- 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)
- …and combination products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The associate director will be a technical subject ... Job DescriptionJob Summary: -The Associate Director of Device Technology is a key...alignment with the company's business goals, and quality and regulatory compliance.-Essential Duties and Responsibilities:Utilize extensive experience in design… more
- Genmab (NJ)
- … drug development pertaining to statisticsExperience with the relevant regulatory requirements for biostatistics processes and SOPsExperience with regulatory ... Then we would love to have you join us!Role:The 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
- 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. (Rahway, NJ)
- …DescriptionReporting into the Director, Logistics and Distribution Technology the Associate Director, Logistics and Distribution Technology will be responsible and ... matter expert technical support for distribution and logistics of human health Drug Substance, Drug Product and Finished Goods globally.-The Packaging Technical… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …the clinical and medical aspects of new respiratory medicines, including new drug or 505(b)(2) applications. This role involves strategic leadership in clinical ... target product profile (TPP) development, due diligence projects, and clinical- regulatory compliance. ResponsibilitiesEssential Duties and Responsibilities Clinical Development: Design… more
- Merck & Co. (Durham, NC)
- …support of manufacturing science and technology for commercial vaccine products including Drug Substance, Drug Product, and Analytics.-We are seeking an Assoc. ... strong and trusting relationships with site technical operations, quality, regulatory , stability, and other stakeholders to ensure effective communication of… more
- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionJoin a dynamic, innovative team dedicated to accelerating drug discovery and development through information science. We are seeking a passionate, ... experienced Associate Director to connect scientists and stakeholders with focused...communication skills. You will bring deep understanding of the drug development process and biopharmaceutical industry, along with proven… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strong knowledge of GMPs and GCPs and is compliant with domestic and foreign regulatory requirement but may seek support on such items from time to time.Has ... working environment as well as Quality Assurance and global regulatory requirements such that identification of risks is recognized...and support in managing the forecasting and planning of drug supply needs. Can participate effectively on a cross… more
- Aequor (Thousand Oaks, CA)
- …and motivated entry-level talent who demonstrate commitment and long-term stability. Associate Supply Chain Description: As an Associate , Clinical Supply ... Chain, you will play a key role in ensuring clinical drug products are distributed globally to clinical sites, supporting patients and advancing clinical trials. You… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Associate MES Engineer as part of the Manufacturing Excellence team based in ... Raritan, NJ. Role OverviewThe Associate MES Engineer will be part of MSAT team...Procedures.Support Site Readiness of MES for FDA and/or Other Regulatory Audits / Inspections.Establish key stakeholder relationships with internal… more
- Merck & Co. (North Wales, PA)
- …procedures, SAS/MACRO, SAS/GRAPH and systems and database expertise;US and/or worldwide drug or vaccine regulatory application submission experience at the ... the statistical programming activities for multiple and/or large/complex late-stage drug /vaccine clinical development projects.Develop and execute statistical analysis and… more
- Programmable Medicine Operatin (Redwood City, CA)
- …meetings with Clinical Operations, Clinical, Clinical Supply Chian, Quality Assurance, and Regulatory Affairs Responsible for drug substance and drug ... an experienced individual to focus on leading our contract manufacturing efforts including Drug Substance and Drug Product. The successful candidate will be… 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
- Protagonist Therapeutics (Newark, CA)
- …of APIs. Develop and execute manufacturing and supply strategies of raw materials, regulatory starting materials, and drug substances that meet global ... Associate Director, API Development Protagonist Therapeutics is seeking...partnering CDMOs. Expectations Foster a collaborative culture interacting with Drug Discovery and Pre-clinical Development team during early stages… more
- Translational Research in Oncology (Los Angeles, CA)
- If you are an experienced Clinical Research Associate who is passionate about oncology research and looking to join a highly skilled and knowledgeable team, TRIO is ... clinical study sites to assure adherence to ICH GCPs, local regulatory requirements, TRIO Standard Operating Procedures (SOPs), Standard Guidelines (SGs),… more
- Aequita Bioworks (San Carlos, CA)
- …Proficiency with LIMS or ELN Responsibilities: Perform sterility testing of drug products, raw materials, and components using membrane filtration or direct ... and periodic verification of testing methods. Follow SOPs, protocols, and regulatory guidance to ensure all work performed in a compliant and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … drug development and commercialization.Ability to navigate evolving CDx-relevant regulatory guidelines and provide guidance and mentorship to junior CDx ... for any projects that definitively require a CDx for drug registration or for any project with CDPs containing...of CDx assays that are compliant with applicable global regulatory guidelines. Collaborates wtih Regulatory Affairs to… more
- Merck & Co. (Upper Gwynedd, PA)
- …the way we approach serious diseases. --The Senior Director will report to an Associate Vice President in the Oncology Clinical Research Group. Under the guidance of ... of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication. -- Responsibilities: Specifically, the Senior… more
