- Legend Biotech USA, Inc. (Raritan, NJ)
- …position is responsible for performing a wide range of activities to support the release of CAR-T drug product for human use. This position is responsible for ... for QA oversight of final CAR-T product batch record review and release practices.Lead the establishment and improvement of QA practices to ensure accurate… more
- Merck & Co. (Rahway, NJ)
- …or Manufacturing O rganizations . - Facilitate manufacturing, packaging , and release of clinical supplies for clinical studies, assist in scale up activities ... technologies, including: continuous manufacturing, t hree d imensional (3D) printing, controlled release , and/or oral delivery of large molecules. - Experience with… 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. (Millsboro, DE)
- …life-changing animal vaccines. Your leadership will shape manufacturing systems and release processes that enable reliable, efficient vaccine production at scale. If ... and scientific problem solving.Provide subject matter expertise for product release , aseptic operations, formulation and fill/finish activities.Ensure compliance with… more
- 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
- Merck & Co. (Rahway, NJ)
- …proven performance recordKnowledge with drug substance and drug product release , stability, and extended characterization testing for vaccines and biologicsStrong ... organizational and project management skillsAbility to effectively identify and express risks Preferred Deviation management and change control processesAuthoring and/or reviewing technical documents to support Process Performance Qualification (PPQ)Global… more
- Merck & Co. (Durham, NC)
- …labels on the shop floor.- Assist with label preparation (eg, GLIMS, Release ) for upcoming productionExecutes operation sample management of samples handled within ... DurhamReview special communications at shift change to include 4-Quad.Executes room incursion initiation and approvals Assists Manager in leading a team-based culture through continuous improvement activities- Assist Manager with facilitating shift change.-… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to ensure sterility of the product/process is not compromised.Support material release in SAP for In-house reagents.Strive to reduce non-conformances in supported ... areas by proactively driving compliance.Support Investigations team by providing quality and compliance input for continuous improvement and remediations.Serve as a backup for approving printed labels and documents prior to use on the manufacturing… more
- Merck & Co. (Rahway, NJ)
- …Projects may include solid oral dosage forms (tablets, capsules, modified release formulations), biologics, vaccines, or specialty dosage forms inclusive of ... drug-device combinations.- Therefore, sufficient knowledge in the above areas is critical.- Additionally, they are expected to drive one of several focus areas within the team.- Including but not limited to; vendor network strategy, vendor relations, shipping… more
- Merck & Co. (Rahway, NJ)
- …combination products.Provide support for the external partner component manufacturing, release and distribution to global manufacturing sites.Identifying issues with ... minimal signals, problem solving, identification of root cause provide solutions.Build and enhance device or combination product technology transfer programs in both development and lifecycle management, ensuring compliance with relevant regulatory… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …runs with the site cross-functional team.Support and coordinate raw material release status, PO status, and documents to ensure on-time production schedule ... execution.Develop and maintain functional stakeholder relationships to assemble and execute an optimized, aligned schedule.Monitor day processing activities against the scheduling plan and address ERP issues related to Sales Orders, Process Orders, and Code… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …issues resulting in the delay of investigation closure and product release .Support regulatory inspections and audits by ensuring inspection readiness within facility ... and serving as an SME during the execution of regulatory inspections and audits as needed.Support compliance activities for site Quality Operations in accordance with Legend standards, procedures and cGMPs.Collaborate with site personnel to provide guidance… more
- Aequor (Kalamazoo, MI)
- …team laboratory environment to analyze finished product samples prior to commercial release . This is a dynamic, growing lab within a growing manufacturing site ... with opportunity to learn new skills and to work cross-functionally.Responsibilities: Performs, documents and record checks qualitative and quantitative assays on samples. The primary technologies in this lab are HPLC and dissolution. Interprets and evaluates… more
- Aequor (East Syracuse, NY)
- …microbiological laboratory testing of raw materials and products for in-process, release and stability samples in compliance with methods, procedures, protocols and ... regulatory requirements. The QC Microbiology Laboratory technician performs lab analysis of environmental and utility samples and identification of microorganisms according to defined procedures.Duties/Responsibilities (most critical… 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 $80,000.00/Yr. MaxUSD $90,000.00/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)
- …eBR development, modeling, and deployment in MESParticipate in design testing, release planning, and demos with partners.Support MES updates with other Supply ... Chain Systems (ERP, eLIMs, etc.).Support MES validation activities according to the Software Development Lifecycle (eg commissioning test Plans (CTP), Installation/Operational Qualification (IOQ).Support updates to standardizations and documentation (eg SOPs,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …limited to CRF/eCRF design, all steps from database development to database release , data review and cleaning, database lock), to ensure data quality/integrity and ... regulatory compliance- Ensures that Data Management Plans are consistent and regulatory compliant across studies and programs.- Promotes Risk Based approaches to data cleaning and review- Proactively collaborates cross-functionally during interactions with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …across relevant cross functional groups to enable robust production, testing and release of product to patients. This individual will be an integral part ... of the CAR-T Equipment team in support of on-going clinical and commercial manufacturing as well as facility expansions and improvements.Key Responsibilities As a Facility Engineer you are responsible for the technical support of all equipment and process… more
- Merck & Co. (Rahway, NJ)
- …Ability to design, execute and/or direct the development and qualification of release , characterization, and stability assays for testing of clinical trial material ... and in support of product and process development - A strong team player with excellent oral and written communication skills; ability to work both independently for development of assays and cross-functionally for successful transfer of assays. Plan assay… 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
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