- Merck & Co. (Rahway, NJ)
- …to the leader of Packaging and Combination Product Commercialization, the Director of Sterile Product Packaging Development is responsible and accountable for ... sterile development portfolio, and delivering on organizational unit priorities.-- The Director will be responsible for new product packaging development for vaccine… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Monitor and track the breakdown of the Quality Manual into an annual Quality Plan, including quality risk assessments and inspection readiness components ... Affairs programs. This role involves deputizing for the Sr. Director , representing the Quality organization at senior...with Medical Affairs to facilitate the implementation of a risk -based quality management process fully embedded through… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Summary: The Director , Combination Product Commercialization is a key leadership role within the Device Development and Technology Organization. ... with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead a team of engineers and technical staff to support global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Job Summary: Director , Global QA Strategy &Operations (Global R&D PV QA) is responsible for ... team, developing standard approaches that foster a reputation for outstanding quality , collaboration, rigor, and follow-through. Collaborate with the Head Global RD… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Summary: -The Associate Director of Device Technology is a key leadership role within the Device Development and Technology Organization. This ... on autoinjectors, prefilled syringes, and other drug delivery systems. The associate director will be a technical subject matter expert on the device components… more
- Insmed Incorporated (San Diego, CA)
- …Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director of ... regulations and guidelines.ResponsibilitiesResponsibilities (Essential Role Responsibilities):Establish and maintain a risk -based and scientific-based quality system to support… more
- Merck & Co. (Durham, NC)
- …is seeking a highly motivated individual for the role of Assoc. Director , Engineering.- This role will provide end-to-end support of manufacturing science and ... products including Drug Substance, Drug Product, and Analytics.-We are seeking an Assoc. Director to join our Live Virus Vaccine (LVV) team. The successful candidate… more
- Merck & Co. (Rahway, NJ)
- …all platforms (eg syringes, auto injectors, bottles, blisters) meet safety, efficacy, quality , and robust supply standards. Drive proactive risk management ... Job DescriptionDir, Engineering - Director , Assembly and Packaging Platform Technical LeadershipReporting into the Executive Director Packaging Technical… more
- Repligen (Waltham, MA)
- OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham, MA facility which has proven experience in the biotechnology ... in Waltham, MA and will report to the Sr. Director , Quality - Quality Network...external audit schedules; serve as host for site auditsMaintain risk -based strategy for overall Quality compliance across… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily ... best practices, foster a culture of continuous improvement in benefit- risk evaluation, and participate in inspection readiness activities.Responsibilities:This individual… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting into the Executive Director Packaging Technical Operations the Director Packaging Distribution, Components and Systems Center of ... of commercialized products for the benefit of patients. The Director of Packaging Distribution, Components and Systems COE is...view and solve problems to achieve results Drive proactive risk management activities, including risk assessment, … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …internal and external (especially regulatory, but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned ... centered around rare diseases and immune disorders. Job Summary: The Sr. Director , Clinical Safety MD, will lead the development and implementation of integrated… more
- Merck & Co. (Rahway, NJ)
- …Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and Systems COE the Director ... products for the benefit of patients. The Logistics and Distribution Technology Director is integral to this mission. The successful candidate will possess deep… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting into the Director , Logistics and Distribution Technology the Associate Director , Logistics and Distribution Technology will be ... products for the benefit of patients. The Logistics and Distribution Technology Director is integral to this mission. The successful candidate will possess deep… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Senior Director of Clinical Operations will manage clinical operations staff to ensure ... ongoing collaboration and communication with internal stakeholders. Detailing The Senior Director will ensure a robust communication plan including status and timing… more
- Merck & Co. (Rahway, NJ)
- …administrative processes.Support the development of GMP Documentation such as:- Risk Assessments, Batch Records, Sampling Plans, Qualification Documents, and ... single-use environment, and bioprocessing equipmentStrong working knowledge of cGMP, Quality Systems (problem, deviations, change management, etc.), Safety for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Executive Director , Data Management (Head of Global Data Management) sets the vision, ... development of group members and also monitors trends in functional performance via quality , time, and cost indicators, and develops plans and leads the execution… more
- Merck & Co. (North Wales, PA)
- …supply of commercialized products for the benefit of patients. The Associate Director of Equipment Engineering is integral to this mission. The successful candidate ... project close-out.Thorough knowledge and proven expertise in GMP application and quality systems, particularly in process and equipment qualification & validation,… more
- Insmed Incorporated (San Diego, CA)
- …Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director , Regulatory Affairs will serve as the regulatory leader on ... regulatory representative on cross functional teamsCommunicating regulatory strategies and risk assessments to cross-functional teams and senior leadership, as… more
- Merck & Co. (Rahway, NJ)
- …pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research ... and downstream processes that produce high yields along with superior product quality and allow speedy progression for clinical studies and commercial launch. The… more
