- 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
- 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
- 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
- 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
- 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
- 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...act as a program lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director… more
- 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 ... Job Description ( Required ): Role Summary: The primary goals for the...the Associate Scientist are associated with supporting formulation and drug product development for a molecule preparing for commercialization.… more
- Tris Pharma (Monmouth Junction, NJ)
- …Practices (cGMPs) procedures. The incumbent prepares, coordinates and advances required documentations, in liaison with Product Development (PD)/Quality Assurance ... 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… 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
- Merck & Co. (Rahway, NJ)
- …Flexible Work Arrangements:Not ApplicableShift:Valid Driving License:Hazardous Material(s): Required Skills:Adaptability, Adaptability, Analytical Testing , ... (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)
- …, Clinical Trial Development, Data Analysis, Decision Making, Drug Development, Intellectual Curiosity, Interdisciplinary Problem Solving, Mentorship, Neuroanatomy, ... Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and troubleshooting ability to drive effective and robust production, testing and release of product to patients.Key Responsibilities Diagnoses, troubleshoot, ... knowledge of and compliance to all applicable codes and regulations as required . Obtains and keeps current all required licensing and certifications… 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)
- …- 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. (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
- Merck & Co. (North Wales, PA)
- …statistical programming activities for multiple and/or late stage drug /vaccine clinical development projects. -Accountability predominantly includes the development ... years SAS programming experience in a clinical trial environment. Department Required Skills and Experience: Excellent interpersonal skills and ability to negotiate… more
- Merck & Co. (Rahway, NJ)
- …at a project level; ability to collaborate with key stakeholdersPosition Specific Required Skills and Experience: US and/or worldwide drug or vaccine ... data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development projects. Accountability predominantly includes… more
