- Merck & Co. (Rahway, NJ)
- …supporting excipients, package component, medical device component, and combination product release testing across the entirety of our non-sterile and sterile ... Leading a team of specialists and scientist supporting raw material release and medical device & combination product testingEnsuring on-time release… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …responsible for performing a wide range of activities to support the Manufacturing and release of CAR-T drug product for human use. This position is responsible for ... Standard Operating Procedures (SOPs) in relation to the batch review/ release process.Contribute to process improvement.Ensure turnaround times are adhered to during… more
- Merck & Co. (Rahway, NJ)
- …of the position is to oversee GMP environmental monitoring and microbiological release of pipeline products.- The director will provide guidance, lead activities, ... a team of microbiologists whose roles include executing analytical methods to release clinical drug substance and drug product and support both non-sterile and… more
- Merck & Co. (Millsboro, DE)
- …batch record review, completes quality checks and SAP transactions required to release product. The role performs process document audits for accuracy and ... Batch Record Review, Drug Product Manufacturing, Pharmaceutical Manufacturing, Product Release , Quality Mindset, Regulatory Compliance, USDA Regulations, Vendor AuditsPreferred… more
- Eisai, Inc (Exton, PA)
- …will be expected to provide guidance to methods development, supervise release and stability testing activities; direct product characterization and assay ... will be expected to provide guidance to methods development, supervise release and stability testing activities; direct product characterization and assay… more
- Merck & Co. (Rahway, NJ)
- …and design transfers for testing readiness, which includes incoming and release tests for components and combination products. This position also supports ... final assembly process validation, shipping studies, etc.Support establishment of incoming and release tests at the component and combination product level with key… more
- AUROBINDO (Durham, NC)
- …IPQA, Quality Control, Production and Supply Chain to meet finished product release goals. Be able to perform all IPQA (In-Process Quality Assurance) functions ... on the floor.Assist in batch review.Coordinate printed packaging material release .Coordinate annual CV program.Assist in APR entry/ approval.Review and approve… more
- Cipla (Fall River, MA)
- …formulations as per schedule to meet OTIF Follow-up with QA for timely release and arrange vehicles for scheduled dispatch Plan the distribution of materials as ... follow-up on delivery time (Daily) Productionfor dispensing (Daily) QC, QAfor release (Daily) Engineeringfor breakdown (Need Basis) HSEfor safety norms (Daily)… more
- Merck & Co. (Rahway, NJ)
- …coordinated marketing and customer success activitiesGo-to-Market & Commercialization Drive release planning, launch execution and ongoing product support with ... cross-functional partnersCoordinate with supply chain and manufacturing as needed to bring products to market efficientlyEstablish customer success frameworks and support models to maximize adoption and satisfactionPerformance & Accountability Own financial… more
- Merck & Co. (Rahway, NJ)
- …vendors), ensuring disciplined program governance and predictable delivery. Drive release planning, deployment, user acceptance, and adoption across plants; partner ... with change management to embed new ways of working with operators and supervisors. Define, measure and report product KPIs and benefits realization (eg, OEE, lead time, yield, scrap rates, order-to-ship lead time, TCO), iterating until outcomes are achieved.… more
- Aequor (Fort Worth, TX)
- …control limits, and make recommendations on appropriateness of data for release . Identify quality problems and recommend solutions. Evaluate analytical methods and ... procedures to determine how they might be improved. Complete documentation needed to support testing procedures including data capture forms, equipment logbooks, or inventory forms. Calibrate, validate, or maintain laboratory equipment. Compile laboratory test… more
- Aequor (Fort Worth, TX)
- …them to specifications, and make recommendations on data suitability for release . Identify biological quality problems and recommend solutions. Evaluate biological ... testing methods and procedures for potential improvements. Complete documentation needed to support biological testing procedures, including data capture forms and equipment logbooks. Calibrate, validate, or maintain biological lab equipment. Compile… 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
- Merck & Co. (North Wales, PA)
- …to scrum masters, technical lead(s) and development team in release planning to manage high-quality product delivery leveraging Agile/DigitalSDLC ... methodologyCollaborate with engineering and design to ensure work is well refined, scoped and ready for delivery; accept user stories before they enter sprints.Act as product owner through delivery to ensure outcomes are met and scope aligns with the product… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …MSAT and/or Quality/Compliance (particularly in material/ raw material enrollment and release ).Experience in a cross functional commercial team in driving global ... programs and/or initiatives.Experience in developing, writing and approving technical documents.Experience with Quality systems (Change control, investigations, LIMs, etc.).Extensive technical writing experience.Knowledge in cell therapy validation industry… 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 products 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 within… more
- Merck & Co. (Rahway, NJ)
- …setup and cleaning and raw material inventory management activities. Support API release , and initiate, track and/or execute shipment of GMP materials. Foster a ... culture of collaboration, learning, and innovation. Serve as a technical mentor and help train rotational and new employees. Supervise staff performing GMP activities and deliver training as needed. Support deviation investigations, corrective/preventative… more
- Insmed Incorporated (NJ)
- …initiatives across development programs.Responsible for final product Quality release /rejection and related processes.Support supplier and internal audits as ... Standard Operating Procedures relating to areas of responsibility including product release , design control, etcAdditional duties as assignedWho You Are:BS degree in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …strong, compliant CQV program to enable robust production, testing and release of product to patients.Key Responsibilities Executes the commissioning, qualification, ... requalification, validation and any associated maintenance activities within the plantManages multiple and complex CQV projects, provides status reports and coordinates with other departments or outside contractors/vendors to complete tasksSupports and/or owns… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …regulatory compliance, team readiness, and processing of product prior to release to patients.Schedule: Mon-Fri, 2nd ShiftKey Responsibilities Leads, coaches and ... delivers a holistic, effective process qualification program for Operations trainees who support daily clinical production and strategically prepare for commercial supply of a CAR-T productManages, plans, coordinates, prepares and performs hands-on process… more
