- Merck & Co. (Durham, NC)
- …process, commissioning and qualification, licensure, and ramp up to full production.Durham's Lead Technician, Operations will be a leader with strong ... last several years; currently Durham employs 1,000+ people.The Durham site is supporting the expansion of vaccine manufacturing to...the manufacturing process. Individual will possess the ability to lead a team, train others and contribute to and… more
- Merck & Co. (Rahway, NJ)
- …degree of technical, project, and people management responsibility. - This SSO Facility Lead role within the SSO Pilot Plant leverages significant depth and breadth ... of scientific, technical, and operational experience to lead and support facility operations, process development activities, compliance investigations/change… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Provide support to quality systems team, ad hoc, for activities such as annual product review, site risk register, or internal quality agreements. Develops and ... of multiple myeloma. Legend Biotech is seeking Quality Compliance Lead as part of the Quality team based in...audits for all quality system areas for the manufacturing site ; write audit reports, issue audit observations and follow-through… more
- Merck & Co. (Durham, NC)
- …at the Durham site through support of MES implementation and maintenance that lead to the expansion of the Durham product portfolio.The individual in this ... people that make our products. We work in our manufacturing plants with a " Safety First, Quality Always" mindset striving for continuous improvement. We work in the… more
- Merck & Co. (Durham, NC)
- …the site 's Executive Director of Engineering, Maintenance and Site Services.GENERAL PROFILE:VMF Maintenance: Lead the engineering, maintenance and calibration ... Sterile Filling lines in VMF and related Clean Utilities.Strong technical and customer service-oriented leader to support the VMF IPT. Will lead the tactical and… more
- Merck & Co. (Durham, NC)
- …performance metrics (Schedule Adherence, Release on Time, Customer service performance, Product Lead Time, etc.).-Continuous Improvement - Accountable for ... and problem-solving skills.Preferred Experience and Skills:Demonstrated knowledge of MPS/LeanDrug Substance/ Product commercial -experienceDemonstrated experience of interacting with site… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Study Report (CSR). May review tables, listings, and figures (TLF) and CSR safety narrativesMay lead the development and updates of the Investigator's Brochure ... on decisions related to clinical trial feasibility and contributes to the site feasibility assessment from a physician's perspectiveMay provide clinical input into… more
- Merck & Co. (Rahway, NJ)
- …all submissions and associated documentation. Provides expertise as Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact ... for multiple indications simultaneouslyProvide expert advice as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact… more
- Merck & Co. (Rahway, NJ)
- …the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings, figures), the span of ... multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.The position is a key collaborator with statistics and other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Clinical Study Report (CSR). May review tables, listings, and figures (TLF) and CSR safety narratives- May lead the development and updates of the Investigator's ... on decisions related to clinical trial feasibility and contributes to the site feasibility assessment from a physician's perspective- May provide clinical input into… more
- Merck & Co. (Rahway, NJ)
- …of Scientists to deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our ... hands-on work in applying regulatory guidance and quality standards related to product release and safety . #EligibleforERP #AR&DNOTICE FOR INTERNAL APPLICANTSIn… more
- Merck & Co. (Rahway, NJ)
- …characterization such that the process is scalable without compromising stability, safety , efficacy, and delivery. During development, we leverage smart experimental ... the Biologics formulation team within Sterile and Specialty Products.Primary duties: Lead / contribute towards the new, innovative approaches for biologics sterile… more
- Merck & Co. (Rahway, NJ)
- …on assistance for daily production activities while ensuring compliance with Safety & Environmental (S&E) and current Good Manufacturing Practices (cGMPs) ... SM PR&D pipeline. Responsibilities: Under the scientific direction of a facility lead , the Operations Specialist will participate in equipment setups, raw material… more
- Merck & Co. (North Wales, PA)
- …the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings, figures), the span of ... multiple stakeholder groups which include clinical development, outcomes research and safety evaluation. The position is a key collaborator with statistics and… more
- Aequor (Thousand Oaks, CA)
- …works in partnership with the maintenance, Project Management, Engineering Technical Lead , and manufacturing to develop and oversee the operation and reliability ... works in partnership with the maintenance, Project Management, Engineering Technical Lead , and manufacturing to develop, improve and oversee the operation and… more
- Novo Nordisk Inc. (Durham, NC)
- …problem solving & project support for measuring equipment site wide. Assist the Site Metrology lead in establishing the OFP DU Metrology program is in ... solving, instrument selection, failure investigation) Attains & maintains required site operation & safety certifications Maintains training qualifications… more
- Aequor (Thousand Oaks, CA)
- …practices and parts, and drive productivity improvementRelated Activities: Participate or lead , when required, multidisciplinary site teams, eg cross functional ... oversee the operation and reliability of equipment while driving safety and quality compliance. The engineer will support the...team, root cause analysis lead . Support Lean Transformation and Excellence in Operations process… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Conduct risk assessments to prioritize investigations based on potential impact on product quality, patient safety , and regulatory compliance. Address recurring ... initiatives to enhance investigation quality, timeliness, and productivity.Key Responsibilities Co- Lead Deviation Investigations: Collaborate closely with the Quality Associate… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Team members, and peers. Harmonize with Environmental, Health, and Safety personnel, Product Development, and Quality/Manufacturing personnel. Independently ... Experience directly supervising employees is preferred. Ability to work with and lead others in a team environment. Demonstrated ability to develop and set… more
- Veolia Water Technologies & Solutions (Minneapolis, MN)
- …and utilize appropriate safety gear and protection devices. Work closely with site leadership to drive site wide excellence through a collective team ... Membrane Manufacturing Operations Leader Veolia Water Technologies & Solutions (VWTS) is...time schedules, engineering specifications, quality standards, expense budgets, employee safety and cost goals; as well as assist in… more
