- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Microbial Process Operations (MPO) Team is seeking a Senior Principal Scientist with expertise in microbial process development for the production ... biomolecules, including novel biotherapeutics, vaccines, and engineered enzymes.As a senior scientific leader, the successful candidate will shape strategy, drive… more
- Merck & Co. (Rahway, NJ)
- …Sciences, Process Design, Process Hazard Analysis (PHA), Process Optimization, Proper Documentation , Regulatory Compliance, Regulatory Requirements {+ 4 ... MES, SCADA, DCS, and OEM systems-Work with process development teams on technical development and the testing of new technologies, trialing new automation… more
- Insmed Incorporated (San Diego, CA)
- …and interpret experimental data, contributing to reports, presentations, and regulatory documentation .Maintain accurate electronic laboratory notebooks and ... of science, we're in. Are you?About the Role:Insmed is seeking a Senior Research Associate - Lab Technician with specialized expertise in supporting preclinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Genmab (NJ)
- …a fit? Then we would love to have you join us!The RoleThe Senior Manager, Clinical Programming is responsible for the establishment, governance, and integrity of ... study or portfolio-level SDTM datasets are in compliance with CDISC and regulatory submission requirements, reviews study submission data packages to ensure quality… more
- AdaptHealth LLC (Philadelphia, PA)
- …ensuring your CV and skills are a good match. Position Summary: The Senior Internal Auditor - Business Systems is responsible for supporting and executing internal ... while developing expertise in control evaluation, risk assessment, and regulatory compliance frameworks. Essential Functions and Job Responsibilities Audit Planning… more
- Insmed Incorporated (NJ)
- …of regulatory submissions including INDs, NDAs/MAAs, and other required documentation . Ensuring compliance with ICH, FDA, EMA, PMDA and other international ... for patients with serious diseases. Reporting to the SVP, Technical Operations, you will lead all Chemistry, Manufacturing, and...activities for the company's small molecule pipeline. As a senior leader, you will oversee drug substance and drug… more
- Insmed Incorporated (NJ)
- …you?About the Role:The Director, EHS (Environmental, Health, and Safety) isa senior -level role responsible for creating and implementing programs that ensure ... workplace safety, regulatory compliance, and environmental protection for all Insmed locations.Key...audits and surveys, analyze results, and provide reports to senior management and other stakeholders.Advise senior leaders… more
- Insmed Incorporated (NJ)
- …role will manage cross-functional teams and ensure compliance with regulatory requirements while maintaining operational excellence. The Executive Director, ... building and protecting secure digital environments. The ideal candidate combines deep technical expertise with a proven ability to communicate complex risks in… more
- Cipla (Hauppauge, NY)
- …and analyze all data, write final reports and obtain approvals. Review technical documentation such as batch records, SOPs, calibration records, preventive ... English language communication skills verbally, written, and interpersonally. Must possess strong documentation and technical writing skills, and able to apply… more
