- Insmed Incorporated (San Diego, CA)
- …Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Associate Director , Quality Assurance - Analytical, GMP has responsibility ... QA oversight of Insmed Gene Therapy (GTx) analytical laboratories, review and approval of GMP analytical records. Will also provide QA support for GTx Quality … more
- Merck & Co. (Rahway, NJ)
- …the Rahway based clinical equipment, systems and facilities in accordance with GMP and Safety requirements, as well as exercising Reliability Maintenance best ... and mentoring of engineers within the group. Provide engineering and quality engineering (QE) support, ensuring facilities, utilities and equipment are maintained… more
- Merck & Co. (Durham, NC)
- …and strategic decisions related to facility start-up and stabilization. The Associate Director will ensure optimized product quality and manufacturing processes, ... Job DescriptionGENERAL SUMMARYThe Associate Director - Fermentation Technology Lead within our Bulk Facility Technical Operations organization will be responsible… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Associate Director of Quality Project Management and Strategyas part of the ... team based in Raritan, NJ. Role OverviewThe Associate Director of Quality Project Management and Strategy...support both clinical and commercial requirements in a sterile GMP environment. This role will oversee, lead and support… more
- Daiichi Sankyo, Inc. (Bernards, 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. (Rahway, NJ)
- …accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for ... cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… 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 ... change. Are you ready to make a difference? The Position The Associate Director , Process Chemistry will be responsible for the design, development and staffing of… more
- Merck & Co. (North Wales, PA)
- …pipeline acceleration and uninterrupted supply of commercial products. The Associate Director , Large Molecule (LM) Critical Reagents (CR) Operations, is a leadership ... company's growing inline large molecule product portfolio. The LM CR Operations, Associate Director will lead a team responsible for the execution of material make,… more
- Merck & Co. (Rahway, NJ)
- …project management responsibility. The Specialist -Engineering position will report to the Associate Director , Engineering and will be a member of the EF Team at the ... and equipment in the facility are ready for the GMP and non- GMP work that the scientists...safety partners and other team members to ensure the quality and safe delivery of clinical supplies, and ultimately… more
- Merck & Co. (Rahway, NJ)
- …the research division, focusing on development and clinical deliveries in a GMP piloting facility supporting our company's research division.The Oral Solids Dosage ... team at the FLEx Center in Rahway is looking for an Associate Director - Process Engineer to lead clinical supply manufacturing, scientific rigor of processes,… 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 , IT and Quality audits that may impact GMP … more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- We are currently looking to fill a Director of GMP Compliance & Inspections position. This position will work with cross-functional teams to drive activities ... that will ensure a state of continuous GMP compliance in Regeneron IOPS and to build inspection...and ensure we are performing with in compliance. The Director will also provide support during regulatory inspections and… more
- Lilly (Indianapolis, IN)
- …through effective quality oversight of Indianapolis Parenteral Manufacturing's central quality processes. The Associate Director for Site Quality ... for complaint investigation management and oversight of the IPM GMP Library within the Site Quality &... and Compliance, upon delegation of authority, the Sr. Director - Site Quality & Compliance. **Basic… more
- ThermoFisher Scientific (Seattle, WA)
- …Office **Job Description** **Position Summary** : As a Business Development Executive for GMP Labs at PPD, a part of Thermo Fisher Scientific, you will play ... and biotechnology sectors. You will collaborate with internal teams to promote GMP Lab services and ensure client success. The role demands technical knowledge,… more
- Novo Nordisk (Clayton, NC)
- …+ Minimum of three (3) years progressively responsible experience in material management &/or GMP quality , required + Experience in one or more of the following ... quality raw materials for Novo Nordisk US. Relationships Director , US Sourcing Hub. Essential Functions + Responsible for...+ API & raw materials a plus + Regulations GMP &/or ISO a plus + Pharmaceutical or other… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- We are currently looking to fill a Sr Director /Executive Director , Chief GMP Data Integrity Officer position. This position is responsible for the Regeneron ... more of the following pharmaceutical or biotech areas: Manufacturing, Quality Control, Quality Assurance, or Information Technology...amount of relevant experience for each level: + Sr Director : 15+ years + Executive Director : 20+… more
- Amicus Therapeutics (Marlow, OK)
- …is responsible for leading Amicus' Quality Operations Team, ensuring a robust GMP Quality System and compliance of our Internal and External GMP ... Executive Director , Head of Quality Operations Location...the development, implementation, and continuous improvement of the Global GMP Quality System, and ensuring the … more
- Lilly (Pleasant Prairie, WI)
- …area strategies to increase the value of Lilly products. The Senior Director , Quality Assurance, is primarily responsible for overseeing the execution ... quality support for achieving key business objectives. The Quality Senior Director is responsible for the...Quality Lead Team. + Ensure overall compliance with GMP regulations, Lilly Corporate Quality standards and… more
- Bristol Myers Squibb (Libertyville, IL)
- …Vector Quality in the US. **Job Responsibilities:** + Responsible for the Quality oversight of GMP operations at the Vector manufacturing facility, and ... assist in the continuous improvement and lifecycle management of GMP policies and quality management system, including...and lifecycle management of GMP policies and quality management system, including providing guidance and direction for… more
- Kelly Services (Dallas, TX)
- Director of Quality Management- Dallas, TX The Director of Quality Management is responsible for the overall performance of the quality assurance and ... for the continuous improvement and management of the integrated Quality Systems of the Company. + Maintain the ...regulatory guidelines. + Assist with technical matters. + Coordinate GMP & food conformance audits, by serving as the… more
