- Merck & Co. (Rahway, NJ)
- …manufacturing sites, clinical safety and risk management to uphold the highest quality standards and drive innovation in product stewardship.- As a key senior member ... organizations, and external partners to stay abreast of relevant regulations, standards , and best practices, and to represent the company's technical product… more
- Tris Pharma (Monmouth Junction, NJ)
- …Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs) and Food and Drug Administration (FDA) standards . Performs routine and complex work ... related to the troubleshooting, repair, and upgrade of manufacturing equipment; Responsible for the preventive maintenance (PM), repair and continuous improvement of facilities and manufacturing equipment Assists in performing root cause analysis on equipment… more
- Aequor (Chattanooga, TN)
- …Procedures (SOP's), Good Manufacturing Practices (GMP) Compliance, and Food and Drug Administration (FDA) regulatory standards . Maintain compliance with all ... designs for new products, line extensions, and packaging operations. Develop standards for equipment, systems, and engineering processes for assigned functional area… more
- Merck & Co. (Rahway, NJ)
- …In summary, our team enables the translation of preclinical candidates into non-oral drug products.We are seeking a highly motivated candidate for a strong candidate ... of Principal Scientist (R5) within the team focused on developing parenteral drug products of small molecule and/or intermediate modalities. The successful candidate… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsible for performing a wide range of activities to support the release of drug products for human use. This position is responsible for quality and maintaining ... the highest standards in compliance within company policies, procedures, and all...all applicable regulations.Key Responsibilities Manage the team responsible for drug product batch record review and drug … more
- Merck & Co. (Rahway, NJ)
- …to deliver innovative solutions to patients and customers around the worldValues and Standards - Our Steadfast Commitment to Our Values and Standards will ... development in any modality (eg small molecules, large molecules, vaccines, drug substance or drug product, etc.) or chemical development in a related industry,… more
- Merck & Co. (Rahway, NJ)
- …& Process Development (DPPD) Team designs, develops, and commercializes novel biologic/ drug /vaccine - device enabled combination products to achieve safe and ... set direction for the device development strategy for multiple drug -device combination product development programs ranging from concept generation/selection,… more
- Genmab (NJ)
- …scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation ... related work is performed in accordance with Genmab SOP/processes and standards and ICH-GCPCTT member:Participate and represent BiostatisticsReview and provide input… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …sets project requirements, evaluates compliance with project and engineering standards , and approves final designs and installations. Identifies, investigates, and ... are consistent with contract specifications and all relevant regulations and engineering standards . Supports the review of equipment, building, and other job plans… more
- Merck & Co. (Rahway, NJ)
- …focus on front-end development, emphasizing the exploration and assessment of emerging drug delivery device technologies. The ideal candidate will lead efforts in ... more efficiently in our Company's early portfolio.Key Responsibilities:Evaluate cutting-edge drug delivery device technologies and their potential applications to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... activities; collaborates closely with data manager to ensure high quality data.- Drug Development Strategy: Provides input to multiple aspects of the development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... to ensure high quality coding deliverables are on time to support drug development processes and global submissions. This position also partners with internal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... Assist Leadership to ensure compliance with protocol and internal/external standards . Identifies and drives strategy for process improvement initiatives. Reviews… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... create and modify Structured Product Labeling for FDA submission, complete electronic drug listing, track and archive affiliate labeling for global products and… more
- Merck & Co. (Rahway, NJ)
- …position will be responsible for technical interrogation of the various drug delivery device technology platforms supporting our pipeline to identify risks ... as the opportunities arise, develop new and novel delivery technologies.These drug delivery device technology platforms are often assemblages of glass pre-filled… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... Management and maintains oversight of PV relevant contracts. Oversee and set standards for PV contract management. Review contribute to revision of DSI contracts… more
- Merck & Co. (North Wales, PA)
- …health. This position supports statistical programming activities for late stage drug /vaccine clinical development projects. This may include leadership of one or ... and report programming development and validation utilizing global and TA standards and following departmental SOPs and good programming practices.Maintain and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …local, state and federal regulations including and equivalent to Federal Drug Administration (FDA), Environmental Protection Agency (EPA), Occupational Safety and ... Health Administration (OSHA), and Drug Enforcement Agency (DEA) as applicable (TSA) Transportation Security AdministrationAbility to work hours from approximately… more
