- Daiichi Sankyo, Inc. (Bernards, NJ)
- …procedures. Provide expertise and solutions to CSV questions and issues.Responsibilities- Provide Validation Lead support for Daiichi Sankyo GxP and Non-GxP ... for Daiichi Sankyo by various contractors meets Global DX Computer System Validation requirements, global regulatory compliance, and global Quality expectations.… more
- Merck & Co. (Rahway, NJ)
- …and strategic direction on the company's highest complexity programs they are selected lead to ensure high quality products and robust manufacturing processes.-- ... products and processes are developed in accordance with applicable regulatory, quality , company, and customer requirements.-This position will lead … more
- Merck & Co. (Durham, NC)
- …in supporting the manufacturing process. Individual will possess the ability to lead a team, train others and contribute to and implement process improvements.The ... Lead Maintenance Technician is responsible for providing equipment troubleshooting,...an inclusive team culture including significant interaction with Operations, Quality , Automation, Technology, and other groups as required.- Responsible… more
- Merck & Co. (South San Francisco, CA)
- …in drug discovery strategies and processes throughout target identification and validation , lead optimization, preclinical candidate selection, and early ... as mechanistic experimentation to advance drug discovery from target concept through lead optimization. The candidate will also work closely with therapeutic area… more
- Merck & Co. (South San Francisco, CA)
- …in translational cell models, mechanistic pharmacology, and biomarker and lead discovery to join our Quantitative Biosciences (Pharmacology) department. The ... experimentation to advance early drug discovery projects from target concept through lead optimization. The candidate will work closely with a team of… more
- Merck & Co. (Rahway, NJ)
- …Sterile Product Development (SPD) team. The successful candidate will be expected to lead the team focused on the design of new formulations and development of ... to the Executive Director of Sterile Product Development - Mixed Modalities, and lead a team comprised of 10-15 experienced senior and associate scientists.- The… more
- Aequor (Bothell, WA)
- …system (MES) as needed Develop standards and best practices for development and validation activities Lead cross-functional teams through design reviews and user ... AND SCOPE OF POSITION (Position Summary): The MES Recipe Engineer and Validation Specialist role will deliver electronic batch record (EBR) configuration and … more
- Aequor (Fort Worth, TX)
- …to lead and/or support research and development activities. Assist and/or lead process, laboratory, and equipment validation to support research and ... a PhD but not opposed to review their profile. Must Haves: 1. Validation experience 2. Manufacturing experience 3. Technical Writing/Lab work Reporting to the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …data collection services on behalf of Daiichi Sankyo. This position also ensures quality delivery of all 3rd party data from diverse external providers for clinical ... trials, clinical development, and regulatory submissions. The position will perform validation of the electronically transmitted external data by ensuring all… more
- Merck & Co. (Durham, NC)
- …is seeking to hire an experienced and technically proficient people manager to lead a team of coaches, production specialists, and operators through the capital ... and Alum/Sterile Supply) and cross-functional teams (ie Maintenance, Global Engineering, Quality , and Technical Operations) to ensure a successful design, technology… more
- Merck & Co. (Rahway, NJ)
- …Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and ... team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …approval by QA Manager Performs regular internal audits of NNUSBPI facilities as a lead auditor Works closely with Manufacturing and Quality Control to resolve ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...Possess signature authority for deviation closure Reviews and approves Validation Documentation Reviews and assesses Corrective and Preventive Action… more
- Merck & Co. (Rahway, NJ)
- …controls, risk analysis, control strategies, design verification testing, and process validation , with a strong understanding of quality management systems ... on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead a team of engineers and technical staff to support global and… more
- Merck & Co. (Rahway, NJ)
- …leverages significant depth and breadth of scientific and technical experience to lead small molecule drug substance process development teams to develop safe, ... and productive processes, through scale-up, tech transfer, process characterization, validation and filing.- This role involves hands-on process development at… more
- Merck & Co. (Rahway, NJ)
- …in support of the key capabilities in our global manufacturing, supply chain, quality , and operations value teams. - The position, in partnership with the Enterprise ... Division demands. Create documented architectures in collaboration with the Manufacturing, Quality , and Supply Chain Value teams. Advise value teams on modern… more
- Aequor (Thousand Oaks, CA)
- …to have process/utility Engineering technical experience and not only be quality background driven. This engineering position supports projects that associated with ... cGMP equipment and facilities at Thousand Oaks (ATO). The engineer will lead project engineering and construction activities in alignment with the engineering… more
- Merck & Co. (Rahway, NJ)
- …Division, in support of the key capabilities in our global manufacturing, supply chain, quality , and operations value teams with a specific focus on our existing SAP ... documented SAP and other system architectures in collaboration with the Manufacturing, Quality , and Supply Chain Value teams.Advise value teams on modern information… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary This position will lead the valuation processes for in-licensing, out-licensing, co-development and/or acquiring ... assessments consistent with our corporate business development strategy. This position may lead a small team and will report to the Head of Forecasting/Business… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …experience in cGMP manufacturing, operations management, tech transfer, process and equipment validation and quality management, with a preference for cell ... principles, processes, technologies, and talent management.Key Responsibilities Develop and lead an effective manufacturing and supply organization, supporting teams… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything ... to cGMPs, established manufacturing practices and procedures, and compliance with Quality regulations and guidelines. Relationships Reports to: According to the… more
