- Tris Pharma (Monmouth Junction, NJ)
- …Scientist I, under minimal guidance, performs analytical method validations and release /stability raw materials, in process (IP), finished products (FP) and ... state, federal and local laws Performs validation of analytical methods and release /stability testing for raw materials, IP, FP and ST samples of… more
- BioAgilytix (San Diego, CA)
- …lead scientific and operational activities in support of preclinical, clinical, and product release studies for our San Diego lab. This role requires deep expertise ... validating bioanalytical assays for support of preclinical, clinical and product release studies.Motivating team by inspiring employees to achieve goals and aligning… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …collaboration across relevant cross functional groups to ensure robust production, testing and release of product to patients.Serve as the delegate for the Head of ... Operations.Establish key stakeholder relationships with internal and external stakeholders. Ability to interact with all levels within the organization.RequirementsBachelor's degree in Engineering, Life Sciences, or related field (required).Advanced degree… more
- Merck & Co. (Rahway, NJ)
- …as applicable, for the System Specific Global User Group Forums, Release /System Communication authoring and Program Updates, as requested.Preferred Experience and ... Skills:Candidate must be familiar with IT system and business process support, preferably in the Regulatory or Labeling Management space with general understanding of Label Update process.Analytical and process minded with a short learning curve for systems… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …but not limited to cytotoxicity assay, serial cytotoxicity assay, and cytokine release assay etc.Help execute the evaluation of in-vivo CAR virus using in-vitro ... assays and in-vivo mice models.Design, execute and interpret research requiring molecular biology techniques including PCR/DDPCR/ qPCR, NGS, RNA and DNA analysis.Perform research requiring cell biology techniques including cell culture, transfection, FACS, and… more
- AUROBINDO (Durham, NC)
- …formulation for each line.Communicating with brokers for timely FDA release of materials.Measuring and reporting effectiveness of the department ... activities.Interpreting company policies to workers and enforcing safety regulations.Recommending measures to improve quality of service, increasing efficiency and performance of department.Continuous improve warehouse operations.Deviation writing as required… more
- Eisai, Inc (Raleigh, NC)
- …GMP setting (eg, batch record review, SOP writing, auditing, batch release functions, deviation investigation and resolution, as applicable) .Familiarity with ... applicable regulatory requirements (eg, FDA, EMA, ICH) and quality systems.Strong oral and written communication skills.Strong attention to detail and ability to work independently.Exercises independent judgment in evaluating product disposition.#LI - SC1#LI -… more
- Merck & Co. (Rahway, NJ)
- …Responsible and accountable for establishing the timelines for bulk manufacturing needs and release of drug product across assigned program(s) . - Works directly in ... the SAP system to establish a consolidated , visible forecast for all product s used within the assigned program(s) ( ie Bulk Drug Product).- - Oversees all bulk drug supply management and ensures proper allocation of drug product as needed across studies… more
- Aequor (Hicksville, OH)
- …lines at the beginning of the shift and at the start of batches to release lines. Monitors lines including correct weights, lot number, expiration date and scans in ... drums of product. Calculates and documents in Filling Instructions tare weights for each packaging component number. Reviews batch paperwork for accuracy and issues to the batch records clerk. Checks and prepares paperwork for upcoming batches. Sets up and… more
- AUROBINDO (Dayton, OH)
- …DEA controlled drug substances and relevant regulations.Experience in developing controlled- release product using Fluid Bed Processor (Wurster coating) technology. ... CompensationMinUSD $70,000.00/Yr. MaxUSD $80,000.00/Yr. BenefitsAnnual bonus Medical and Rx Benefits choice of four medical plans through Horizon. Rx automatically provided with medical benefits Dental Benefits with three dental plan options through CIGNA… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …across relevant cross functional groups to enable robust production, testing and release of product to patients.Key Responsibilities Leads, coaches and delivers a ... holistic, effective training program for Operations (Manufacturing, Warehouse, Facilities & Engineering, Validation, Technical Support, Supply Chain) that supports daily clinical production and strategically prepares for commercial supply of a CAR-T… more
- Repligen (Hopkinton, IA)
- …and quality-specific documentation as assigned for purposes of the release of production assemblies.QualificationsBachelor's degree in Biological Science or other ... science related disciplineMinimum 1-2 years' experience in Document Control in an ISO 9001 certified Quality Management System or equivalentStrong knowledge of Microsoft Office, including Word and Excel. MS Access a plus. Ability to communicate with multiple… more
- Repligen (Waltham, MA)
- …which includes all day-to-day activities for product manufacture, test and release including deviation support, root cause analysis, customer complaint management, ... hosting customer/regulatory audits and Certificate of Quality generation at an ISO 9001:2015 certified manufacturing site. We are an innovative life sciences company focused on developing and commercializing high-value bioprocessing products, technologies, and… more
- Genmab (NJ)
- …figures, and listings, by writing programs and ensuring QC before formal release , for deliverablesPerform QC on SAS-code written by other Genmab colleaguesSupport ... submissions by ensuring consistency of programming package with current electronic submission standards and guidelinesSupport optimization of programming processes, standards, and templatesRepresent programming in cross-functional team meetingsAct as a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …effort, and deliver robust, right first time EBR designs.Participate in design testing, release planning, and demos with partners.Serve as a Subject Matter Expert of ... MES for CAR-T and site initiatives requiring MES enhancements.Coordinate MES updates with other Supply Chain Systems (ERP, eLIMs, etc.).Coordinate and execute MES validation activities according to the Software Development Lifecycle (eg commissioning test… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …ability to drive effective and robust production, testing and release of product to patients.Key Responsibilities Diagnoses, troubleshoot, repair, maintain, ... all types of HVAC, refrigeration, clean room HVAC, clean steam, cryogenic storage equipment and all types of process equipment and systemsUtilizes knowledge and experience in plumbing, HVAC, Clean room HVAC, refrigeration, pipefitting, and millwright… more
- BioAgilytix (Durham, NC)
- …(LC/MS) techniques in support of preclinical, clinical, and product release studies.Design, plan, and execute experiments independently; troubleshoot assays; analyze ... and interpret data; prepare summary tables, plans, reports, and SOPs.Ensure GLP compliance throughout assay development, validation, and sample analysis activities, including prompt identification and notification of deviations and preparation of associated… more
- Tris Pharma (Monmouth Junction, NJ)
- …supply availability Leads and/or oversees Order Fulfillment Process from production release to customer delivery; Ensures timely and accurate shipment of finished ... goods to domestic and international markets; Collaborates with customer service, planning and distribution teams to meet service level agreementsOversees Warehouse operations, including receiving, storage and distribution of materials and products; Implements… more
- Merck & Co. (Rahway, NJ)
- …work in applying regulatory guidance and quality standards related to product release and safety.Current Employees apply HERE Current Contingent Workers apply HERE ... US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …relevant cross functional groups to enable robust production, testing and release of product to patients.Key Responsibilities Provides technical expertise in support ... of an effective calibration program that supports daily clinical production and strategically prepares for commercial supply of a CAR-T productPlans, coordinates, and performs timely execution of daily activities related to calibration and… more
