- Aequor (Bothell, WA)
- …buffers to be used in formulation development work and to support analytical testing of antibody- drug conjugate molecules. Support analytical testing team ... for the Associate Scientist are associated with supporting formulation and drug product development for a molecule preparing for commercialization. Role… more
- Merck & Co. (Rahway, NJ)
- …& Technology (DD&T) organization designs, develops, and commercializes novel biologic/ drug / vaccine - device enabled combination products to achieve safe and ... set direction for the device development strategy for multiple drug -device combination product development programs ranging from concept generation/selection,… more
- Merck & Co. (Rahway, NJ)
- …high-volume clinical and commercial assembly equipment and processes for medical devices/ drug delivery systems. Reporting to the Director responsible for this area, ... and process development using semi-automated and automated equipment, conduct functional testing , assist in clinical batch manufacture as an equipment subject matter… more
- Aequor (East Syracuse, NY)
- …in the testing and characterization of raw materials, excipients, in-process, drug substance, and drug product samples including HPLC/UPLC methods and ... and drug product samples. The candidate will execute non-GMP testing , non-GMP stability testing , reference standard qualification, and comparability studies… more
- Tris Pharma (Monmouth Junction, NJ)
- …development and supports laboratory investigations and performance of non-routine testing such as method comparisons and evaluations.ESSENTIAL FUNCTIONS Primary ... Layer Chromatography (TLC), automatic titration, dissolution apparatus, etc.) to support sample testing Performs all laboratory analyses of raw materials, IP, FP and… more
- Tris Pharma (Monmouth Junction, NJ)
- …federal and local laws Performs validation of analytical methods and release/stability testing for raw materials, IP, FP and ST samples of pilot/pivotal/submission ... and information gathered during method validation for possible discrepanciesDocuments all testing details and results in laboratory notebooks and report sheets,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and CDx submission plan for each country/region, both before and after CDx testing , for less complex projects.At the time of implementation of a CDx study/IVDR ... performance evaluation study integration of an assay into clinical testing (before testing ) and once data is...(Dx) Partner to communicate key RA updates from the drug side, as needed. Provide RA specific inputs into… more
- Merck & Co. (Rahway, NJ)
- …, Clinical Trial Development, Data Analysis, Decision Making, Drug Development, Intellectual Curiosity, Interdisciplinary Problem Solving, Mentorship, Neuroanatomy, ... of generating early clinical development plan and Investigational New Drug applications;Developing clinical development strategies for investigational or marketed… more
- Insmed Incorporated (San Diego, CA)
- …Development Operations function to build out the process development support testing function within analytical development. Will develop systems and processes to ... facilitate rapid, high throughput testing . As the Sending Unit, will facilitate transfer of analytical procedures to a Receiving Unit (internal or external QC). May… more
- Merck & Co. (Rahway, NJ)
- …and combination products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead a team of engineers and ... late stages of development, and working collaboratively with receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality.Provide… more
- Repligen (San Diego, CA)
- …commonly used for quantifying concentrations of proteins and antibodies in drug discovery and development, manufacturing, and quality assurance. The Laboratory ... will include system qualifications for Installation and Operation (IQOQ), product testing , system maintenance and customer training. Delivering training and support… more
- Aequor (Pearl River, LA)
- …procedures and within safety guidelines in the production of Flublok Drug Substance in the downstream processing (Clarification and Purification) and buffer ... for area equipment, including biosafety cabinets, magnetic mixers, in-process testing equipment (pH / conductivity meters and turbidity meters). Secondary… more
- Merck & Co. (Rahway, NJ)
- …(FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply ... GMP standard operating procedures and protocols in support of sterile clinical drug product operations. This individual will leverage leadership skills in strategic… more
- Merck & Co. (North Wales, PA)
- …presentation skillsEducation/ExperienceBachelor's Degree +5 years of pharmaceutical, clinical drug development, project management, and/or medical field experience ... OR Master's Degree +3 year of pharmaceutical, clinical drug development, project management, and/or medical field experience OR PhD/PharmD Degree in life sciences,… more
- Merck & Co. (Rahway, NJ)
- …of generating early clinical development plan and Investigational New Drug applicationsDeveloping of clinical development strategies for investigational or marketed ... to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in internal and joint… more
- Merck & Co. (Rahway, NJ)
- …data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development projects. Accountability predominantly includes ... stakeholdersPosition Specific Required Skills and Experience: US and/or worldwide drug or vaccine regulatory application submission experience including the… more
- Merck & Co. (Rahway, NJ)
- …- Education/Experience Bachelor's Degree +5 years of pharmaceutical , clinical drug development, project management , and/or medical field experience OR Master ... ' s Degree +3 year of pharmaceutical, clinical drug development, project management, and/or medical field experience OR PhD/PharmD Degree Degree in life sciences,… more
- Merck & Co. (North Wales, PA)
- …etc.)Education/Experience: Bachelor's Degree +5 years of pharmaceutical, clinical drug development, project management, and/or medical field experience/ Master's ... degree +3 year of pharmaceutical, clinical drug development, project management, and/or medical field experience or PhD/PharmD DegreeDegree in life sciences,… more
- Merck & Co. (North Wales, PA)
- …statistical programming activities for multiple and/or late stage drug /vaccine clinical development projects. -Accountability predominantly includes the development ... include coordinating the activities of a programming team.US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level… more
- Merck & Co. (Rahway, NJ)
- …establish a consolidated , visible forecast for all study product needs (Bulk Drug Product and Clinical Finished Goods).- - Responsible for authoring clinical supply ... Participate in Interactive Voice Response (IVR) System d evelopment and User Acceptance Testing (UAT) for assigned studies . - Mentors new team members and supports… more
