- Actalent (Princeton, NJ)
- …industry. + Strong knowledge of batch record review, aseptic operations, and cGMP regulations. + Proficient in investigation tools like Fishbone diagrams, 5 Whys, ... and FMEA. + Ability to lead and close complex quality investigations. + Willingness to work in ISO 7 environments. + Flexibility to travel between facilities and work varying hours. Work Environment Be part of a growing CDMO specializing in Cell/Gene Therapy… more
- Merck (Rahway, NJ)
- …Global and regulatory requirements and execute current Good manufacturing Practices ( cGMP ) in the performance of day-to-day activities and all applicable job ... functions. + Work collaboratively to drive a safe and compliant culture. **Core Competencies:** + **Development and Commercialization Experience** : Demonstrated expertise of technical aspects and interdependencies across DS, DP, Device, Packaging, and… more
- Merck (Rahway, NJ)
- …Material(s):** n/a **Required Skills:** Adaptability, Adaptability, Bioreactors, cGMP Regulations, Chemical Engineering, Chemical Manufacturing, Chemical Technology, ... Chromatographic Techniques, Clinical Judgment, Communication, Design of Experiments (DOE), Detail-Oriented, Deviation Investigations, Good Manufacturing Practices (GMP), Manufacturing Processes, Process Design, Process Optimization, Process Scale Up, Quality… more
- Hovione (East Windsor, NJ)
- …in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. Promotes the scientific excellence and innovation in the Analytical area ... and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios. - Perform and provide support to the development of analytical methods and the implementation of innovative and new analytical methodologies -… more
- Hovione (East Windsor, NJ)
- …example of professionalism - Ensure activities are carried out in compliance with cGMP , HSE, cGDP and all other required processes, legal requirements in the country ... of operation, complying with and enforcing all Hovione processes and good practice - Prepare the reception, storage and shipments of all materials and products - Sample the raw materials for QC and R&D (as required) testing - Dispense raw materials in line… more
- Hovione (East Windsor, NJ)
- …of pharmaceutical product development * Possess solid knowledge of pharmaceutical cGMP and regulatory requirements * Good communication skills (verbal and written) ... * Proactive, dynamic self-starter who is a team player and communicates effectively at all levels * Skilled at managing processes and tools * Fluency in English is a requirement * Must have strong technical problem-solving skills, a commercial sense, be… more
- Sokol Materials & Services (Skillman, NJ)
- …of new biopharmaceutical manufacturing facilities. + Basic knowledge of cGMP 's and multi-national biopharmaceutical/cell therapy regulations. + Basic knowledge of ... facility/clean room design, process, equipment, automation, and validation. + Intermediate strong verbal/written communication skills and ability to influence at all levels. + Intermediate ability to think strategically and to translate strategy into actions.… more
- Merck (Rahway, NJ)
- …**Required Skills:** Accountability, Accountability, Biological Engineering, cGMP Compliance, Chemical Engineering, Communication, Cross-Cultural Awareness, ... Customer-Focused, Data Analysis, Detail-Oriented, Employee Training Programs, Ethical Standards, GMP Compliance, Immunochemistry, Implement Training Programs, Knowledge Base Management, Management Process, Mentoring Staff, Microbiology, People Leadership,… more
- System One (Cranbury, NJ)
- …from various locations throughout the company, including current Good Manufacturing Practices ( cGMP ) area + Sweeps and cleans floors as required and maintain other ... areas as needed in a neat and orderly fashion + Keeps manufacturing , lab, cafeteria and office areas clean at all times + Empties plastic bags from trash receptacles, tie and transport + May be required to ensure adequate supplies are in stock + May transport… more
- System One (Summit, NJ)
- …electronic system operations. Requirements + In-depth understanding of Global Regulatory and cGMP requirements and the ability to apply them effectively. + Strong ... problem-solving skills with a logical and analytical approach to complex challenges. + Exceptional communication skills to convey complex technical concepts to peers, department management, and cross-functional teams. + Skillful in mentoring, coaching,… more