- Merck & Co. (Rahway, NJ)
- …& Technology (DD&T) organization designs, develops, and commercializes novel biologic/ drug / vaccine - device enabled combination products to achieve safe and ... and development, manufacturing process development, qualification, validation, and design control and risk management techniques to positively support and influence… more
- Tris Pharma (Monmouth Junction, NJ)
- …in liaison with Product Development (PD)/Quality Assurance (QA)/Quality Control (QC)/Regulatory Affairs, including reviews/approvals of Change Control ... well as test methods and proceduresPrepares CCRs, according to change control processCoordinates, advances and monitors progress for all required documentations and… more
- Insmed Incorporated (San Diego, CA)
- …project and business strategies.Facilitate collaboration with both internal and external drug substance analytical, quality control , quality assurance, and ... manufacturing teams.Exercise judgment in selecting methods, techniques and evaluation criteria to obtain high quality results on time and on budget.Update group members on background and status of projects by giving oral updates or internal… more
- Merck & Co. (Rahway, NJ)
- …Our Team as an Associate Principal Scientist/Associate Director in Biologics Drug Substance Commercialization!Are you ready to make a significant impact in ... forefront of innovation in the-Manufacturing Division, specifically within the-Biologics Drug Substance Commercialization (BDSC) team. Our Downstream Purification-department is… more
- Merck & Co. (Rahway, NJ)
- …(FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply ... GMP standard operating procedures and protocols in support of sterile clinical drug product operations. This individual will leverage leadership skills in strategic… more
- Merck & Co. (Durham, NC)
- …North Carolina. This new facility will include end-to-end processing of both drug substance and drug product, including product inspection, warehouse, utilities, ... and quality control laboratories.The Specialist, Operations will be responsible for providing...transfer for a new facility in Durham, NC within Drug Substance, Drug Product and/or supporting areas.Support… more
- Merck & Co. (Rahway, NJ)
- …Development & Technology (DD&T) Team designs, develops, and commercializes novel biologic/ drug /vaccine - device enabled combination products to achieve safe and ... be expected to apply his/her knowledge of product development and design control principles to positively support and influence clinical and commercial combination… more
- Merck & Co. (Rahway, NJ)
- …and combination products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead a team of engineers and ... late stages of development, and working collaboratively with receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality.Provide… more
- Merck & Co. (Rahway, NJ)
- …Clinical Research, Cross-Functional Team Leadership, Data Analysis, Detail-Oriented, Drug Development, Good Manufacturing Practices (GMP), Inventory Control ... the timelines for bulk manufacturing needs and release of drug product across assigned program(s) . - Works directly...s used within the assigned program(s) ( ie Bulk Drug Product).- - Oversees all bulk drug … more
- Merck & Co. (South San Francisco, CA)
- …you passionate about leveraging cutting-edge AI/ML technologies to revolutionize drug discovery and development? The Pharmacokinetics, Dynamics, Metabolism, and ... AI/ML to support efforts in transforming the way PDMB leads the assessment of drug candidates. The successful candidate will join a dynamic Data Science team focused… more
- Merck & Co. (Rahway, NJ)
- …expertise to optimize and fully characterize the enzyme manufacturing process control strategy across different scales.The successful candidate will play a pivotal ... development including performing unit operations common in small molecule drug substance process development such as chemical reactions, work-up, and… more
- Formation Bio (New York, NY)
- …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
- 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)
- …establish a consolidated , visible forecast for all study product needs (Bulk Drug Product and Clinical Finished Goods).- - Responsible for authoring clinical supply ... - Knowledge of order management, supply chain operations and document control - #MSJR #eligibleforERP GCSCareer25 #VETJOBS #GCSCareer Current Employees apply HERE… more
- Merck & Co. (San Diego, CA)
- …and execute computational studies to elucidate molecular mechanisms of drug action (MoA), disease pathogenesis, and therapeutic response, leveraging multi-modal ... analysis strategies, and interpret results in the context of drug discovery and development in immunology.Effectively communicate complex computational findings… more
- Insmed Incorporated (San Diego, CA)
- …Development Team representative as an Analytical Lead for a drug program.Key Responsibilities:Responsibilities include developing and optimizing analytical methods ... various spectroscopic equipment. This involves assessing properties of AAV drug candidates and troubleshooting technical issues. Contributes to method qualification… more
- Aequor (Thousand Oaks, CA)
- …strive to serve every patient, every time. In this critical role for the Thousand Oaks Drug Product (DP) facility, - also known as ATO B20 - you will be responsible ... and/or indirect people management / leadership experience Understanding of Drug Product Formulation and Vial/Syringe Filling operations Experience with various… more
- Merck & Co. (Rahway, NJ)
- …advice to stakeholders creating optimal development, commercialization, and drug /delivery device supply strategies-Building our leadership and functional capability ... regulatory activities with cross- product or cross-functional impact, including drug device/combination products and software as medical device platforms.- Reviews… more
- Tris Pharma (Monmouth Junction, NJ)
- …the organization. Ensures compliance with all current GxPs, Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and Occupational ... receiving, storage and distribution of materials and products; Implements inventory control systems to maintain optimal stock levels and minimize obsolescence;… more
- Merck & Co. (Rahway, NJ)
- …strategies related to upstream processing and recombinant expression of drug candidates in early- and late-stage development.Responsibilities include, but are ... in media/solution development and chemistryHigh-throughput experimentation, automation, and process control .Knowledge of microbial fermentationCell culture predictive modeling (omics (transcriptomics,… more
