- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionGRACS CMC - Associate Principal Scientist , CMC, R4 - Pharm Pre-approval Reporting to the Sr Director/Director/Principal Scientist /Sr Principal ... Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPrincipal Scientist - Mixed Modalities, Sterile Product DevelopmentThe Mixed Modalities team within Sterile Product Development is responsible for ... products.We are seeking a highly motivated candidate for the position of Principal Scientist (R5) focused on developing parenteral drug products across a range of… more
- Aequor (East Syracuse, NY)
- Job Title: Scientist , Analytical Sciences & Technology Contract: 12 Months Location: East Syracuse, NY Job ID: 1167 Qualifications Education / Experience / Licenses ... experience in the biopharmaceutical development process, GMP, PAT, CMC and regulatory guidance, ICH guidelines, and compendial requirements is desired. Experience… more
- Merck & Co. (South San Francisco, CA)
- Job Description Senior Principal Scientist Translational Medicine, Immunology Translational Medicine in our Research & Development Division is responsible for ... point in the drug development process, working closely with scientific, regulatory , statistical, and modelling colleagues across the organization to translate the… more
- Merck & Co. (Rahway, NJ)
- …Provide technical oversight of cell culture process development, process characterization and regulatory filing activities to ensure a smooth and clear path to ... control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions.CMC RA: Experience supporting/writing regulatory filings… more
- Tris Pharma (Monmouth Junction, NJ)
- …Tris has an immediate opening for a Method Validation R&D Senior Scientist ISummary:The Method Validation (MV) Research and Development (R&D) Senior Scientist ... in liaison with Product Development (PD)/Quality Assurance (QA)/Quality Control (QC)/ Regulatory Affairs, including reviews/approvals of Change Control Reports (CCRs),… more
- Merck & Co. (South San Francisco, CA)
- …discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations).Provide clinical pharmacology ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs, and late-stage Clinical Research throughout research sites… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDevice Development Associate Principal Scientist - Development Strategy, Design Controls(Associate Director Equivalent) Our company's Device ... from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.This position will interact… more
- Merck & Co. (Rahway, NJ)
- …analytical investigations with a strong focus on quality and regulatory compliance.Excel in impurity isolation, unknown peak identification, characterization of ... leadership and collaboration.Maintain a deep understanding of the regional regulatory and business environment, including:API and Drug Product development needsGMP… more
- Merck & Co. (Rahway, NJ)
- …teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing ... clinical development, including study design, initiation, execution,- monitoring, analysis, regulatory reporting, publication, and presentation at national and international… more
- Merck & Co. (Rahway, NJ)
- …responsibility and leadership of internal and external work.The Senior Scientist , Engineering position leverages scientific/technical experience to develop safe and ... lab scales in addition to technology transfer to commercial manufacturing facilities. The scientist will be expected to exhibit a mindset of safety and quality… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director (Principal Scientist ) has primary responsibility for the planning and directing of clinical research activities involving new or marketed ... of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be responsible… more
- Merck & Co. (North Wales, PA)
- …execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on the clinical trial team.Leading medical monitoring team in review and ... engagements. This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... and quality management of submission data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development projects.… more
- Merck & Co. (Rahway, NJ)
- …in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination products.The incumbent must be able to lead ... full integration of the device development activities with the clinical, regulatory , formulation, commercial and other key company functions.Lead the Device… more
- Merck & Co. (Rahway, NJ)
- …Company's Research & Development Division is seeking applicants for a Principal Scientist position available at its Rahway, New Jersey research facility. The ... Principal Scientist is a senior scientific role tasked with working...and transfer using immunoassay techniques.Extensive knowledge and experience with regulatory guidance and industrial standards of control strategy for… more
- Merck & Co. (Rahway, NJ)
- …Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist .BPR&D within Research Laboratories is committed to rapidly delivering diverse ... with the scientific community to influence the field.As a Senior Principal Scientist , you will drive various strategic initiatives and translate strategies into-… more
- Merck & Co. (Rahway, NJ)
- …of clinical protocol(s) . This may include: Serving as the lead clinical scientist on the clinical trial team. Leading medical monitoring team in review and ... mentorship to other clinical scientists. Core Skills Solid knowledge of clinical research regulatory requirements (e . g . , GCP and ICH) Ability to manage… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJoin Our Team as an Associate Principal Scientist /Associate Director in Biologics Drug Substance Commercialization!Are you ready to make a significant ... cross-functional teams to foster collaboration and innovation.Document Excellence: Author regulatory and technical documentation, ensuring all processes align with… more
