priorities and schedules project /work meeting the criteria established by site objectives.Support & lead… more
- Merck & Co. (Durham, NC)
- …shop floor leadership.- Key Responsibilities for a Drug Product Operations Manager Accountability - Project SupportFirst-line operations supervisor with a ... Job DescriptionThis role is within a capital project start-up in Durham, North Carolina. The new...the design and construction of the facility, the Operations Manager will play a critical role in supporting the… more
- Merck & Co. (Durham, NC)
- …several years; currently Durham employs 1,000+ people. This role as a Manager , Operations will be an energetic, leader with strong interpersonal, leadership, and ... with a team of individual contributor production direct reports including safety , quality, and daily operations;Ensure that Shift(s) objectives are achieved while… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …& the business through serving as a process champion for an assigned special project as needed Follow all safety & environmental requirements in the performance ... by conducting investigations and providing appropriate guidance to drive manager consistency and compliance in handling performance management Provide support… more
- Merck & Co. (Durham, NC)
- …as well as our Company policies and procedures.-Responsible for ensuring required safety guidelines are followed.-Review and approval of electronic batch records and ... processes or procedures.Review and approve automation interventions.Actively participates in project suite teams, as required.Other: Direct support of regulatory… more
- Merck & Co. (Durham, NC)
- …our Manufacturing Division (Associate Director).-This role serves as a Virtual Plant Manager - responsible for leading a cross-functional team in oversight of our ... Biologic, and Vaccine Products. Our team works with a " Safety First, Quality Always" mindset.-As the primary point of...years in direct management of shop floor production activities. Project Management - Proficient with Project Management… more
- Merck & Co. (Durham, NC)
- …Carolina facility is seeking to hire an experienced and technically proficient people manager to lead a team of Validation engineers. This leader will collaborate ... Validation partners and strategically balance the team structure to support project scope changes and priorities. Manage the proposals, budgeting, and forecasting… more
- Merck & Co. (Durham, NC)
- …troubleshooting and maintenance support for a new product feasibility project /manufacturing support. Develops standard operating procedures (SOP's) and preventative ... guided by policies, procedures and business plan; receives guidance from manager .Manage multiple priorities and advance several tasks in parallel.Must be flexible… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and other vendors to ensure high quality of ... advanced knowledge of medical terminology capture and reporting of safety data, pharmacovigilance, industry best practices, and relevant regulatory requirements.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technical and career, of direct reports, and mentors or acts as functional manager of skip-level or ex-US staff. This position requires strong knowledge about RBQM, ... regulatory requirements and ICH guidance. This position requires excellent project and people management skills, verbal/written skills, analytical, organizational,… more
- Eisai, Inc (Nutley, NJ)
- …Associate Director must be a highly specialized individual contributor or functional manager with advanced knowledge and expertise to analyze assess and initiate ... end user support to other areas of Data Operations, Data Management, Clinical Safety Data Review and Clinical team. The Assoc. Director of Clinical Programming will… more
