- Merck & Co. (Rahway, NJ)
- Job Description Job Description: The Rahway based Senior Specialist, Global Development Quality Operations - API, is responsible for independent review and approval ... and approve documentation accompanying the disposition of API materials (including new modalities such as ADCs) to ensure conformance to appropriate regulatory… more
- Genmab (Plainsboro, NJ)
- …an innovative and growing organization? At Genmab, we're seeking a Senior Director, Strategic Planning & Effectiveness to drive cross-functional communication, ... US market. This role will serve as Chief of Staff to the US, General Manager focusing on evolving...US, General Manager focusing on evolving operating models, building new capabilities, optimizing resources, and leading key US business… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with the 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 ... lives for a living. Are you ready to make a difference? The Position The Senior Director of CMR Knowledge & Technical Advancement (KTA) Department will serve to act… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for ... Leader to drive strategy development and create an integrated product development plan and timelines. Ensure execution of overall...proposals and stage gate proposals for formal presentation to senior management. Can step in, as needed, on behalf… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …the request for pricing (RFP) process.Direct and coach cross functional team staff in areas such as quality, compliance, safety, project planning, process ... design requirements, project timelines and milestones.Build and maintain a staff of professional, highly motivated and knowledgeable individuals. Participate in… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …monitoring the existing systems with respect to quality of final product and efficiency of operation. Responsibilities will include:Strong technical skills, be ... cost analysis, capital projects, change controls, and proposal for integrating new machinery-utilities into the site.This site operates 24/7, and you may… more
- BAXTER (Batesville, IN)
- …tooling and production equipment, weld processes, quality control standards, or product design, powder coating, materials and parts.Troubleshoot new or ... associates as needed.Provide shop floor support and develop welding processes for new products.Guide technical staff engaged in developing materials for specific… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Manager will be responsible for ensuring efficient production processes, managing staff , and optimizing operations to meet our company goals.Job Responsibilities ... shipping.Team Leadership: Manage, mentor, and develop a team of supervisors and staff to achieve operational goals while fostering a positive work environment.Safety… more
- Merck & Co. (Rahway, NJ)
- …and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and ... a vision to develop a team, demonstrated leadership skills, sterile product technical & domain expertise, effective communication skills, understanding of regulatory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to optimize brand performance and patient outcomes Product Evolution Oversee product strategy and regulatory activities related to new clinical data or ... includes products in the hemophilia and growth disorders therapeutic areas, new products in the pipeline, and products acquired through business development… more
- Merck & Co. (Los Angeles, CA)
- …limited to: Scientific and Clinical Leaders Engagement: Serve as a disease, product and cardiovascular resource while engaging with select scientific and clinical ... engage customers in deep scientific discussions consistent with our company product 's package insert and be well versed in complex Heart Failure… more
- Insmed Incorporated (San Diego, CA)
- …to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for ... Millennials™, and Best Medium Workplaces™ lists.OverviewThe Senior Manager has responsibility for the QA oversight of manufacturing build up and operations at… more
- Aequor (Framingham, MA)
- …functions to identify, prioritize, scale up, transfer, implement, validate, and file new product and process life cycle improvements. KEY RESPONSIBILITIES ... issues that arise during production. Aid in design of new processes and facilities with expertise in scale up,...changes if required. Provide CMC support and guidance for product life cycle management. Provide technical guidance and train… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …various product teams and global manufacturing sitesProvide updates to Senior Management on site validation status activitiesProvide validation training to ... in support of commercialization. Serve as a technical resource to improve product quality, reliability, and process capability. Support manufacturing to satisfy the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with the 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 ... projects for CDO & Novo Nordisk (eg Investigators and site staff , Health Systems, Contract Research Organizations and Site Management Organizations etc.)… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with the 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 ... strong and positive working relationship with OPDP reviewers. Report to Senior Director, Regulatory Affairs - Advertising & Promotion. Essential Functions Provide… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with the 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 ... projects for NACD & Novo Nordisk (eg Investigators and site staff , Health Systems, Contract Research Organizations and Site Management Organizations etc.)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for ... risk management activities for his/her portfolio. Serves as the company's senior representative with key high-level internal and external stakeholders on important… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …interactions with the FDA, EMEA, and other regulatory agencies to drive product approvals and maintain correspondence relating to compliance efficiently and with ... Affairs will participate in discussions on change controls, quality holds, on-boarding new equipment and facility upgrades. This position initially reports to the… more
- Intuit (Mountain View, CA)
- …(preferable-), payments, or other financial services How you will lead + Own a bold new product strategy to deliver our Capital offerings to customers outside of ... top strategic focus - and interact regularly with the Senior Leadership team. + Be customer obsessed, developing deep...external firms to align on and deliver mutually beneficial new offerings + Set and communicate product … more
