- Lundbeck (Bothell, WA)
- …mass spectrometry, and other analytical methods for therapeutic protein product analysis . The individual will have a background in protein sciences and ... including new assay development, qualification and validation, and routine sample analysis Conduct routine LC-MS sample analysis to support characterization,… more
- Aequor (Seattle, WA)
- … of experimental results.Oversees experimental design, execution, data review and analysis , document writing, and contributions to regulatory submissions.Ensures ... ScientistLocation: Seattle, WA (100% Onsite)Assignment Length: 12 months contractTop Skills: PhD in immunology, cell biology, or a related discipline (or MS with… more
- Merck & Co. (Rahway, NJ)
- …formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products ... product technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Summary Position leads complex studies in study design, statistical analysis and interpretation of results with some supervision. This position ... contract research organization (CRO) programmers and statisticians in preparing analysis files and performing statistical analyses. Additionally, this position… more
- Merck & Co. (Rahway, NJ)
- …11 years of relevant work experience in process development, or a PhD in Chemical/Biochemical Engineering (or comparable) from an accredited college/university with ... at least 6 years of relevant work experience post PhD defense.Required Experience and Skills: -For BS/MS candidates, at least 11 years of relevant work experience… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... and driving pipeline impact: population pharmacokinetics (PK) and pharmacodynamics (PD) analysis , model-based meta analysis (MBMA), clinical trial simulations… more
- Merck & Co. (South San Francisco, CA)
- …strategy and provide scientific and technical leadershipEnsure high-quality data generation, analysis , and reporting to project teams, governance bodies, and ... regulatory agencies, and manage key timelines and milestonesLead and develop a group of PhD and non- PhD researchers, drive scientific innovation, and champion… more
- Merck & Co. (Rahway, NJ)
- …analysis .Represent the mass spectrometry group in project teams.Author regulatory submission sections and responses, technical reports and scientific ... peptide mapping, intact and reduced mass, and host cell protein analysis .Advance mass spectrometry methodology for peptide mapping, intact mass, native mass,… more
- Merck & Co. (Rahway, NJ)
- …bring analytical representation and expertise to project teams and support regulatory filings (eg, INDs/IMPDs and BLAs).-The successful candidate must function well ... Quality Attributes and Quality by Design principles, and advanced data analysis for drug development applications.-The Director selects, trains, and effectively… more
- Merck & Co. (Rahway, NJ)
- …Strong background and experience in separations scienceExtensive experience with UPLC/HPLC analysis of biologics (eg SEC, RP, IEX) and/or experience with capillary ... electrophoresis (CE) analysis of biologics (eg CE-SDS, iCIEF)Extensive experience with process- and impurity-related residual assay development using molecular… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... and framework for driving Go/No Go decisions on programs and rapid regulatory approvalsFoster collaboration within QP2 to achieve results, remove barriers on… more
- Merck & Co. (Rahway, NJ)
- …Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and our ... background and experience in separations science, extensive experience with UPLC/HPLC analysis of biologics (eg SEC, RP, IEX), experience in microbiological… more
- Merck & Co. (Rahway, NJ)
- …in the pharmaceutical industry.-Required Experience and Skills:Extensive experience in analysis of biologics (separation methods such as Size Exclusion ... understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics for setting specifications.Ability to design, execute and/or… more
- Merck & Co. (Rahway, NJ)
- …development, including development strategy, study design, initiation, execution, monitoring, analysis , regulatory reporting, publication, and presentation at ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications for existing products. We… more
- Insmed Incorporated (San Diego, CA)
- …will provide clinical and scientific support to clinical development and operations, regulatory , medical affairs, drug safety, and quality assurance teams, as well ... scientific review of information to support the development and updates for regulatory documents (ie, IND submissions, IND Annual Updates, DSUR, and Investigator… more
- Merck & Co. (Rahway, NJ)
- …of clinical development, as well as process characterization and regulatory filings for successful commercialization.Improve upstream processes by increasing ... prioritization, and problem-solving skills.Stay updated on the scientific and regulatory landscape; contribute scientifically and build your reputation through… more
- Merck & Co. (Rahway, NJ)
- …of tumor size and survival.Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, authoring ... regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications (CTDs), and representing QP2-IO at regulatory … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Insmed Incorporated (San Diego, CA)
- …through manufacturing operations and culminating in the successful preparation of regulatory submissions.Execute or oversees execution of protocols to generate and ... assays.Responsible for defining and authoring defensible potency strategies for regulatory interactions (briefing books, etc) and filings (INDs/BLAs). Will act… more