- Merck & Co. (Rahway, NJ)
- Job Description Lead the Future of Biologics Drug Substance Commercialization! Are you a bold, strategic thinker with a passion for biologics? We're looking for a ... dynamic and visionary-Director, Drug Substance Leader-to drive innovation and excellence across our Biologics Science & Technology (S&T) portfolio. In this… more
- Merck & Co. (Rahway, NJ)
- …global and site-specific projects, including those related to Combination Products and Drug Delivery Systems. The role includes leading, enabling or consulting in ... strategic plans for problem-solving and continuous improvement by working with internal and external partners.- The key stakeholders include our Company… more
- Merck & Co. (Rahway, NJ)
- …science and a resounding passion for improving human health through innovative drug delivery technologies and predictive analytical tools. As part of our global ... Our responsibilities range from early stage up to commercialization for both drug substance and a broad array of oral, sterile and combination products.… more
- Merck & Co. (Rahway, NJ)
- …guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal ... and execute laboratory activities. The primary objective of the Biologics Drug Substance Commercialization (BDSC), Cell Culture Sciences department is to provide… more
- Merck & Co. (Sacramento, CA)
- …such as in biologics or vaccines commercialization, technical operations, and/or Quality control .Knowledge with In-Process Controls, drug substance and drug ... for Large Molecules (Vaccines and Biologics), and Cross-Modality Compounds (ie Antibody- Drug Conjugates).This team is highly motivated, fast-paced and focused on a… more
- Merck & Co. (Rahway, NJ)
- …part of Our Company's Manufacturing Division, within the Biologics Drug Substance Commercialization (BDSC) organization, the upstream process science and ... and biologics. The group supports various cell bank and upstream drug substance process commercialization activities and second generation process development… more
- Eisai, Inc (Exton, PA)
- …with Support Services, Facilities, Biologics Process Development, Quality Assurance, Quality Control , Validation, and other internal (PST) and external functions ... focused on the technology transfer, scale-up, and optimization of validatable biological Drug Substance (DS) / Antibody Drug Intermediate (ADI) production… more
- Merck & Co. (Rahway, NJ)
- …and combination products. The individual is also responsible for managing internal and external manufacturing in the scale-up, development, commercialization, and ... and combination products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The Sr. Engineer role is a technical subject matter… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJoin Our Team as a Biologics Drug Substance & Cell Banking Leader!Are you ready to take your career to the next level? We are seeking a dynamic and ... visionary-Biologics Drug Substance & Cell Banking Leader-to spearhead our cutting-edge cell banking and biologics commercialization within the expansive Biologics… more
- Tris Pharma (Monmouth Junction, NJ)
- …Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record specifications.The incumbent uses ... and cross functionally throughout company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior Leadership, etc.) on… more
- Merck & Co. (Rahway, NJ)
- …Clinical Research, Cross-Functional Team Leadership, Data Analysis, Detail-Oriented, Drug Development, Good Manufacturing Practices (GMP), Inventory Control ... contact representing the GCS Planning organization to customers both internal and external to GCS and serves as the...the timelines for bulk manufacturing needs and release of drug product across assigned program(s).-Works directly in the SAP… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Scientists and Engineers support internal development and internal /external manufacturing operations to remain operational, continuously ... Quality.As part of Our Company's Manufacturing Division, within the Biologics Drug Substance Commercialization (BDSC) organization, the upstream process science and… more
- Merck & Co. (Rahway, NJ)
- …This program provides guidance in customs valuation methodologies and determines control processes for no-sale/free of charge shipments. CIT is also responsible ... appropriate filing of VCP related questions and documentation on the GTC's internal page.Provide feedback to operational teams on the effectiveness of the VCP… more
- Merck & Co. (Durham, NC)
- …in Durham, North Carolina. The new facility will include end-to-end processing of drug substances.As the team finishes the design and construction of the facility, ... a critical role in supporting the Operations Management team, partnering with internal stakeholders, and building the operations team.Members of the Operations team… more
- Aequor (Framingham, MA)
- …technology transfers to produce pharmaceutical drugs for life-saving therapies. The drug substance function within global Manufacturing Science & Technology (MSAT) ... Our expansive portfolio covers 17 products, 5 modalities, 3 expression systems within 12 internal and external global sites in US and EU. We will be supporting the… more
- Merck & Co. (Rahway, NJ)
- …biology, chemistry, and lab informatics disciplines to enable development of Biologics drug substances and drug products.-The successful candidate must function ... knowledge and experience with regulatory guidance and industrial standards of control strategy for residual HCPs and other process related impurities in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to build strong partnerships with Engineering and Facilities, Manufacturing, Quality Control and Quality Operations to drive continuous improvements and efficiencies ... between the Engineering group and the operating departments to address internal stakeholder needs ensuring that all asset qualification activities are properly… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to ensure the facility meets aseptic requirements for Manufacturing and Quality Control Labs. This person will communicate and provide updates 1st shift facilities ... cleaning team to ensure facility readiness for manufacturing operations and quality control labs next shift.Communicate with all key stakeholders (MFG, FAC, QC,… more
- Merck & Co. (Durham, NC)
- …seeking a dynamic and versatile leader for External Manufacturing Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate ... Quality Assurance, Risk Management, Deviation Management, Product Release, Change Control ).- Supply Chain Management:-Manage coordination with End-to-End Product Supply… more
- Merck & Co. (Rahway, NJ)
- …This individual serves as the primary GCS point of contact to stakeholders both internal and external to GCS and serves as the GCS spokesperson at clinical ... establish a consolidated, visible forecast for all study product needs (Bulk Drug Product and Clinical Finished Goods).-- Responsible for authoring clinical supply… more
