- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance, the Director , ... QC oversight activities for Insmed. He/she will be responsible for Quality related activities for commercial products including transition from development (Phase… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …direction and leadership for the investigations management system. Working closely with the Quality Senior Manager, this position will ensure alignment with all ... productivity.Key Responsibilities Co-Lead Deviation Investigations: Collaborate closely with the Quality Associate Director to co-lead the deviation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, ... that CMC documentation is complete, well organized, scientifically sound, of a high quality , aligned with the current regulations, and presented in a manner that… more
- Merck & Co. (Durham, NC)
- …and embrace an empowered team culture including significant interaction with manufacturing, quality , IT, and engineering groups. - The Senior Specialist for ... Job DescriptionPosition Description: Senior Specialist, Manufacturing Automation The Senior Specialist Manufacturing Automation person is primarily responsible… more
- Merck & Co. (Rahway, NJ)
- …provides a high degree of technical and project management responsibility. The Senior Specialist - Manufacturing Automation position will report to the Director ... production, utility systems and associated infrastructure.- Responsibilities of the Senior Specialist - Manufacturing Automation include the following:The automation… more
- Merck & Co. (Millsboro, DE)
- …DNREC, etc.) of animal facilities and program reviews is required.PurposeThe Associate Director /Attending Veterinarian will report to the Site Quality Head/ ... Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro...regulatory requirements for animal welfare, management of controlled substances, quality control testing according to GMP standards,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …QA at the Development Leadership teams, as appropriate and as neededInteract with senior Oncology Franchise leadership teams to ensure Quality is consistently ... the GPT, by interacting with other GxP QA functions ( GMP / IMP QA, Audit Compliance, Quality Management...impact. preferredAbility to effectively interact with and present to senior management at all levels, as well as to… more
- Novo Nordisk Inc. (Durham, NC)
- …customer requirements Ensure processes and roles are established and capable to meet quality specifications & requirements, to include GMP Compliance of the team ... our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate… more
- Novo Nordisk Inc. (Boulder, CO)
- …to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our ... manage & perform validation activities at the Boulder Pilot and Clinical GMP Plants. Handle simple to moderate complexity validation projects. Support engineers in… more
- Novo Nordisk Inc. (Boulder, CO)
- …raw materials and API candidates in our portfolio. Relationships Reports to Senior Director , Chemical Development (within the CMC team). Essential Functions ... to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our… more
- Sumitomo Pharma (Columbus, OH)
- **Associate Director , GMP Quality Control** Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of ... currently seeking a dynamic, highly motivated, and experienced individual for the position of Associate Director of GMP Quality Control, who oversees GMP … more
- Regeneron Pharmaceuticals (Troy, NY)
- We are currently looking to fill an Associate Director of Quality Auditing position. This position will be responsible for providing professional expertise, ... leadership, oversight and planning for the Regeneron Quality Auditing function, with primary emphasis on GMP...and communicating auditing Right to Operate (RTO) metrics to senior management + Ensuring the training and qualification program… more
- Lilly (Indianapolis, IN)
- …Development, or Administration is desirable. Additional Information: + Must complete ITP for Sr Director TS/MS. + No certifications required. + Tasks require ... better for people around the world. **Organization Overview:** The Sr . Director - TS/MS provides technical leadership...+ Assure API EM manufacturing processes adhere to Lilly quality expectations and stay current with ICH GMP… more
- Bristol Myers Squibb (Summit, NJ)
- … Systems, Training and Document Control programs, identifying, and assessing regulatory and quality risks during site GMP operations, and ensuring adherence to ... biologics or cell therapy commercial manufacturing facility. + Expertise in GMP compliance, Quality System and global GMP regulations; must also have… more
- Taiho Oncology (Pleasanton, CA)
- …except for Japan and Asia. For assigned projects and products, the Senior Director , Regulatory Affairs Strategy is responsible for strategic ... Sr . Director , Regulatory Affairs Strategy Pleasanton,...and Europe. Position Summary: The incumbent is the most senior regulatory person on project teams and is responsible… more
- ThermoFisher Scientific (Middleton, WI)
- …laboratory organization, providing strategic direction, leadership, and management to the biopharma GMP business. The Executive Director will own the Biopharma ... and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people...objectives and metrics. As a key member of the senior leadership team, the executive director leads… more
- Lilly (Indianapolis, IN)
- …manufacturing focused scientific capability. The Central API TSMS Director /Executive Director will serve as Manufacturing TSMS senior representative to work ... process validations, and process optimization for the small molecule portfolio. The Director will oversee technical aspects of the development of API manufacturing,… more
- Frontier Medicines (Boston, MA)
- Join Frontier Medicines on an exciting journey as our newest Senior Manager/Associate Director in CMC Development, located at either our Boston or South San ... and manage a diverse range of projects simultaneously. + Experience with quality by design (QbD), process validations and statistical design of experiments (DOE)… more
- Lilly (Indianapolis, IN)
- …strategies and manufacturing focused scientific capability. The Central API TSMS Director /Executive Director will provide technical and scientific expertise ... comprehensive knowledge of the pharmaceutical industry, Good Manufacturing Practices ( GMP ), regulatory requirements, and the essential role scientists play in… more
- Lilly (Philadelphia, PA)
- …and supply novel PET radiopharmaceuticals, ensuring adherence to timelines, quality standards, and cost targets. + Collaborate with cross-functional team ... including precursors and reference standards. + Ensure compliance with global GMP guidance and regulatory requirements, defined by FDA, EMA, PMDA, and… more
