- 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
- SSS Company (Atlanta, GA)
- …Administers the company environmental program. Performs establishment registration, drug /device listing, and other regulatory reporting functions. ... Primary Responsibilities - Regulatory Affairs Ensures compliance with FDA, EPA and other applicable federal, state & local regulations governing the manufacture and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Global ... design and leadership of clinical development plans, and addressing all regulatory, drug and patient safety, data, CMC, IP, patient selection, market acesss and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Position ... leads very complex studies or entire drug project in study design, data analysis and interpretation...plans with minimal supervision and authors regulatory responses and other documents with minimal supervision. This position interacts with… more
- Novo Nordisk Inc. (Boulder, CO)
- …method development and transfer of methods for oligonucleotide intermediates (IPC's) as well as drug substance and drug product release within a nonGMP lab. The ... Analytical Development as an individual contributor. Daily interaction with other peers in analytical development, process development and manufacturing teams… more
- Merck & Co. (Rahway, NJ)
- …part of the Global Clinical Development organization and has oversight over drug development aspects related to clinical pharmacology and pharmacometrics of oncology ... post-PCC to registration. Directors are leaders in the field of quantitative drug development, with a strong, integrated understanding of the strategic elements of… more
- Merck & Co. (Rahway, NJ)
- …a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned ... to equipment and facility design, system commissioning/qualification, as well as other critical activity workstreams to enable facility startup. The selected… more
- Merck & Co. (Rahway, NJ)
- …team enables the translation of preclinical candidates into non-oral drug products.Primary ResponsibilitiesDesigning and developing sterile products for biologics, ... stage development candidates will include screening and developing robust drug product composition, developing scalable process and defining primary… more
- Merck & Co. (Boston, MA)
- …and molecular design scientists who employ state of the art capabilities to drive drug design and development across the globe.- We are seeking a passionate people ... leader and accomplished computational drug hunter to lead a team of talented computational...national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. - For more information… more
- Merck & Co. (Rahway, NJ)
- …Quantitative Pharmacology and Pharmacometrics (QP2) department drives model-informed drug discovery and development (MIDD) to routinely enable efficient ... drug discovery/development and/or regulatory decisions. The Pharmacometrics group within...models, ER models, MBMA, CTS, disease progression models, and other pharmacometric analyses-Developing and maintaining a comprehensive understanding of… 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. SummaryLeadership ... support the development of biomarkers, companion diagnostic tests and other devices to enhance the value of our oncology...(Dx) Partner to communicate key RA updates from the drug side, as needed. Provide RA specific inputs into… more
