- Aequor (Thousand Oaks, CA)
- …key functions that enable the B20 plant to add value to the network: Manufacturing , Process Development, Supply Chain, Quality , and Facilities & Engineering. A ... Lessons Learned and presentation to management when appropriate. Reviewing protocols for manufacturing activities and partnering with Quality Assurance to ensure… more
- Merck & Co. (Durham, NC)
- …: Our Company is seeking a dynamic and versatile leader for External Manufacturing Operations, Drug Delivery Systems and Devices within our Manufacturing ... (8) years of experience in Biopharmaceutical industry across multiple manufacturing disciplines (Operations, Quality , Technology, Engineering, Supply Chain,… more
- Merck & Co. (Rahway, NJ)
- …Decision Making, Detail-Oriented, Maintenance Supervision, Manufacturing Process Validation, Manufacturing Quality Control , Manufacturing Scale-Up, ... in cell culture commercialization. The primary objective of the Biologics Drug Substance Commercialization (BDSC), Cell Culture Sciences department is to provide… more
- Merck & Co. (Rahway, NJ)
- …draw on their expertise to optimize and fully characterize the enzyme manufacturing process control strategy across different scales.The successful candidate ... quality compliance, which will include following current Good Manufacturing Practices (cGMPs), and participating in risk assessments, deviation investigations,… more
- Merck & Co. (Durham, NC)
- …Relationships, Inventory Management, Management Process, Manufacturing Processes, Manufacturing Quality Control , Operational Excellence, People ... position is in direct support of our Upstream Fermentation manufacturing process for Bulk Drug Substance. Focused...Regulatory Agency, and State and Local code requirements for quality , good manufacturing practices (GMP), equal employment… more
- Merck & Co. (Rahway, NJ)
- …sites, drug product partners, and Technical Product Leaders, regulatory and quality .Provide Voice of Manufacturing input to early development teams to ensure ... and combination products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead a team of engineers and… more
- Merck & Co. (Rahway, NJ)
- … Environments, Mechanical Apptitude, Pharmaceutical Development, Pharmaceutical Manufacturing , Pharmaceutical Quality Assurance, Process Technologies, ... Job DescriptionThe Small-Scale Organics (SSO) Pilot Plant is a GMP (Good Manufacturing Practices) manufacturing facility in the Small Molecule Process Research… more
- Merck & Co. (Rahway, NJ)
- …Team Leadership, Data Analysis, Detail-Oriented, Drug Development, Good Manufacturing Practices (GMP), Inventory Control System, Inventory Management, ... ( s ) . - Responsible and accountable for establishing the timelines for bulk manufacturing needs and release of drug product across assigned program(s) . -… more
- Merck & Co. (Rahway, NJ)
- …Drug Product Development, Estimation and Planning, GMP Compliance, Management Process, Manufacturing Quality Control , Medical Supply Management, Medicinal ... (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical… more
- Merck & Co. (Rahway, NJ)
- … Manufacturing , Mechanical Apptitude, Pharmaceutical Development, Pharmaceutical Manufacturing , Pharmaceutical Quality Assurance, Process Technologies, ... Scale Organics (SSO) Pilot Plant is a GMP (Good Manufacturing Practices) manufacturing facility in the Small...supplying Active Pharmaceutical Ingredient (API) for clinical use and drug product development. This will involve handling of a… 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, ... support the installation, operation, maintenance and/or troubleshooting of biopharmaceutical manufacturing equipment such as washers, autoclaves, tanks, bioreactors, filtration… 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 ... clinical supply needs per study and providing the signal for sourcing, manufacturing , packaging, and distribution- for our company development products and non-our… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of multiple myeloma.Legend Biotech is seeking MES Engineer as part of the Manufacturing Excellence team based in Raritan, NJ. Role OverviewThe MES Engineer will be ... part of Manufacturing Excellence team reporting to the Manufacturing ...Global Procedures.Act as a Site MES SME to support Quality Investigations, Corrections, and QMS records.Build the Site Readiness… more
- Insmed Incorporated (San Diego, CA)
- …with both internal and external drug substance analytical, quality control , quality assurance, and manufacturing teams.Exercise judgment in selecting ... from purification development and optimization, process characterization and clinical manufacturing investigation support. As part of this collaborative group, your… 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 ... team focused on bringing AI/ML approaches to bear to improve the speed and quality of decision-making in drug discovery and development. PDMB aims to leverage… more
- Tris Pharma (Monmouth Junction, NJ)
- …for multiple facets of the Procurement function within a pharmaceutical manufacturing environment including, but not limited to, purchasing, sourcing, logistics, ... the organization. Ensures compliance with all current GxPs, Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and Occupational… 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
- 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
- SourcePro Search, LLC (Northvale, NJ)
- We are seeking a Quality Assurance Assistant with a Bachelor's Degree in Quality Assurance, Food Science, Biology, Microbiology, Operations Management, or a ... candidate will have experience in USDA and FDA food manufacturing , and be bilingual in English and Spanish. The..., and be bilingual in English and Spanish. The Quality Assurance Assistant is responsible for ensuring that food… more
- BioSpace (Lebanon, IN)
- …process. Key Objectives/Deliverables Understand the scientific principles required for manufacturing intermediates, bulk drug substances and drug ... Therapy. At Lebanon, Indiana, this facility will be Lilly's most technically advanced manufacturing site focused on the delivery of the next wave of innovative… more
