- Insmed Incorporated (San Diego, CA)
- …a program lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team ... Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewLead Analytical Development Operations function to build out the process development … more
- Eisai, Inc (Exton, PA)
- …with Facilities, Quality Assurance, Quality Control, Regulatory, and CMC Program Management departments.The Associate Director of Biologics Operations maintains ... Associate Director, Biologics Operations Upstream & Downstream, Biopharmaceutical Development is from :155,000-203,400Under current guidelines, this position is… more
- Merck & Co. (Durham, NC)
- …high-quality vaccines to the patients around the world. With our core principle of Safety First and Quality Always EMSS strives to have the safest and most compliant ... operation around the network.EMSS has an Associate Director opening for the Bulk Facility (GBF) maintenance team. The selected candidate will manage the engineering,… more
- Merck & Co. (Rahway, NJ)
- …various pipeline commercialization activities, process characterization, control strategy development , technology transfer to internal and external manufacturing ... sites, manufacturing investigations, process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific… more
- Merck & Co. (Rahway, NJ)
- …Product Formulation, Safety Compliance, Standard Operating Procedure (SOP) Development , Sterile Procedures, Strategic Management {+ 3 more}-Preferred ... Chemistry, Clinical Operations, Customer-Focused, Data-Driven Decision Making, Drug Product Development , Estimation and Planning, GMP Compliance, Management … more
- Genmab (NJ)
- …love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading the development and ... and maintain labeling documents including Company Core Data Sheets (CCDS), Core Safety Information (CSI), United States Package Inserts (USPI), Summary of Product… more
- Eisai, Inc (Nutley, NJ)
- …The role will require excellent technical skills in SAS systems and application development and experience. The Associate Director must be a highly specialized ... related technical and end user support to other areas of Data Operations, Data Management , Clinical Safety Data Review and Clinical team. The Assoc. Director of… more
- Aequor (North Creek, WA)
- …(Required): Position Summary: We are seeking an experienced, highly motivated Research Associate to join our Manufacturing Science and Technology (MSAT) lab team in ... will have experience in common mammalian upstream unit operations, either in a development /MSAT lab or in manufacturing operations. This role will support late stage… more
- Merck & Co. (Durham, NC)
- …and ensuring excellence in Compliance, Supply, Continuous Improvement, and Cost Management .--The Associate Director, External Manufacturing Operations will also ... (with External Partner).-- Compliance:-Achieve compliance goals through a risk-based approach ( Safety Regulations, Quality Assurance, Risk Management , Deviation … more
- Merck & Co. (Rahway, NJ)
- …Senior LeadersAPI Small Molecule Manufacturing and Potent Compound Handling ExperienceProcess Safety Management , Emergency Management , And Incident ... (no direct reports) to progress project related deliverables. Participate in development and review of engineering guidelines, standards, safety /environmental… more
- Merck & Co. (Rahway, NJ)
- …of statistical datasets that support multiple stakeholder groups which include clinical development , outcomes research and safety evaluation.The position is a ... Sciences), a distinguished department within our renowned Research and Development division, quantitative scientists, in partnership with other subject matter… more
- Merck & Co. (Rahway, NJ)
- …through past scientific / technical expertise).Experience in budget planning & management , establishing development strategies, and managing scientific staff ... Job DescriptionThe Mixed Modality team is responsible for the research and development of sterile & parenteral drug products for biologics, Antibody Drug Conjugates… more
- Merck & Co. (North Wales, PA)
- …analysis and reporting deliverables for global stakeholders in Early Development Statistics and global PK/PD modeling and simulation stakeholders spanning ... laboratory data.Provide technical consultation and analytical support to early development statisticians for exploratory and unplanned statistical analyses.Prepare compliant… more
- Merck & Co. (Rahway, NJ)
- …Manufacturing, Manufacturing Environments, Mechanical Apptitude, Pharmaceutical Development , Pharmaceutical Manufacturing, Pharmaceutical Quality Assurance, Process ... Manufacturing Practices) manufacturing facility in the Small Molecule Process Research and Development (SM PR&D) organization. The SSO pilot plant enables gain of… more
- Merck & Co. (Durham, NC)
- …with a team of individual contributor production direct reports including safety , quality, and daily operations;Ensure that Shift(s) objectives are achieved while ... finances, labor, employee, environment and safetyTactical and strategic Shift(s) management , including collaboration with indirect staff;Promote the behaviors and… more
- Merck & Co. (Durham, NC)
- …Process Improvements, Communication, Corrective Action Management , Data Management , Environmental Regulations, Environment Health and Safety , Fast-Paced ... Job DescriptionThe Associate Specialist, is a member of the Site...Problem Management , Process Automations, Production Optimization, Quality Management , Real-Time Programming, Software Development Life Cycle… more
- Merck & Co. (Rahway, NJ)
- …(GMP), HR Programs, Lean Six Sigma (LSS), Machinery Operation, Management Process, Manufacturing, Mechanical Apptitude, Pharmaceutical Development , ... Manufacturing Practices) manufacturing facility in the Small Molecule Process Research and Development (SM PR&D) organization. The SSO pilot plant enables gain of… more
- Merck & Co. (Durham, NC)
- …that cross into inter-related unitsResponsible for assisting in the identification, development , and implementation of new systems which enhances the operation ... to address local business, service and operational challengesQuality & Safety Compliance:Develop and execute engineering change request (ECRs), as necessary.The… more
- Novo Nordisk Inc. (Durham, NC)
- …and share better practices, to include increasing awareness of data management standards & validation to create improvements in methods, techniques, approaches ... data and digitalization efforts with respective complexity (according to the technical development pathway) and with little to no guidance from the manager.… more
- Merck & Co. (Durham, NC)
- …people that make our products. We work in the manufacturing plants with a " Safety First, Quality Always" mindset striving for continuous improvement. We work in the ... resolve problems that cross into inter-related unitsAssist in the identification, development , and implementation of new systems which enhances the operation and/or… more
