- 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)
- …NC, the Supply Chain Logistics Strategy Leader will be responsible for the development , management , and growth of our warehousing and logistics operations, both ... business activities.- Reporting directly to the Director, Supply Chain Management , the successful candidate's primary responsibilities will include varying aspects… more
- Merck & Co. (Rahway, NJ)
- …enhance performance.Maintain a strong focus on compliance and Environmental Health and Safety (EHS) to drive supply excellence.Serve as the primary technical contact ... a minimum of 7 years of relevant work experience in manufacturing or development , in the areas of process start up, technology introduction, manufacturing and/or… more
- AUROBINDO (Durham, NC)
- …that has a long history of excelling in generic pharmaceutical prouct development and manufacturing. Aurolife has a 10 year history of extraordinary manufacturing ... portfolio very quickly. The Aurolife family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality… 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
- 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
- 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)
- …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
- Aequor (Tampa, FL)
- …to management and correct where possible. Stop work where deemed necessary to maintain safety .3&plus years' experienceEducation: Associate 's degree or higher ... Carries out the practical work in the laboratory including method development , method validation and trouble shooting. Takes over responsibility for the QC part 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
