- Nuvalent, Inc. (Cambridge, MA)
- …Role: Reporting to the Senior Medical Director , Pharmacovigilance, the Associate Director , Drug Safety and Pharmacovigilance Scientist is responsible for ... reports. This individual is expected to provide interpretation and summaries of drug safety information and provide input in the generation of safety … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Technical Lead, you will report into Director , Chemical Technical Operations, External Manufacturing API Technology, and play a pivotal role in ... enhance performance.Maintain a strong focus on compliance and Environmental Health and Safety (EHS) to drive supply excellence.Serve as the primary technical contact… more
- Merck & Co. (Rahway, NJ)
- …drugsAnalyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical ... Job DescriptionThe Senior Director (Sr. Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or… more
- Merck & Co. (Rahway, NJ)
- …and inclusive work environment.Essential Knowledge, Duties & Responsibilities for the Director Include:Sterile drug product development concepts, tools, and ... team is responsible for the research and development of sterile & parenteral drug products for biologics, Antibody Drug Conjugates and Small Molecules, including… more
- Formation Bio (New York, NY)
- …pioneer the development of sophisticated models to predict clinical outcomes-determining drug efficacy, safety profiles, and optimal indications-to create a ... is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more… more
- Merck & Co. (Rahway, NJ)
- …devices and combination products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead a team of engineers ... Job DescriptionJob Summary: -The Director , Combination Product Commercialization is a key leadership...stages of development, and working collaboratively with receiving sites, drug product partners, and Technical Product Leaders, regulatory and… more
- Insmed Incorporated (San Diego, CA)
- …on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to take care of the ... Development Team representative as an Analytical Lead for a drug program.Key Responsibilities:Responsibilities include developing and optimizing analytical methods… more
- Merck & Co. (Rahway, NJ)
- …and change management.Familiarity with United States and European Union GMP and Safety compliance regulations.Ability to convert new drug product attributes and ... (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply… more
- Merck & Co. (Rahway, NJ)
- …developing, and scaling-up the formulation, device, and manufacturing process.- Driving drug product design from the benchtop to current Good Manufacturing Practice ... manufacturing facilities, our scientists use cutting edge science to transform drug delivery and manufacturing technology to positively impact patients.The … more
- Tris Pharma (Monmouth Junction, NJ)
- …(FDA), Drug Enforcement Administration (DEA), and Occupational Health and Safety Administration (OSHA) regulations, as well as all applicable company compliance ... in our Monmouth Junction, NJ facility for an experienced, hands-on SR. Director / Director , Procurement. Title and salary commensurate with experience. The … more
- Genmab (NJ)
- …the CSRAttend trial and investigator meetings if/as neededCollaboration with Genmab Global Drug Safety :Participate in definition, review, and approval of data ... would love to have you join us!The RoleThe Associate Director acts as a statistical expert supporting the clinical...and technical progress within the field of biostatistics in drug development and advise of new methodologies that may… more
- Genmab (NJ)
- …have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading the development and maintenance ... will be within Global Regulatory Affairs (GRA) and will report to the Sr. Director , Labeling, Policy and Intelligence. The position may be based in our Princeton,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …experience in PV; required10 or more years of experience within Drug Safety /Pharmacovigilance experience, including both investigational and marketed products; ... oversight groups for case processing activities and reports to the Director of PV Case Management.Responsibilities:ICSR Processing: Oversees QC activities, supports… more
- Eisai, Inc (Exton, PA)
- …If this is your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading and building a ... focused on the technology transfer, scale-up, and optimization of validatable biological Drug Substance (DS) / Antibody Drug Intermediate (ADI) production… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as R shiny apps for data surveillance, visualization, modeling and simulations, and safety signal detection. Lead the development and validations of R package and/or ... R capabilities and implementations. Collaborate with CSPV to enable/effectively support safety signaling detections and across compounds safety reviews (ie,… more
- Merck & Co. (Durham, NC)
- …is seeking a dynamic and versatile leader for External Manufacturing Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate ... Director ).-This role serves as a Virtual Plant Manager -...Biologic, and Vaccine Products. Our team works with a " Safety First, Quality Always" mindset.-As the primary point of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the vision and ... investigational sites. Additionally, this position possesses adequate knowledge of drug development in pharmaceutical industry across different disease areas, and… more
- Merck & Co. (Rahway, NJ)
- …in cell culture commercialization. The primary objective of the Biologics Drug Substance Commercialization (BDSC), Cell Culture Sciences department is to provide ... regulatory submissions.-Under the general scientific and administrative direction of the Director in Biologics Cell Culture Sciences group and working in conjunction… more
- Merck & Co. (Durham, NC)
- …role will contribute to the performance and results of a E2E drug substance/product department and provide technical guidance. Off-shift and weekend coverage will ... is in direct support of our Upstream Fermentation manufacturing process for Bulk Drug Substance. Focused areas of responsibility include but are not limited to… more
- New Story Schools (Mountville, PA)
- Job Title: Director of Speech Therapy Services Location: Remote in Lancaster, PA 17601 Employment Type: Full-Time (Monday to Friday) Salary: Based on education and ... confidence, and independence in a supportive school environment. Your Role as Director of Speech Therapy Services Strategic Leadership & Vision: Drive the vision… more