- Merck & Co. (Rahway, NJ)
- …Machine Learning, Maintenance Supervision, Manufacturing Process Validation, Manufacturing Quality Control , Manufacturing Scale-Up, Mentorship, Process ... validation guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal and external… more
- Merck & Co. (Rahway, NJ)
- …field with 3 years of relevant experience in analytical development, validation, and/or quality control , or MS degree.- - Experience and Skills - Required ... various stakeholders, including Analytical Development, Large Molecule Assay Validation, Quality Assurance, Technical Operations, and CMC Regulatory Affairs, to… more
- Merck & Co. (Rahway, NJ)
- …field with 3 years of relevant experience in analytical development, validation, and/or quality control , or MS degree.- - Experience and Skills Required At ... closely with various stakeholders, including Analytical Development, External Capabilities, Quality Assurance, Technical Operations, and CMC Regulatory Affairs, to… more
- Merck & Co. (Rahway, NJ)
- …a subject matter expert in support of sterile operations within the quality control department including isolator qualifications, sterility testing, biological ... and procedures in a GMP environment including microbiology data review and quality procedures.This position is based at the Rahway, New Jersey site.Primary… more
- Merck & Co. (Rahway, NJ)
- …a subject matter expert in support of sterile operations within the quality control department including isolator qualifications, sterility testing, biological ... and procedures in a GMP environment including microbiology data review and quality procedures. This position is based at the Rahway, New Jersey site.Primary… more
- Merck & Co. (Rahway, NJ)
- …Industrial Hygiene, Innovation, Inventory Management, Management Process, Manufacturing Quality Control , People Management, Pharmaceutical Biology, ... engineers & chemists, compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of the… more
- Merck & Co. (Rahway, NJ)
- …clinical and scientific contacts and key opinion leaders in relevant fields.Conduct quality control inspections of study protocol, study documentation files and ... Study ReportMaintain contact with all stakeholders (project leader, regulatory affairs, quality assurance etc.) and keeps them informed of the study progress.May… more
- Merck & Co. (Rahway, NJ)
- …company clinical trials and assay metadata generated from these collections.Embed automated quality control checks and validation rules directly into data ... pipelines, ensuring our data assets meet the highest standards for compliance and integrity.Support teams with reports of biomarker information using various query and database integration tools.Leverage the Microsoft Power Platform to eliminate manual… more
- Merck & Co. (Rahway, NJ)
- …development for large-scale recombinant protein expression in mammalian systemsKnowledge of Quality by Design, Process Characterization and Control Strategy ... developmentPRD #eligibleforerpRequired Skills: Biological Manufacturing, Biologics, Bioprocessing, Cell Cultures, Chromatographic Separations, Communication, Downstream Processing, Molecular Biology Techniques, Process Development (PD), Process Optimization,… more
- Merck & Co. (Rahway, NJ)
- …CMC professionals, ensuring rigorous CMC regulatory strategy and delivery of high- quality submissions for products that may include respiratory/ inhalation, peptide, ... Regulatory Policy and the Head of CMC External Advocacy in Manufacturing Quality , to monitor changes in regulatory environment with potential strategic impact and… more
- Merck & Co. (Rahway, NJ)
- …As a result, VCM Product Leaders have direct impact on cost, quality , customer service, and compliance which ultimately affects access, continuity of supply, ... product enhancements, cross-product considerations, process and method technical changes, robustness/ quality / productivity projects. Manage product supply risk through Integrated… more
- Merck & Co. (Rahway, NJ)
- …product development, such as manufacturing process development and validation, design control , risk management, material and molding, design validation to create and ... Engineering, Manufacturing Processes, Mechanical Engineering, Mechanical Testing, Medical Device Quality Systems, Microscopies, Negotiation, Optical Microscopy, Product Commercialization, Production… more
- Merck & Co. (Rahway, NJ)
- …detail-orientation with strong organizational skills and ability to deliver high- quality , timely outcomes Sustainability and Inclusion Knowledge: -Understanding of ... Management, Cross-Functional Communications, Data Analysis, Driving Continuous Improvement, Inventory Control Management, Logistics, Microsoft Office, Onboarding, Procurement, Procurement Contracts,… more
- Merck & Co. (Rahway, NJ)
- …capital projects, ensuring predictable project performance in alignment with safety, quality , cost, and schedule objectives. Manage Project Procurement Plans and ... dynamic environment.High level of detail-orientation with an ability to produce high- quality , timely outcomes.Ability to challenge the current state, solve problems… more
- Merck & Co. (Rahway, NJ)
- …packaging system design s are robust , packaging processes are efficient, and control strategies are integrated with both upstream and downstream needs. They will ... of current US, and global Regulations, ICH guidance, ISO standards, and quality system regulations for pharmaceutical packaging - Strong interpersonal skills and the… more
- Merck & Co. (Rahway, NJ)
- …Developing subject matter expertise in drying, milling operations, and particle size control , including execution of wet and dry milling experiments, is expected. ... engineer will be expected to exhibit a mindset of safety and quality compliance, which will include following current Good Manufacturing Practices (cGMPs),… more
- Merck & Co. (Rahway, NJ)
- …and key stakeholders across R&D, clinical, regulatory, marketing, manufacturing, and quality functions.Educate and build awareness of HF principles to foster ... Decisions, Cognitive Psychology, Conflict Resolution, Cross-Functional Teamwork, Customer-Focused, Design Control Process, Ergonomics Consulting, Human Factor Engineering, Human Resource… more
- Merck & Co. (Rahway, NJ)
- …packaging & device development and technology teams, supply chain, operations, quality , analytical, regulatory, and project leaders. The successful candidate will ... platforms (eg syringes, auto injectors, bottles, blisters) meet safety, efficacy, quality , and robust supply standards. Drive proactive risk management activities,… more
- Merck & Co. (Rahway, NJ)
- …sites, device development and technology teams, supply chain, operations, quality , analytical, regulatory, and project leaders. The successful candidate will ... that all platforms (eg syringes, auto injectors, kits) meet safety, efficacy, quality , and robust supply standards. Develop and maintain strong relationships with… more
- Merck & Co. (Rahway, NJ)
- …molecular biology and immunoassay techniques - Strong background in ana lyt ical control st r ategy development and execution - Demonstrated ability to develop ... Background in Analytical Methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics… more
