- Merck & Co. (Rahway, NJ)
- …(TT), scale-down model qualification (SDMQ) and process characterization (PC).Experience authoring technical documentation in support of the following: process ... the Cell Culture and Fermentation Sciences (CCFS) department provides the technical process leadership and laboratory capabilities in support of late-stage pipeline… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a dynamic and experienced IT Infrastructure Lead to join our Capital Projects IT Infrastructure team.- Our team is dedicated to the ... and substantial renovations of existing ones.As an IT Infrastructure Lead , you will have a unique opportunity to leverage...you will have a unique opportunity to leverage your technical knowledge and experience in a role centered on… more
- Merck & Co. (Rahway, NJ)
- …to the product roadmap, ensuring alignment with future releases and technical capabilities. Lead project activities including business process analysis, scope ... our company. This product analyst position requires a blend of analytical, technical , and business skills to effectively engage with cross-functional teams and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …analytics, testing, and integration, to ensure cohesive and comprehensive service delivery. The lead will provide technical leadership, guiding the team in the ... creation of business cases and the preparation of Kessai and/or Project Entrustment documentation for budget approvals. The Lead will also manage vendor… more
- Merck & Co. (Rahway, NJ)
- …product to ensure completion of key milestones and laboratory / regulatory documentation . Active strategic and technical leadership on program development teams, ... collaborate in a fast-paced multidisciplinary team environment. Primary Duties: Lead /contribute towards the new, innovative approaches for small molecule,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …operations and technical support of the relevant HRIS Module(s) including technical process and annual cycle management, documentation , testing, training and ... Compensation, Variable Pay. This role will serve as Global Technical Owner for the relevant area.ResponsibilitiesResponsible for the design, configuration,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …test Plans (CTP), Installation/Operational Qualification (IOQ).Define standardizations and update documentation (eg SOPs, WIs, Technical & Design Specifications, ... be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at the… more
- Merck & Co. (Rahway, NJ)
- …DescriptionJob Description Are you enthusiastic and driven to create and lead execution of design verification testing strategies for innovative combination ... including inhalation, implantation, and injection.The Associate Principal Scientist will lead the definition and execution of design verification strategies, and… more
- Merck & Co. (Rahway, NJ)
- …medical breakthroughs. We are looking for a collaborative, self-motivated -scientific leader with expertise in downstream bioprocessing to join Biologics Process ... development.Responsibilities include, but are not limited to:Serve as a scientific leader to shape and drive innovation across the Biologics pipeline, strategy,… more
- Merck & Co. (Rahway, NJ)
- …ensure that customer/stakeholder needs are the cornerstone of decisions and expectations- Lead technical investigations of medical device and combination product ... device, complex combination product kits, prefilled syringes, autoinjectors, and related scientific/ technical concepts and techniques are a must for this position.… more
- Merck & Co. (Rahway, NJ)
- …customers both internal and external to GCS and serve s as the lead GCS spokesperson at clinical and development related meetings.- Working independently, the ... Interacts closely with key partner organizations ( as a lead GCS Planning program representative ) such as clinical...Development Teams . - Responsible for authoring clinical supply documentation in support of labeling and packaging activities as… more
- Aequor (New Brunswick, NJ)
- …with IT vendor lead to translate BRD into URS, FRS, and Technical Specs and obtain designSupport functional leads in validation testing documentation , system ... and stay within funding estimates.Prepare all project status reports and documentation to keep sponsors informed of progress and potential risks/roadblocks.Actively… more
- Merck & Co. (Rahway, NJ)
- …SM PR&D pipeline. Responsibilities: Under the scientific direction of a facility lead , the Operations Specialist will participate in equipment setups, raw material ... of the facility.Ensure facility readiness with respect to cleaning (including documentation and execution), dummy run and batch execution, building housekeeping, and… more
- Merck & Co. (Rahway, NJ)
- …needs. This individual will play a critical role in enhancing internal technical capabilities by mentoring junior staff and advancing the functionalities of our ... participating in risk assessments, investigating deviations, and following Good Documentation Practices (GDPs).A high level of innovation, creativity, and… more
- Tris Pharma (Monmouth Junction, NJ)
- …Process Improvements (CPIs), Product Quality Complaints (PQC) documentation , compliance efforts, quality operations, etc. Responsibilities:Assures compliance ... company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior Leadership, etc.) on deviations and PQC investigations… more
- Merck & Co. (Rahway, NJ)
- …and documentation to meet program deadlines.Authoring and reviewing internal technical reports, sections of regulatory filings (eg, IND, BLA) and external ... the group Director to define group strategy and to lead a team of scientists in solving complex analytical...collaboration is expected. Experience in leading small groups of technical personnel, leading projects, and defining group or departmental… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Management Data Operations team and serves both as a subject matter expert and leader of a group responsible for the business administration of the CDR/AP system(s) ... review of user access and audit trail reconciliation, impact analysis and documentation of identified access discrepancies per study to maintain overall compliance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Experience AI/ML-based solutions and programs is highly desirable Ability to lead without authority/reporting relationship required Analytical and/or technical ... a fast-paced, environment, with a quality control focus and a documentation orientation Creative problem-solving with ability to solve complex unstructured problems;… more
- World Insurance Associates, LLC. (Iselin, NJ)
- …of our multiple offices throughout the region. Position Overview The IT Acquisition Technical Lead will provide strategic technical leadership for Mergers ... people skills, leading and participating in a team environment. + Strong technical documentation skills. + Applicants must be organized and able to communicate… more
- PSEG (South Plainfield, NJ)
- …and construction personnel. + Coordinate with vendors and manufacturers in reviewing technical documentation including vendor drawings. + Be an active ... through progressive experience and education. This position requires a strong technical background in protection & controls engineering for substations to develop… more
