- Legend Biotech USA, Inc. (Raritan, NJ)
- …part of the Quality team based in Raritan, NJ. Role OverviewThe QA Document Control Lead role is an exempt level position with responsibilities for supporting ... management of resources, planning and assigning work to Document Control Specialists to meet goals and deadlines.Serve as a...Specialists to meet goals and deadlines.Serve as a Document Control reviewer for new and revised procedures and documents… more
- Merck & Co. (Durham, NC)
- …product, and laboratory testing for the BCG vaccine.The Senior Specialist, Quality Control participates in a team of analysts in the development, validation, and ... equipment validation, and GMP laboratory readiness.- The Senior Specialist, Quality Control will be responsible for starting testing in new laboratories using… more
- Merck & Co. (Rahway, NJ)
- …Clinical Safety for business process management and continuous improvement.-Establish and lead assigned domain Global Process Control Boards (GPCBs), accountable ... Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs & Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as the CMC working group leader of GPT. He/she will supervise the PJ Lead ADC/Bio#2 member and is the accountable for the ADC/Bio#2 and an integral member of the ... SummaryThe Job holder is responsible for the provision of CMC project lead in the ADC/Bio#2. He/she is responsible for developing/proposing integrated CMC product… more
- Merck & Co. (North Wales, PA)
- …of trends observed in Pilot-scale process monitoring (eg, statistical process control (SPC) and/or multivariate analyses (MVA). Lead technical investigations ... or post-market commercial manufacturing vaccines and biologics. - Technical scope: Lead the hands-on execution of upstream pilot-scale experiments. Typical unit… more
- Merck & Co. (Rahway, NJ)
- …device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position ... applicable regulatory, quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device… more
- Aequor (Waltham, MA)
- …pm ESTDescription:About the department:The Genomic Medicine Unit Chemistry Manufacturing & Control (CMC) development organization is responsible for all aspects of ... software, equipment, and chemical requirements is an advantage.Primary Responsibilities: Lead by example to promote an inclusive, motivating work environment… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …standard methodology. Oversee applications support groups' system validation and change control process. Collaborate with the Services organization to ensure smooth ... transition from system implementation to maintenance. Identify, assess, and mitigate technical, regulatory, and operational risks while ensuring these systems are inspection and audit ready. Overall accountability, ensuring higher quality project outcomes with… more
- Merck & Co. (Rahway, NJ)
- …BLAs for the company's pipeline.Manage large multifaceted projects as the leader of a cross-functional team.-Ensures project results meet requirements regarding ... support of the following: process performance qualification, risk assessment, control strategy, process comparability reports, and/or regulatory submissions.Adaptability and… more
- Genmab (Plainsboro, NJ)
- …and objectives in close collaboration with business and functional teams. As security leader you are part of a global information security team with main focus ... a code development scope. This means that the security leader is expected to have profound experience in embedding...Medical Affairs, VP Regulatory Affairs, GM Genmab US, IT Lead in Japan)Peers within IT&D, such as Leadership Team… more
- Merck & Co. (Rahway, NJ)
- …medical breakthroughs. We are looking for a collaborative, self-motivated -scientific leader with expertise in downstream bioprocessing to join Biologics Process ... development.Responsibilities include, but are not limited to:Serve as a scientific leader to shape and drive innovation across the Biologics pipeline, strategy,… more
- Merck & Co. (Rahway, NJ)
- …next medical breakthrough.Our team in Rahway, New Jersey, is seeking an exceptional leader who is passionate about leading a team of Scientists to deliver analytical ... Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists. Strategic partnering… more
- Merck & Co. (South San Francisco, CA)
- …advance drug targets for the treatment of CNS regulation of appetite control , neuronal circuitry in regulation of energy balance, cellular and physiological ... energetics in the broader context of cardiometabolic disease.-Key Responsibilities: Lead projects through target identification and validation, hit finding, lead … more
- Novo Nordisk Inc. (Worcester, MA)
- …reach the people who need them most. At Novo Nordisk, we are the world leader in diabetes care and a major player in defeating other serious chronic conditions such ... strong professional relationships with Endocrinologists, positioning Novo Nordisk as a leader in the diabetes care market, understanding the local market and… more
- Merck & Co. (Durham, NC)
- …lead experience recommended WORKING RELATIONSHIPS: Reports to Quality Control Associate DirectorManages and interacts with employees within own departmentFrequent ... duties will include support of site business processes, such as change control , deviation management, audits and regulatory inspections.- The Manager will be… more
- Merck & Co. (Durham, NC)
- …Shopfloor Analytical Technical Specialist will be an energetic, technical leader with strong interpersonal, communication, and collaboration skills responsible for ... technical reports and risk assessments Author or approve Change Control documentation for complex process, validation, analytical, equipment, facility/utility and/or… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …(EMS). Relationships Reports to: Manager of Automation Engineering Essential Functions Lead , plan, organize and coordinate the execution of projects from design ... system administration preferred Knowledge, Skills, and Abilities: Instrumentation & Control Device operation and troubleshooting PPCL Programing experience is… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Management: Oversee all aspects of plant operations, including production, quality control , maintenance, and shipping.Team Leadership: Manage, mentor, and develop a ... high standards of quality in production processes, implementing quality control measures and addressing any quality issues that arise.Continuous Improvement:… more
- Novo Nordisk Inc. (Port Huron, MI)
- …reach the people who need them most. At Novo Nordisk, we are the world leader in diabetes care and a major player in defeating other serious chronic conditions such ... plans and define roles and responsibilities to ensure accountability Exercises prudent control over samples and other company property in accordance with company… more
- Merck & Co. (North Wales, PA)
- …for Product Manager - PV Case Intake and Processing. Reporting into Product Line Lead Patient Safety and Quality & Compliance, this position will be responsible for ... standards for PV processes and systems, and for implementing quality control measures to ensure data accuracy and integrity.-Collaborate with other departments:… more
