- Merck & Co. (Rahway, NJ)
- …and combination products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems . The Associate Director will collaborate with a team ... and packaging, with specific experience in autoinjectors, prefilled syringes, and complex drug delivery systems . Proven expertise in design controls, risk… 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 ... validation guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal and external… more
- Merck & Co. (Rahway, NJ)
- …Immunochemistry, Maintenance Supervision, Mammalian Cell Culture, Manufacturing Quality Control , Manufacturing Scale-Up, Manufacturing Systems , Regulatory ... 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… more
- Tris Pharma (Monmouth Junction, NJ)
- …immediate opening for a SR. Manager or Manager, Quality Management Systems (QMS). Title commensurate with experience.Summary:This position supports, oversees and ... Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record specifications.The incumbent uses… 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
- Eisai, Inc (Exton, PA)
- …focused on the technology transfer, scale-up, and optimization of validatable biological Drug Substance (DS) / Antibody Drug Intermediate (ADI) production ... Development groups as well as with Facilities, Quality Assurance, Quality Control , Regulatory, and CMC Program Management departments.The Associate Director of… more
- Merck & Co. (Rahway, NJ)
- …and execute laboratory activities. The primary objective of the Biologics Drug Substance Commercialization (BDSC), Cell Culture Sciences department is to provide ... validation guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal and external… more
- Formation Bio (NC)
- …is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more ... technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses… more
- Merck & Co. (Rahway, NJ)
- …and Planning, Maintenance Supervision, Management Process, Manufacturing Quality Control , Manufacturing Scale-Up, Manufacturing Systems , Regulatory Compliance, ... 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… 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, ... meet immediate business objectives even through adversity. This role will support drug product in regulated, clean room environments complying with current Good… more
- Merck & Co. (Durham, NC)
- …role will contribute to the performance and results of a E2E drug substance/product department and provide technical guidance. Off-shift and weekend coverage will ... is in direct support of our Upstream Fermentation manufacturing process for Bulk Drug Substance. Focused areas of responsibility include but are not limited to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of facility and equipment for new projects and existing qualified systems within cell therapy manufacturing. The Commissioning and Qualification Project Manager ... to build strong partnerships with Engineering and Facilities, Manufacturing, Quality Control and Quality Operations to drive continuous improvements and efficiencies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …external data acquisition and validation, and tools to support project portfolio across drug programs. This role is responsible for ensuring the quality and timely ... methodologies, and skills in working with internal and external systems , CROs, and vendors. Excellent verbal/written communication, analytical, organizational, and… more
- Merck & Co. (Rahway, NJ)
- …specific role will be responsible for advancing the company's Antibody Drug Conjugate (ADC) portfolio. Correspondingly, the DCT leader will be responsible ... of DCT deliverables including - robust processes & analytics, an integrated control strategy, successful tech transfer packages, filing and approval, and a robust… more
- Aequor (Framingham, MA)
- …technology transfers to produce pharmaceutical drugs for life-saving therapies. The drug substance function within global Manufacturing Science & Technology (MSAT) ... and LCM products. Our expansive portfolio covers 17 products, 5 modalities, 3 expression systems within 12 internal and external global sites in US and EU. We will… more
- Aequor (Seattle, WA)
- …Looking for a proactive and independent thinker.Extensive experience with change control processes, document approvals, and the management of Standard Operating ... and Corrective and Preventive Actions (CAPAs) within a quality management system .Hands-on experience in the cell therapy field, particularly with CAR-T (Chimeric… more
- Aequor (Davie, FL)
- …Rate: /hr Pay rate: /hr mins interview Screening Requirements: Basic Background 12-Panel Drug Test - yes Medical Screenings: A) Vision Screen - Near, Far, Color, ... management, preferably within Pharmaceutical or regulated industry. Project Management systems /processes, Microsoft Suite of Applications (Project, Outlook, Word, Excel,… more
- BioAgilytix (Boston, MA)
- …fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You'll gain experience with a variety ... turnaround times.Analyzing, reviewing, approving, and reporting test and quality control results according to established acceptance criteria and approved… more
- Aequor (Devers, TX)
- …across the Devens campus. This may include Commercial and/or Clinical drug substance manufacturing, support of Site Engineering (Maintenance and Metrology ... activities), Supply Chain/Warehouse, Laboratories (Quality Control and Process Development), or Cell Therapy Manufacturing. Key contact for internal customers,… more
- Aequor (Thousand Oaks, CA)
- …creating or revising documents along with documenting, and driving Change Control activities, Corrective Actions, and Deviations. Own SOPs and Change Controls ... preparation, sanitization, visual inspection, analytical testing and/or single use systems . Own CAPAs and minor Deviations Participate in internal/external audits.… more
