- Twist BioScience (South San Francisco, CA)
- The Regulatory Operations Specialist is responsible for ensuring the efficient and compliant management of regulatory documentation, with a primary focus on ... combination of education and work-related experience. Minimally 2 years of experience Regulatory Operations within a biotechnology, life sciences, or chemical… more
- Merck & Co. (Rahway, NJ)
- …Policy Implementation, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Labeling, Regulatory Operations , Regulatory Submissions, ... Required experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement… more
- Merck & Co. (Durham, NC)
- …expanding your career.We have an exciting opportunity for a Specialist to join the operations team supporting a capital project critical to Human Health at our ... responsible for providing support to the manufacturing area as part of the Operations team .This is a full-time position working Monday through Friday, dayshift… more
- Insmed Incorporated (San Diego, CA)
- …Analytical Development Operations associate director is responsible for building a team to take care of the operational aspects of analytical testing to support ... a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who...also key duties. Collaboration with R&D, Process Development, Quality Control , and Regulatory Affairs is essential, as… more
- Merck & Co. (Millsboro, DE)
- …Manufacturing Documentation, Manufacturing Operations , Manufacturing Quality Control , Media Preparation, Process Improvements, Regulatory Compliance, ... Job DescriptionOur Manufacturing Operations teams are the people that make our...of raw materials, intermediates, and finished products.Our Animal Health team offers veterinarians, farmers, pet owners and governments one… more
- Eisai, Inc (Exton, PA)
- …Development groups as well as with Facilities, Quality Assurance, Quality Control , Regulatory , and CMC Program Management departments.The Associate Director ... and close-out reports for Biologics Pilot Plant campaigns. Support providing data for regulatory documents as required.7. Ensure adherence of operations to cGMP,… more
- Merck & Co. (Durham, NC)
- …ingredient, finished product, and laboratory testing for the BCG vaccine.The Specialist, Quality Control participates in a team of analysts in the development, ... attention to detail.Previous GMP-laboratory experienceWork independently and within a team environmentPreferred:Experience with responding to regulatory questions… more
- Merck & Co. (Durham, NC)
- …is seeking a dynamic and versatile leader for External Manufacturing Operations , Drug Delivery Systems and Devices within our Manufacturing Division (Associate ... as a Virtual Plant Manager - responsible for leading a cross-functional team in oversight of our relationship with External Partners that manufacture, assemble,… more
- Merck & Co. (Rahway, NJ)
- …characterization (PC), process performance qualification (PPQ), risk assessment (RA), control strategy, process comparability reports, and/or regulatory ... validation guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal and external… more
- Twist BioScience (South San Francisco, CA)
- …Partner closely with the platform architecture and infrastructure teams, Manufacturing Operations , Quality Assurance, Process Development, and Regulatory Affairs ... of our custom, in-house developed MES solutions across our biomanufacturing operations . This critical role will drive efficiency, quality, and robust data… more
- BioAgilytix (Durham, NC)
- …operations teams to access actionable insights.Cross-Functional Collaboration and Future Team Development:Work closely with IT, lab operations , and ... the technical heavy lifting yourself while laying out the roadmap for a future team .Just as important, you'll own the last mile: turning those clean, validated data… more
- Merck & Co. (South San Francisco, CA)
- …implementing, and optimizing GenAI approaches to streamline the creation and quality control (QC) of regulatory submission documents. The candidate will be ... assessment of drug candidates. The successful candidate will join a dynamic Data Science team focused on bringing AI/ML approaches to bear to improve the speed and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …myeloma.Legend Biotech is seeking a Global Process Steward as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position is a senior ... knowledge in process development, technology transfer, process comparability, CMC regulatory guidelines, process monitoring and manufacturing operations … more
- Aequor (Thousand Oaks, CA)
- …strategies. Reporting on team and plant metrics to ensure visibility to team operations and deliverables. Representing the team at plant-wide and ... will need to demonstrate knowledge of DP technical process, manufacturing operations , scientific method, basic regulatory compliance expectations, and… more
- Merck & Co. (Rahway, NJ)
- …and business savviness as they collaborate with the formulation scientists, engineers, operations staff, quality representatives, and other team members to ... Experience with sterile GMP facility startup.Knowledge of Investigational drug regulatory requirements.Understanding of Clinical Supply Chain Operations .Current… more
- Merck & Co. (Rahway, NJ)
- …and best practices related to clinical supply planning and incorporate them into the team 's operations . - Focus on Customers & Patients. - Make rapid, ... GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate...in a particular area of expertise. - Mentors new team members and supports staff development, as needed. D… more
- Merck & Co. (Rahway, NJ)
- …develop subject matter expertise- - Knowledge of order management, supply chain operations and document control - #MSJR #eligibleforERP GCSCareer25 #VETJOBS ... as the GCS spokesperson at clinical development related meetings (i .e., Clinical Trial Team s ) and product development related meetings . The incumbent must have… more
- Tris Pharma (Monmouth Junction, NJ)
- … to develop and implement procurement strategies and operations , contract negotiations, supplier relationship management, procurement systems functionality/workflows ... our proprietary science and technology.Our science and technology make us unique, but our team members set us apart; they are the engine fueling Tris' passion and… more
- AUROBINDO (Durham, NC)
- … team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under ... customs and the FDA. The position is also required to work closely with Quality Control to make sure that the process flows smoothly from receiving the product until… more
- Insmed Incorporated (San Diego, CA)
- …do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the ... Science's Top EmployerInsmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science… more
