- Merck & Co. (Rahway, NJ)
- …(Agile, Waterfall) and tools (MS Project, RACI, Gantt)Hands-on experience with manufacturing equipment and process control; automation infrastructure design and ... and current regulatory expectationsProvide automation leadership for GMP clinical manufacturing campaigns and pilot plant operations, including ongoing system… more
- Novo Nordisk Inc. (Boulder, CO)
- …of both worlds to develop new medicines for patients. The Position The Associate Director of Drug Product Manufacturing is accountable for all clinical drug ... product manufacturing including process characterization activities to support commercialization for nucleic acid programs and will have thorough knowledge of… more
- Merck & Co. (Rahway, NJ)
- …Process , Manufacturing Scale-Up, Mentorship, New Product Introduction Process , Packaging Engineering , Packaging Equipment, Pharmaceutical Packaging, Risk ... into the Director Packaging Distribution, Components and Systems COE, the Director , Global Distribution Engineering and Technology, will be responsible and… more
- Merck & Co. (Rahway, NJ)
- …Relationship Building, Compliance Packaging, Confidentiality, Continual Improvement Process , Driving Continuous Improvement, Effective Listening, Engineering ... Standards, Key Performance Indicators (KPI), Leading International Teams, Management Process , Manufacturing Scale-Up, Medical Device Regulations, Medical… more
- Merck & Co. (Rahway, NJ)
- …require applying knowledge in drug and device product development, such as manufacturing process development and validation, design control, risk management, ... Testing, Device Development, Diversity Awareness, Drug Development, Human Factor Engineering , Manufacturing Processes, Mechanical Engineering , Mechanical… more
- Merck & Co. (Rahway, NJ)
- …Practices (GMP), Leadership, Leading Project Teams, Management Process , Manufacturing Compliance, Manufacturing Methodologies, Materials Engineering , ... Job DescriptionThe Associate Director - Device Tech Transfer is a leadership role...partners,and Technical Product Leaders, regulatory and quality.Provide Voice of Manufacturing input to early development teams to ensure needs… more
- Merck & Co. (Rahway, NJ)
- …Teamwork, Detail-Oriented, Deviation Management, Engineering Standards, Good Manufacturing Practices (GMP), Management Process , Manufacturing ... Job DescriptionReporting into the Director , Logistics and Distribution Technology the Associate ...This includes technical support to the internal and external manufacturing sites as well as Third Party Logistics providers… more
- Merck & Co. (Durham, NC)
- Job DescriptionWe're looking for a Director of Quality Assurance to lead quality across the full value chain for a late-stage ophthalmic program. In this role, ... Chain Management Team, guiding strategy, ensuring compliance, and enabling manufacturing excellence from development through commercialization. You'll partner across… more
- Merck & Co. (Ames, IA)
- …process improvement experienceRequired Skills: Audit Readiness, Drug Product Manufacturing , FDA Compliance, FDA GMP, FDA Inspections, FDA Regulatory Requirements, ... Job DescriptionDirector - Global Quality Auditing and Supplier ManagementThe Director will report to the Animal Health Global Quality Lead for Compliance and… more
- Merck & Co. (Rahway, NJ)
- …platforms such as Microsoft Sentinel for event correlation and detection engineering . Strong knowledge of SOAR technologies for orchestration and response ... GIAC (GCIH, GCFA etc.). 5+ years of experience in Detection Engineering roles for large organizations. Hands-on experience with cloud-native security tooling… more
- Novo Nordisk Inc. (Boulder, CO)
- …progress. Formulate, communicate and implement the QA strategy that supports the manufacturing and testing of clinical products at CMO partners. Plan and execute ... and operational readiness initiatives required to support clinical API internal manufacturing . Coordinate with leadership team & other relevant stakeholders to… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Director , EHS (Environmental, Health, and Safety) isa senior-level role responsible for creating ... OSHA, EPA, and other federal, state and local regulations.The Director will work with leadership and company employees to...to chemistry and biology labs as well as pharma manufacturing sites.Proven track record of developing and leading EH&S… more
- Merck & Co. (Durham, NC)
- …Electrical Power Engineering , Equipment Qualification, GMP Compliance, Good Manufacturing Practices (GMP), Leadership, Power Systems, Process Improvement ... Practice (GMP) operations for all facility shutdowns Coordinates with Site Engineering and Integrated Process Team (IPT) production planners Attends daily… more
- Cipla (Central Islip, NY)
- Job Title: Director - Procurement, Cipla North America Reports to: Head SCM, Cipla North America Job Purpose The Director of Procurement is responsible for ... and capital expenditures necessary for pharmaceutical operations across multiple manufacturing sites and Contract Manufacturing Organizations (CMOs). This… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …with quality counterparts that include Quality Leads, site Compliance Leads, Manufacturing Operations, Technical Operations, Engineering and Maintenance, Supply ... ensure harmonization, alignment and execution of regulatory guidelines across all manufacturing areas, supporting both clinical and commercial sites. This individual… more
- Merck & Co. (Rahway, NJ)
- …Negotiation, Neuropsychology, Patient Safety, Post Marketing Surveillance, Prioritization, Process Engineering , Product Lifecycle, Product Lifecycle Management ... Cognitive Psychology, Conflict Resolution, Cross-Functional Teamwork, Customer-Focused, Design Control Process , Ergonomics Consulting, Human Factor Engineering , Human… more
- Merck & Co. (Rahway, NJ)
- …product support with cross-functional partnersCoordinate with supply chain and manufacturing as needed to bring products to market efficientlyEstablish customer ... Analyst or Data ScientistAbility to work across multiple functions ( engineering , design, finance, sales, marketing)Strong problem-solving and risk-assessment skills;… more
- Insmed Incorporated (NJ)
- …Development QA activities.Support investigations and root cause analysis of product or process issues related to clinical manufacturing .Drive Quality input into ... and for the future of science, we're in. Are you?About the Role:The Sr. Director CMC QA will lead QA CMC oversight for drug products, biologics, and combination… more
- Insmed Incorporated (NJ)
- …will also work closely with quality, finance, procurement, regulatory, engineering , operations, consultants and outside vendors.What You'll Do: Lead packaging ... for commercial packaging sites and CMO'sTravel to vendor and manufacturing locations for support of packaging project activities (up...(up to 20% travel).Who You Are:BS degree in Package Engineering , Mechanical Engineering or Engineering … more
- Repligen (Rancho Dominguez, CA)
- …degree in Engineering or Life Science.7+ years Quality Engineering and/or Manufacturing Engineering experience.Demonstrates working knowledge ... within the company, customers, and suppliers.Acting as direct quality liaison with Engineering , Manufacturing , Marketing and customers.May serve as Lab Safety… more
