- HSBC (Buffalo, NY)
- US Technology Regulatory and Controls Manager Brand:...trigger events related to US technology controls and advise US control owners ... Controls Manager role will be part of the US Technology Regulatory and ...technology to identify risks and improvements to the control environment + Maintain and continuously improve governance and… more
- Merck & Co. (Rahway, NJ)
- …stakeholders, such as packaging and 3rd party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate ... Job DescriptionReporting into the Director, Logistics and Distribution Technology the Associate Director, Logistics and Distribution Technology will be… more
- Syner-G BioPharma Group (Boston, MA)
- …applicants who will be able to travel remotely throughout to client sites in the United States . WORK LOCATION: Travel to client sites will be required up to ... phases of the drug development lifecycle, from discovery and regulatory approval to technology transfer and the...our team members are our most valuable asset. Join us in shaping the future, where your talents are… more
- SMBC (New York, NY)
- …Tokyo Home Office, Finance & Operations, Risk, HR, Internal Audit, and Technology . The Regulatory Governance team collaborates with internal support functions ... the Americas, SMBC Group has a presence in the US , Canada, Mexico, Brazil, Chile, Colombia, and Peru. Backed...of Defense regarding a broad range of compliance and regulatory issues and works hand-in-hand with business/function partners to… more
- Syner-G BioPharma Group (Boston, MA)
- …industry, supporting critical phases of the drug development lifecycle, from discovery and regulatory approval to technology transfer and the support in capital ... strategic partner for life science companies. We provide integrated regulatory and biopharmaceutical development services spanning early development to post-market,… more
- Merck & Co. (Rahway, NJ)
- …Processing, Fermentation Process Development, Mentorship, Microbial Fermentation, Process Analytical Technology (PAT), Process Scale Up, Regulatory Compliance, ... delivery of project deliverables.Collaborate with cross-functional teams to support technology transfer, scale-up activities, and process robustness.Mentor junior scientists… more
- Merck & Co. (Rahway, NJ)
- …requirement management, design verification, automation/process development, design validation, and control strategy.Knowledge of US and global medical device ... products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …OverviewThe Sr. Director of Quality will lead Legend CAR-T manufacturing facilities within the United States and ensure the sites operate in full compliance with ... the Quality Lead in support of cell therapy manufacturing and operations within the United States .Provide leadership and build an exceptional team to manage the… more
- Merck & Co. (Durham, NC)
- …Process Simulation, Product Formulation, Quality Assurance Processes, Quality Operations, Regulatory Submissions, Risk Assessments, Risk Control Assessment, ... -At the Durham Vaccine Facility in Durham, North Carolina, the Global Vaccine Technology & Engineering (GVTE) Team is seeking candidates to fill IPT Engineering… more
- Merck & Co. (Durham, NC)
- …with face-to-face presentation of technically complex subjects to regulatory inspectors-Required Skills: Adaptability, Adaptability, Biodesign, Change Control ... over the last several years; currently Durham employs 1,000+ people.Durham's Technology Transfer Specialist will be an energetic, technical leader with strong… more
- Merck & Co. (Durham, NC)
- …industry standards Lead company and site preparation activities for support of regulatory and customer inspections Provide compliance advice to site, development and ... Experience and Skills: Minimum of five (5) years of manufacturing, technology , laboratory, and/or quality operations experience within GMP environment GMP Compliance… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …provide process knowledge and expertise in support of GMP investigations, change controls , document control , process improvement, process validation and data ... we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell… more
- Merck & Co. (Rahway, NJ)
- …Biology, Process Analytical Technology (PAT), Professional Networking, Quality Control Management, Regulatory Affairs Compliance, Regulatory Compliance, ... and chromatography.Collaborate with cross-functional teams, including research, development, quality control , and regulatory affairs, to ensure comprehensive… more
- HSBC (Buffalo, NY)
- …Onboarding and Know Your Customer (OBKYC) Americas Brand: HSBC Area of Interest: Technology Location: Buffalo, NY, US , 14210 Work style: Hybrid Worker Date: ... provides both strategic and operational leadership, ensuring delivery excellence, adherence to regulatory and internal control standards, and alignment with the… more
- Labcorp (Jacksonville, FL)
- …Requirements: Bachelor's degree in Biology, Chemistry, Clinical Laboratory Science, Medical Technology or meet local regulatory (CLIA & State) requirements ... regarding testing and problem solving. Prepare, test and evaluate new reagents or controls Report accurate and timely test results in order to deliver quality… more
- Labcorp (Pensacola, FL)
- …Degree in a Chemical or Biological science, Clinical Laboratory Science, Medical Technology or meet local regulatory (CLIA & State) requirements Minimum ... to ensure proper functionality Prepare, test and evaluate new reagents or controls Report accurate and timely test results in order to deliver quality… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell ... scope includes working on Quality related sub-teams such as change control sub-teams and investigational sub-teams. The material/ raw material scope includes… more
- Tris Pharma (Monmouth Junction, NJ)
- …spanning neuroscience and other therapeutic categories employing our proprietary science and technology .Our science and technology make us unique, but ... Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned US biopharmaceutical company with a focus on development and commercialization of innovative… more
- Twist BioScience (South San Francisco, CA)
- …Company's revenue accounting policies and procedures, ensuring compliance with all regulatory requirements and SOX controls .Prepare ad-hoc revenue analysis, ... receivables and invoicing processes, improving accuracy and compliance.Work with Information Technology (IT) and other business leaders to define IT solution… more
- Merck & Co. (Durham, NC)
- …validation testing support, supporting root cause investigations and change control activities. Actively supports, participates and embraces an inclusive team ... culture including significant interaction with operations, quality, automation, technology , and other groups as required.Key Duties:Ability to perform routine… more
