- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and approvalsExtensive experience developing companion diagnostics and devices.Experience of drug development and drug regulatory procedures.Understanding ... of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device...deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization process.Experience with developing… more
- Merck & Co. (Rahway, NJ)
- …process change requests and deviation reports while ensuring regulatory compliance.Education and Minimum Requirements:Bachelor's degree in engineering, chemistry ... Relationships, Lean Manufacturing, Manufacturing Processes, Manufacturing Support, Pharmaceutical Manufacturing, Regulatory Compliance, Root Cause Analysis (RCA), Stakeholder Engagement, Stakeholder… more
- Merck & Co. (Rahway, NJ)
- …in cell culture commercialization. The primary objective of the Biologics Drug Substance Commercialization (BDSC), Cell Culture Sciences department is to provide ... process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific and administrative direction of the… more
- Merck & Co. (Rahway, NJ)
- …development of novel small molecules, biologics, and vaccines for infectious diseases. The Associate Director is a skilled quantitative drug developer, with a ... strong, integrated understanding of the strategic elements of drug discovery and development. The Associate Director should demonstrate collaborative work spirit… more
- Merck & Co. (San Francisco, CA)
- … drug discovery and development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within ... Pharmacokinetics, Pharmacology, Pharmacometrics, PKPD Modeling, Population Pharmacokinetics, R-Studio, TeamworkPreferred Skills: Drug Discovery Process, Global Regulatory , Machine Learning,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJoin Our Team as an Associate Principal Scientist/ Associate Director in Biologics Drug Substance Commercialization!Are you ready to make a ... forefront of innovation in the-Manufacturing Division, specifically within the-Biologics Drug Substance Commercialization (BDSC) team. Our Downstream Purification-department is… more
- Merck & Co. (North Wales, PA)
- …that include coordinating the activities of a programming team.US and/or worldwide drug or vaccine regulatory application submission experience at the leadership ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Insmed Incorporated (San Diego, CA)
- …lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to take care of ... Development Team representative as an Analytical Lead for a drug program.Key Responsibilities:Responsibilities include developing and optimizing analytical methods… more
- Genmab (NJ)
- … drug development pertaining to statisticsExperience with the relevant regulatory requirements for biostatistics processes and SOPsExperience with regulatory ... we would love to have you join us!The RoleThe Associate Director acts as a statistical expert supporting the...and technical progress within the field of biostatistics in drug development and advise of new methodologies that may… more
- Merck & Co. (Rahway, NJ)
- …as a lead GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines ,- strategies ... accountable for establishing the timelines for bulk manufacturing needs and release of drug product across assigned program(s) . - Works directly in the SAP system… more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for ... portfolio of products. The lead may also be responsible for supporting various regulatory policy and/or intelligence deliverables. This role will be within Global … more
- Merck & Co. (North Wales, PA)
- …engagements. This includes the ability to:--Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH) Proven ability to manage competing ... Word, Outlook, etc.)Education/ExperienceBachelor's Degree +9 years of pharmaceutical, clinical drug development, project management, and/or medical field experienceOR Master's… more
- Merck & Co. (Rahway, NJ)
- …Skills: Experience with sterile GMP facility startup.Knowledge of Investigational drug regulatory requirements.Understanding of Clinical Supply Chain ... (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking a Warehouse Operations Associate III as part of the Technical Operations team based in Raritan, NJ. ... efficient utilization of the warehouse space. This individual will assist in regulatory inspections, perform safety and quality audits, and answer relevant questions… more
- Eisai, Inc (Exton, PA)
- …Development groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of ... your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is...the technology transfer, scale-up, and optimization of validatable biological Drug Substance (DS) / Antibody Drug Intermediate… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Pediatrics will focus on driving strategy, development, and life-cycle ... the external community (Key Scientific Leaders, Patient Community, Payers, Regulatory Agencies)Responsible for managing, coaching, and mentoring Clinical Directors… more
- Merck & Co. (Boston, MA)
- …for all TK-related issues pertinent to the development of assigned drug candidates and closely interact with toxicology study directors, project representatives, ... bioanalytical scientists, drug metabolism and translational modeling representatives, and other relevant functional areas.Serve as a contributing scientist on… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for the ... credibility and ensure operational excellence (20%) Ensure compliance with regulatory and other ethical guidelines relevant to the pharmaceutical industry,… more
- Merck & Co. (Durham, NC)
- …is seeking a dynamic and versatile leader for External Manufacturing Operations, Drug Delivery Systems and Devices within our Manufacturing Division ( Associate ... for all dealings between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a strong… more
- Merck & Co. (Rahway, NJ)
- …team is responsible for the research and development of sterile & parenteral drug products for biologics, Antibody Drug Conjugates and Small Molecules, including ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
