- Merck & Co. (Rahway, NJ)
- …and cell-based potency assays that reflect the MOA of antibody, ADC and/or other biological drug modalities.Hands on experience with development of immunoassays, ... method development, optimization and transfer of immune- and cell-based assays for drug substance and drug product release, stability, and characterization that… more
- Tris Pharma (Monmouth Junction, NJ)
- …safety presentations, as applicable Actively participates in meetings with FDA and other Health Authorities, as required; Represents Drug Safety, establishes and ... have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.Our science and… more
- Merck & Co. (Durham, NC)
- …submission, PAI, and ultimately the commercial manufacture of the product's Drug Substance.-GENERAL PROFILE Provides leadership and direction to ensure that short ... intended to describe the general nature of the job that may include other duties as assumed or assigned.-NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers'… more
- Yakima Valley Farm Workers Clinic (Cowiche, WA)
- …Patient Counseling Drug Regimen Review Medication Therapy Management Collaborative Drug Therapy Management or other post-diagnostic disease state management, ... pursuant to a valid agreement Prescribe a drug or device, as authorized by statute according... or device, as authorized by statute according to Drug Therapy Management Protocols Orders, interprets, and monitors laboratory… more
- Insmed Incorporated (Bridgewater, NJ)
- …quality and regulatory compliance related to Good Pharmacovigilance Practices (GVP) and other related activities performed by Drug Safety & Pharmacovigilance and ... and national standards, regulations, and guidelines in partnership with Drug Safety and Pharmacovigilance (DSPV) representative. ResponsibilitiesAdditional representative responsibilities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …reconciliation) and liaise with internal Functions within the study team to ensure drug destruction process and other study close out activities are ... primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.SummaryThe incumbent… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …reconciliation) and liaise with internal Functions within the study team to ensure drug destruction process and other study close out activities are ... is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The… more
- Insmed Incorporated (Bridgewater, NJ)
- …self-motivation, and enthusiasm.Must be thoroughly knowledgeable on cGMP's, and familiar with other Regulatory Requirements applicable to a drug , medical device ... for final product Quality release/rejection and related processes.Partner with other Regional Quality Directors to ensure transparent communication and assess… more
- Merck & Co. (Rahway, NJ)
- …In summary, our team enables the translation of preclinical candidates into non-oral drug products. Our team is looking for a strong candidate for the position ... that will include ensuring screening and development of robust drug product composition, scalable process, primary packaging, compatibility characterization for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary The Technology ... Management (mAb, Drug Substance, Drug Product, or New Modality)...analytical, shipping logistics). Interface with various site locations globally, other functions in the Technology Unit, and key business… more
