- Novo Nordisk Inc. (Plainsboro, NJ)
- …including readiness activities, to ensure internal/external compliance with requirements/regulations Support , coordinate, and manage root cause analysis , ... strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Represent the Manufacturing Engineering department on cross-functional teams (Manufacturing, Engineering, Technical Support and Quality groups) Performs all job ... (FAT, SAT, DQ, Commissioning, IQ, OQ, & PQ), data analysis and final report preparation Participate in the development...Ability to provide evening, nighttime, and weekend on call support as needed Technical requirements for Validation… more
- Merck & Co. (Rahway, NJ)
- …and collaborate with COE's to develop-a-digital strategy for Rahway-and support the-regional portfolio.This role will develop a plan to-utilize-data visualization, ... data analysis , data monitoring and data modeling-to enable better business...from targets and implement action items to improve performance.Apply technical skills and ingenuity to correct equipment and system… more
- Merck & Co. (North Wales, PA)
- …methods applied to designing and analyzing clinical trials in support of worldwide regulatory submissions.This position involves interaction with Medical, ... project as needed. More specifically,-Develops, coordinates, and provides biostatistical support for drug projects under the supervision of management.-Lead a… more
- Merck & Co. (Rahway, NJ)
- …of Six Sigma methodologies and structured problem-solving approaches.Experience with technical transfer and lifecycle support for medical devices ... team focused on developing and implementing product control strategies, statistical analysis , and advanced statistical methods for medical device and combination… more
- Genmab (NJ)
- …of integrated database(s), as needed, and planning and conduct of integrated analysis to support development decisions, submissions, and marketing needsSupport ... of contact related to Statistics for designated compound/indicationFollow scientific and technical progress within the field of biostatistics in drug development and… more
- Merck & Co. (Rahway, NJ)
- …broader DD&T team (eg design verification, device risk management, human factors, technical integration, assembly automation, etc.), as well as members of internal ... validation, and design control and risk management techniques to positively support and influence clinical and commercial combination product development and… more
- Aequor (Thousand Oaks, CA)
- … expertise and statistical or mechanistic modeling experience Experience in deriving technical recommendations and specifications from the analysis of measured ... Passion for proactively identifying opportunities through creative modeling and data analysis Transform ambiguous business and technical questions into… more
- Merck & Co. (Durham, NC)
- …techniques, such as root cause analysis (RCA), failure mode effects analysis (FMEA), and/or Lean Six Sigma tools. Technical writing and deviation ... a member of the Engineering, Maintenance and Site Services (EMSS) team providing support to the Durham sites.- This includes Energy Center, Vaccine Bulk and… more
- Merck & Co. (Rahway, NJ)
- …supply disruptions.Collaborate with Research Laboratories groups during New Product Introductions/ Technical Transfers and new technology.Offer on-site support at ... and Safety, Interpersonal Relationships, Lean Manufacturing, Manufacturing Processes, Manufacturing Support , Pharmaceutical Manufacturing, Regulatory Compliance, Root Cause Analysis… more
- Merck & Co. (North Wales, PA)
- …with rapidly evolving field, priorities and portfolio needsMaintains continuity of technical knowledge, study design, and analysis strategies across various ... Development Statistics, BARDS, is responsible and accountable for the end-to-end statistical support for a number our company's late-stage products in Oncology. The… more
- Merck & Co. (Rahway, NJ)
- …you will:Lead and Collaborate: Participate in and/or spearhead cross-divisional technical teams focused on late-stage clinical process development, characterization, ... biologics portfolio.Drive Innovation: Conduct laboratory-scale and manufacturing-scale studies to support commercial process validation and characterization. You'll design experiments,… more
- Merck & Co. (Rahway, NJ)
- …support the business. Effective organizational skills.-Effective communication and technical writing skillsStrong computer skills Preferred Experience and Skills: ... Management, Quality Management System Improvement, Reliability Management, Root Cause Analysis (RCA), Strategic Thinking, Technical Leadership, Technical… more
- Merck & Co. (North Wales, PA)
- …projects. -Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis ... clinical trials to world-wide regulatory application submissions and post marketing support .The incumbent is responsible for the design and maintenance of… more
- Merck & Co. (Durham, NC)
- …techniques, such as root cause analysis (RCA), failure mode effects analysis (FMEA), and/or Lean Six Sigma tools. Technical writing and deviation ... your engineering expertise and leadership skills to empower teams, solve complex technical challenges, and ensure compliance with industry standards while making a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …at least 4 years in area of specialty; pharma experience preferred Specific or technical job skills Strong Root Cause Analysis and CAPA development skills. PV ... FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved....drafting of a deviation record with robust root cause analysis utilizing Standard Problem Solving (SPS) methods and strong… more
- Aequor (Pearl River, LA)
- …experimental results and present at team meetings. Write research reports to support regulatory submissions. Read scientific and technical literature to stay ... quality. You will be part of a team to support the preclinical evaluation and clinical development of mRNA...new or current assays to improve work efficiency. Apply technical skills and functional knowledge to complete projects/ assignments… more
- Merck & Co. (Rahway, NJ)
- …& tri-specific antibodies, and fusion proteins as well as the biopharmaceutic support for the oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the ... vision to develop a team, demonstrated leadership skills, sterile product technical & domain expertise, effective communication skills, understanding of regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Summary: The purpose of this job is to provide statistical programming technical support related to R programming, R related system and technology. ... resolutions of BDM departmental (internal and external) R related analysis and programming technical issues and difficulties....apps: Contribute to strategy of R programming innovation to support BDM analysis and reporting, such as… more
- Merck & Co. (Durham, NC)
- …in Research & Development.We are seeking individuals with strong scientific and technical skills to contribute to the design, development and manufacturing of ... and quality control laboratories.The Specialist, Operations will be responsible for providing support to the manufacturing area as part of the Operations team.This… more
