- Merck & Co. (Rahway, NJ)
- …Making, Detail-Oriented, Maintenance Supervision, Manufacturing Process Validation, Manufacturing Quality Control , Manufacturing Scale-Up, People Management, ... in cell culture commercialization. The primary objective of the Biologics Drug Substance Commercialization (BDSC), Cell Culture Sciences department is to provide… more
- Insmed Incorporated (San Diego, CA)
- …and guide project and business strategies.Facilitate collaboration with both internal and external drug substance analytical, quality control , quality ... judgment in selecting methods, techniques and evaluation criteria to obtain high quality results on time and on budget.Update group members on background and… more
- Merck & Co. (Rahway, NJ)
- …Development, Estimation and Planning, GMP Compliance, Management Process, Manufacturing Quality Control , Medical Supply Management, Medicinal Chemistry, ... (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply… 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 ... launch in alignment with the company's business goals, and quality and regulatory compliance.-Essential Duties and Responsibilities:Strategic Leadership and Project… more
- Merck & Co. (Rahway, NJ)
- …Clinical Research, Cross-Functional Team Leadership, Data Analysis, Detail-Oriented, Drug Development, Good Manufacturing Practices (GMP), Inventory Control ... a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines ,- strategies and… more
- Merck & Co. (South San Francisco, CA)
- …developing, implementing, and optimizing GenAI approaches to streamline the creation and quality control (QC) of regulatory submission documents. The candidate ... bringing AI/ML approaches to bear to improve the speed and quality of decision-making in drug discovery and development. PDMB aims to leverage Generative AI… 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 ... -The candidate will provide scientific expertise by learning and utilizing Quality Risk Management methodologies and tools for statistical design of experiments.… more
- Merck & Co. (Durham, NC)
- …Relationships, Inventory Management, Management Process, Manufacturing Processes, Manufacturing Quality Control , Operational Excellence, People Management, ... 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… more
- Merck & Co. (Durham, NC)
- …Durham, North Carolina. The new facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, ... validation testing support, supporting root cause investigations and change control activities. Actively supports, participates and embraces an inclusive team… more
- Aequor (Thousand Oaks, CA)
- … Product Formulation and Vial/Syringe Filling operations Experience with various quality systems including change control , deviations, corrective and ... time. In this critical role for the Thousand Oaks Drug Product (DP) facility, - also known as ATO...value to the network: Manufacturing, Process Development, Supply Chain, Quality , and Facilities & Engineering. A high degree of… more
- Eisai, Inc (Exton, PA)
- …will collaborate effectively with other Development groups as well as with Facilities, Quality Assurance, Quality Control , Regulatory, and CMC Program ... Interact cross-functionally with Support Services, Facilities, Biologics Process Development, Quality Assurance, Quality Control , Validation, 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
- Merck & Co. (Rahway, NJ)
- …. - Interacts with key partner organizations such as clinical development, regulatory, quality and other supply chain areas to address clinical supply related topics ... establish a consolidated , visible forecast for all study product needs (Bulk Drug Product and Clinical Finished Goods).- - Responsible for authoring clinical supply… more
- Insmed Incorporated (San Diego, CA)
- …for trend analysis are also key duties. Collaboration with R&D, Process Development, Quality Control , and Regulatory Affairs is essential, as is facilitating ... Development Team representative as an Analytical Lead for a drug program.Key Responsibilities:Responsibilities include developing and optimizing analytical methods… more
- Merck & Co. (Rahway, NJ)
- …on regulatory obligations, compliance requirements and company strategy.Providing quality advice to stakeholders creating optimal development, commercialization, and ... drug /delivery device supply strategies-Building our leadership and functional capability...Women's Health programs. Prioritizes and oversees execution of high quality and timely health authority engagement in attaining desired… 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 ... across organization to ensure continuity of supply while optimizing cost, quality and delivery for internal and external stakeholder satisfactionCollaborates cross… 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 ... Biologic, and Vaccine Products. Our team works with a "Safety First, Quality Always" mindset.-As the primary point of contact for all dealings between… more
- Merck & Co. (Rahway, NJ)
- …development, and supplying Active Pharmaceutical Ingredient (API) for clinical use and drug product development. This will involve handling of a variety of reagents, ... closure.As needed, safely perform High Risk Work involving hazardous energy control .Identify and follow through on opportunities to improve building flexibility,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …with alignment to Global Procedures.Act as a Site MES SME to support Quality Investigations, Corrections, and QMS records.Build the Site Readiness of MES for FDA ... cGMP manufacturing and project planning experience preferred.Provide technical expertise of Change Control process as well as oversight of the MES team to ensure… more
- Merck & Co. (Rahway, NJ)
- …development, and supplying Active Pharmaceutical Ingredient (API) for clinical use and drug product development. This will involve handling of a variety of reagents, ... - As needed, safely perform High Risk Work involving hazardous energy control . - Identify and follow through on opportunities to improve building flexibility,… more
