- Genmab (Plainsboro, NJ)
- …of operational excellence, strategic planning, and innovation implementation for the Global Clinical Drug Supply team. The individual will have the ability to ... RoleGenmab is searching for an experienced Director, Global Clinical Drug Supply to be part of Global Clinical ...and supporting this type of work will allow the individual to be at the forefront of bringing medicines… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …corporate policies, and the regulatory requirements of the US Food and Drug Administration. The individual will be responsible for implementing policies ... approves documents to release of components, raw materials and drug products.Provides troubleshooting support as neededPerformance and documentation of laboratory… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …corporate policies, and the regulatory requirements of the US Food and Drug Administration. The individual will be responsible for implementing policies ... and procedures that improve safety and productivity. Job ResponsibilitiesWrite and Implement Standard Operating Procedures according to cGMP and cGLP.Develop and validate new test methods for raw material, in-process, and finished product samples (Sterility,… more
- Aequor (Thousand Oaks, CA)
- …candidate must be local to the area M-F 8am-5pm Prioritizing candidates with synthetic drug over biologics backgrounds. The ideal candidate for this role will hold a ... the candidate should possess a strong academic foundation in small molecule drug product manufacturing, tablet and capsule production, and related unit operations.… more
- Merck & Co. (Rahway, NJ)
- …part of Our Company's Manufacturing Division, within the Bioprocess Drug Substance Commercialization (BDSC), the BioSeparation Sciences (BSS) department provides ... and laboratory capabilities in support of late-stage pipeline and commercial drug substance manufacturing processes for vaccines and biologics.-- BDSC supports… more
- Merck & Co. (Rahway, NJ)
- …& Process Development (DPPD) Team designs, develops, and commercializes novel biologic/ drug /vaccine - device enabled combination products to achieve safe and ... be able to effectively coordinate the execution of device development strategies. This individual will be expected to apply his/her knowledge of product design and… more
- Merck & Co. (Rahway, NJ)
- … discovery/development to independently provide day-to-day coaching/guidance to individual contributorsMaintaining a comprehensive understanding of global regulatory ... than) The Quantitative Pharmacology and Pharmacometrics (QP2) department drives model-informed drug discovery and development (MIDD) to routinely enable efficient … more
- Merck & Co. (South San Francisco, CA)
- …complex in vitro/ex vivo assays and mechanistic experimentation to advance early drug discovery projects from target concept through lead optimization. The candidate ... screening, as well as mechanistic studies to advance a diverse drug discovery pipeline targeting obesity, immune-metabolic, and cardiovascular disorders. In… more
- Merck & Co. (Rahway, NJ)
- …assays to help confirm engagement of therapeutic targets and understand mechanisms drug action and patient response.The Immunoassay group within the TMB organization ... is seeking a highly motivated candidate to join our team. The individual will play a critical role in the development and validation immunoassay-based assays that… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …be responsible for supporting the Manufacturing Excellence team as a technical individual contributor by providing specialist knowledge and expertise of cell and ... gene therapy processes and/or process technologies. This individual will also oversee the processes and standards to maintain and improve existing and to implement… more
- Merck & Co. (Rahway, NJ)
- …excel depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of an individual like you. To this end, we strive to create an environment of ... of generating early clinical development plan and Investigational new drug applications Developing clinical development strategies for investigational or marketed… more
- Merck & Co. (South San Francisco, CA)
- …can lead development of and supervise others in modeling strategy for drug discovery. Directors work with multi-disciplinary discovery teams to enable early, ... therapeutics. The Translational PK/PD Director will serve as an individual contributor and mentor/supervise junior colleagues, with the following responsibilities:… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …detection and management, important safety topics, and regulatory submissions. This individual will ensure proactive safety monitoring and risk management through ... the Safety Management Team framework. This individual will use strong leadership and communication skills to...to strategically manage benefit-risk throughout the lifecycle of the drug . Specific responsibilities will vary depending on the stage… more
- Merck & Co. (Rahway, NJ)
- …excel depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of an individual like you. To this end, we strive to create an environment of ... of generating early clinical development plan and Investigational New Drug applications.Developing of clinical development strategies for investigational or marketed… more
- Genmab (Plainsboro, NJ)
- …to advance Genmab's portfolio of development pipeline candidate drugs. This individual will provide strategic input and ensure operational execution of global ... (and US) submission activities. The individual will be responsible to interface directly with the global health authorities (and US FDA) as the primary contact for… more
- Merck & Co. (Rahway, NJ)
- …part of Our Company's Manufacturing Division, within the Bioprocess Drug Substance Commercialization (BDSC), the Bio separation Sciences (BSS) department ... laboratory capabilities in support of late stage pipeline and commercial drug substance manufacturing processes for vaccines and biologics.-- BDSC supports second… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and Commercial Cell Therapy Manufacturing on a modified second shift. This individual will partner with various Technical Operation functions in support of ... through safe and compliant manufacturing operations according to cGMP requirements. This individual will support the organization in its build and ramp-up of… more
- Merck & Co. (Rahway, NJ)
- …assays to help confirm engagement of therapeutic targets and understand mechanisms of drug action and patient response. The Mass Spectrometry group within the TMB ... organization is seeking a highly motivated candidate to join our team. The individual will play a critical role in the development and validation of Mass… more
- Merck & Co. (Rahway, NJ)
- …DescriptionAs part of Our Company's Manufacturing Division, within the Bioprocess Drug Substance Commercialization (BDSC), the Cell Culture and Fermentation Sciences ... group and working in conjunction with internal and external partners, this individual will support late stage and commercial large molecule program activities within… more
- Lundbeck (Bothell, WA)
- …of new product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes. Join us on our ... and other analytical methods for therapeutic protein product analysis. The individual will have a background in protein sciences and analytical techniques… more
