- Daiichi Sankyo, Inc. (Bernards, NJ)
- …8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience orPhD. with 6-8 years pharmaceutical industry experience ... US FDA and EU EMA) for assigned projects with support , on CMC matters. This position supports...and 4+ years direct or related CMC regulatory experienceSuccessful track record in preparation,… more
- Merck & Co. (Rahway, NJ)
- …our Company's Process & Product Modeling Team as an Associate Principal Scientist , where you will lead the development of advanced computational models that ... scientists and engineers to create end-to-end predictive models that support drug substance and drug product manufacturing operations.Develop and apply… more
- Merck & Co. (Rahway, NJ)
- …supporting inspections with multiple agencies (FDA, EMA, JNDA, TGA).-Leadership:-Establish, manage and support CMC teams, and align resources to deliver on ... control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions. CMC RA: Experience supporting/writing regulatory… more
- Merck & Co. (Rahway, NJ)
- … filings, and demonstrated working knowledge of FDA, ICH, and other regulatory requirements for CMC .- Strong understanding of integration and partnering ... Job DescriptionPrincipal Scientist - Mixed Modalities, Sterile Product DevelopmentThe Mixed Modalities team within Sterile Product Development is responsible for… more
- Aequor (East Syracuse, NY)
- …reference standards, extended characterization, and product stability/ shelf-life. Support regulatory inspections, third-party audits, and customer ... Working knowledge and experience in the biopharmaceutical development process, GMP, PAT, CMC and regulatory guidance, ICH guidelines, and compendial requirements… 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)
- …in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination products.The incumbent must be able to lead ... validation, and design control and risk management techniques to positively support and influence clinical and commercial combination product development and… more
- Insmed Incorporated (San Diego, CA)
- …development and optimization, process characterization and clinical manufacturing investigation support . As part of this collaborative group, your professional and ... to keep you challenged and engaged. If you are a driven and astute scientist who is motivated to bring life-changing medicine to patients, then this is the… more
- Lilly (Indianapolis, IN)
- …and operational support for market registrations and post-approval submissions. The regulatory scientist will leverage CMC technical knowledge and ... need them all over the world. We are seeking Regulatory Scientist GRA CMC -Parenteral Commercial...Products to be a part of the Lilly post-approval regulatory group to support global submissions and… more
- Organon & Co. (Plymouth Meeting, PA)
- …assigned products across the product lifecycle + Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC management, as ... project timelines. **Preferred Experience and Skills** A candidate with experience in Regulatory CMC in clinical development, initial marketing application and… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Principal Scientist (Director) Regulatory CMC is responsible for Regulatory Chemistry Manufacturing & Controls ( ... portfolio of small molecule or biologic products. The Principal Scientist may also support project team goals...will directly support projects and/or coordinate with Regulatory CMC scientists in the Organon franchise… more
- Lilly (Indianapolis, IN)
- …all over the world. The Senior Advisor/Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use CMC ... around the world. Lilly is looking for post approval regulatory CMC scientists to join us in... scientist will be encouraged to demonstrate innovative regulatory strategies that support the lifecycle of… more
- Organon & Co. (Jersey City, NJ)
- …+ Execute regulatory strategies by developing, authoring, and reviewing CMC submission components and documentation to support post-approval supplements, ... strategies for assigned biosimilar projects, with a specific focus on Regulatory CMC (Chemistry, Manufacturing, and Controls) requirements. This role includes… more
- ThermoFisher Scientific (Boston, MA)
- …activities. + Perform data verification, trending, and statistical analysis to support regulatory strategy and product characterization. + Collaborate ... company, all while maintaining full-time benefits. **Key responsibilities:** + Support preparation of global regulatory submission sections, for… more
- J&J Family of Companies (Malvern, PA)
- …the identification and mitigation of CMC risks, the completion of required CMC regulatory documents and responses, creation and adherence to budget and ... are searching for the best talent for a Distinguished Scientist , CMC Team Leader, Proteins to be...development improvements across the TDS organization. They may also support or lead teams in implementing initiatives to deliver… more
- J&J Family of Companies (Malvern, PA)
- …the identification and mitigation of CMC risks, the completion of required CMC regulatory documents and responses, creation and adherence to budget and ... are searching for the best talent for a** **Distinguished Scientist , CMC Team Leader, Protein Conjugates** **to...development improvements across the TDS organization. They may also support or lead teams in implementing initiatives to deliver… more
- Astellas Pharma (South San Francisco, CA)
- ** Scientist II, Bioassay & Research** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven ... For more information, please visit our website: www.astellasgenetherapies.com. **The Role:** The Scientist II will take a lead in developing and transferring assays… more
- Lilly (Indianapolis, IN)
- …them all over the world. The Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will leverage CMC technical knowledge ... around the world. Lilly is looking for post approval regulatory CMC scientists to join us in... scientist will be expected to demonstrate innovative regulatory strategies that support the lifecycle of… more
- Lilly (Indianapolis, IN)
- …that make life better for people around the world. Lilly is looking for regulatory CMC scientists to join us in developing and bringing life-changing new ... CMC technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for clinical trials and marketing… more
- Gilead Sciences, Inc. (Foster City, CA)
- …(as ASTL) to identify molecule CQAs, design/justify/execute end-to-end control strategies, support CMC process development, issue CoTs, seek Specfication ... Gilead Sciences is seeking a talented and highly motivated Senior Scientist to join our Pre-Pivotal Biologics Analytical Operations group. Our collaborative… more
