- Merck & Co. (Rahway, NJ)
- …dedicated colleagues while developing and expanding your career.The Chemistry , Manufacturing & Controls (CMC) Pre-approval Pharm Executive Director is ... Director , as a senior member of the Global Regulatory Affairs and Clinical Safety: Chemistry , Manufacturing and Controls Organization (GRACS CMC), will… more
- Merck & Co. (North Wales, PA)
- …the Principal Scientist / Director is responsible for developing and implementing Chemistry , Manufacturing , and Controls (CMC) regulatory strategies for ... experience (10 years with an advanced degree), including biologics or vaccine Regulatory CMC, or development; manufacturing , testing, or licensure of biological… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Director , Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for their assigned ... function with a high degree of independence and provide regulatory oversight for assigned products, in order to optimize...Ph.D or other related doctoral degree in biological science, chemistry or related discipline. Other degrees such as master's… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Modality) Lead is responsible for the management of technology transfer of the manufacturing processes of (mAb, Drug Substance, Drug Product, or New Modality) for ... projects for (mAb, Drug Substance, Drug Product, or New Modality) manufacturing , evaluates CMC risks for appropriate escalation, recommends transition milestones and… more
- Merck & Co. (Rahway, NJ)
- …a team whose roles include the design and development of formulation, manufacturing processes, and packaging to enable phase-appropriate regulatory filings for ... team environment with key stakeholders across the organizations (Research Division/ Manufacturing Division), such as Analytical, Quality, Regulatory CMC,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Director , Product Line Technical Lead, Experimental Design and Execution We are seeking an energetic and collaborative person to ... retirement, aligned with key architectural design patternsEnsure ongoing compliance with regulatory safety, GMP and Validation requirements. Ensure all systems are… more
- Merck & Co. (Rahway, NJ)
- …relationships with key leaders and stakeholders, namely Commercialization, External Manufacturing , Quality, Regulatory , Supply Chain, Finance, Legal, Shared ... Facilities and Security. The Large Molecule Operations Sourcing Associate Director in Global Operations Sourcing Procurement supports the sourcing and… more
- Catalent (Philadelphia, PA)
- Position: Director QualityLocation: Philadelphia, PAPosition Summary: The Quality function is to build, monitor, and sustain a robust and effective quality system ... that delivers reliable, high-quality products that meet all customer and regulatory agency requirements and expectations. Components of the quality system establish… more
- Insmed Incorporated (Bridgewater, NJ)
- …New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance, the Director , Quality Operations will ... supply.Review and monitor all lab processes to ensure they follow relevant regulatory GMPs and global company policies & proceduresLead overall management of Quality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC ( Chemistry , Manufacturing , and Controls) activities of the ... for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data, authoring CMC… more
- Merck & Co. (Rahway, NJ)
- …cycle time, cost/size and number of trials, implementation of tools and regulatory framework for rapid approvals and driving Go/No Go decisions on programsServing ... for optimizing model-based development-Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, authoring … more
- Merck & Co. (Rahway, NJ)
- …Scientist is a senior scientific role tasked with working closely with the group Director to define group strategy and to lead a team of scientists in solving ... complex analytical problems at the interface of biology, chemistry , and lab informatics disciplines to enable development of biologics active pharmaceutical… more
- Novo Nordisk Inc. (Boulder, CO)
- …RNAi therapeutics, continuing its legacy as the hub for all manufacturing -related activities for GalXC™ and GalXC-Plus™ investigational therapeutics developed from ... analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder,… more
- FUJIFILM Holdings America Corporation (College Station, TX)
- …each program. The position will require frequent communication with the Chemistry , Cell Biology, Microbiology, and Quality Assurance groups to coordinate execution ... schedules and deadlines Attend daily briefings and update as needed Assist QC Director and QC Managers Ability to work cross functionally with other Quality Control… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** Reporting to the Director in Regulatory Chemistry , Manufacturing & Controls (CMC), the Senior Scientist is ... responsible for implementing Regulatory Chemistry , Manufacturing & Controls (CMC) strategies for assigned products in accordance with global regulations,… more
- Lilly (Boston, MA)
- …across internal CMC networks (Drug Product Delivery, Project Management, Quality, Manufacturing , and Regulatory ) to implement and deliver material and ... chemistry . + Experience with technical transfer of processes into manufacturing operations. + Experience with authoring regulatory submissions and responding… more
- Lilly (Indianapolis, IN)
- …+ Experience with technical transfer of analytical methods into manufacturing operations. + Experience developing global regulatory strategies ... with deep technical expertise that works collaboratively with our discovery and manufacturing colleagues. Located in Indianapolis, IN, scientists have full access to… more
- Charles River Laboratories (Ashland, OH)
- Director - Bioanalytical Chemistry Req ID #: 222459 Location: Ashland, OH, US, 44805 For 75 years, Charles River employees have worked together to assist in the ... business involved in the conduct, direction, and execution of Bioanalytical Chemistry studies. Provide scientific direction, oversight, and guidance to staff.… more
- Taiho Oncology (Pleasanton, CA)
- …or related area. + Substantial experience leading and preparing Chemistry , Manufacturing and Control (CMC) documentation for regulatory filings. + Experience ... Director , Regulatory Affairs CMC Pleasanton, CA,...Manufacturing Practices (GMP) requirements as needed. + Provides regulatory support to PAI preparation and Inspection. + Directs… more
- Takeda Pharmaceuticals (Lexington, MA)
- …to the best of my knowledge. **Job Description** **Job Title** : Associate Director , Upstream Manufacturing Operations **Location** : Lexington, MA **About the ... you bring to Takeda:** + Bachelor's degree in Biology, Chemistry or related field with 6 years relevant experience...of experience as an area Manager in a bioprocessing manufacturing environment. + Knowledge of cGMPs, other regulatory… more
