- Merck & Co. (Rahway, NJ)
- …cross-functional teams to develop and implement strategic launch plans, ensuring market readiness and optimizing commercial success. This role requires a blend of ... with organizational objectives and market dynamics, ensuring best-in-class execution.Market Readiness Oversight: Develop and implement robust market readiness … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …support to audits and Health Authority inspections, including readiness activities, to ensure internal/external compliance with requirements/regulations Support, ... Procedures (SOPs) Advanced knowledge and participation on internal audit/inspection readiness (ie FDA PADE inspection) Excellent interpersonal skills and ability… more
- Merck & Co. (Rahway, NJ)
- …and GMP requirements. This position is also responsible for ensuring facility readiness for batch processing and shares accountability for the building performance. ... are run within the capability constraints of the facility.Ensure facility readiness with respect to cleaning (including documentation and execution), dummy run… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …assigned GMA plan activities, in collaboration with Sr Director.- Support medical readiness activities for market launches and life cycle management for select ... indications/projects. Gains strategic and planning alignment across regions and functions and supports review of Local Country/Regional Medical Affairs activities when applicable. Provide medical support/input into commercial and market access discussions for… more
- Aequor (East Syracuse, NY)
- …audits, and customer audits through participating in inspection readiness and addressing inspectional findings.Perform routine laboratory activities including ... sample management, instrument maintenance and calibration, inventory and ordering of supplies, general housekeeping, and other related activities.Work in a diverse group environment while focusing on inclusivity and safety to produce high quality, compliant… more
- Aequor (Pearl River, LA)
- …Support daily high containment operations, maintain laboratory and equipment readiness , restock protective equipment (PPE), handling and decontaminating biohazardous ... waste. Prepare and update compliance activity reports. Coordinate maintenance with laboratory users to minimize work disruption. ORGANIZATIONAL RELATIONSHIPS High Containment Operations. BSL-3 users. ABSL-3 users. EDUCATION AND EXPERIENCE A high school diploma… more
- Merck & Co. (Rahway, NJ)
- …concept generation/selection, development, verification, and validation to launch readiness :Lead the cross-functional Combination Product Working Groups to ensure ... full integration of the device development activities with the clinical, regulatory, formulation, commercial and other key company functions.Lead the Device Engineering Sub-Teams focused on development of design requirements for the combination product and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …individual in this role will also be responsible for overseeing inspection readiness and supporting internal audits and Health Authority (HA) inspections. For any ... to the planned schedule internal audits and mock inspectionsSupport inspection readiness including maintaining access to relevant documentation / reportsSupport HA… more
- Merck & Co. (Rahway, NJ)
- …spending per approved spend plans.- Areas supported include FLEx Sterile1, with operational readiness in 4Q2025, and a secondary focus on FLEx Sterile2, currently in ... project phase via GES.- Provide support of the mechanical aspects of clinical operations, including support/initiation and gatekeeping of work orders, placing/expediting expense purchase orders, supporting budgets, asset depreciation, and coordinating… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …support and manage change controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating review meetings ... and sponsor various department projects to drive continuous improvements and efficiencies within cell therapy Technical Operations.Support organizational design updates, operations organization build, operations ramp-up of commercial and clinical… more
- Merck & Co. (Rahway, NJ)
- …external quality audits and maintain laboratory state of permanent inspection readiness Author or contribute to Standard Operating Procedures (SOP) draftingOriginate ... and own Investigations and Change Management recordsThe successful candidate must function both independently and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. Strong communications skills and eagerness to adapt and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …affairs plan activities, in collaboration with Sr. Director.- Leads medical readiness activities for market launches. This includes strategic partnerships with the ... brand team, HEOR (Health Economics and Outcomes Research), RD (Research Development), FMA (Field Medical Affairs), MIE (Medical Information and Education) and global functions as necessary to create and implement strategies that support launch. Provide medical… more
- Merck & Co. (Rahway, NJ)
- …part of the design.- Provide information and drive early alignment and readiness reviews with manufacturing partners to assess speed, complexity, and requirements ... for commercializing new products.Technical Expertise:Utilize extensive experience in design controls, device transfer, control strategies device risk management, and design verification testing to develop value-added solutions for medical devices and… more
- Merck & Co. (Rahway, NJ)
- …and regulatory certification of the facility, concluding startup and operational readiness activities.Once the facility is operational, this role will support the ... pipeline's most technically complex formulation and process development through process tech transfer, scale-up activities, quality investigations, change management, and authoring GMP standard operating procedures and protocols in support of sterile clinical… more
- Twist BioScience (South San Francisco, CA)
- …interact effectively with colleagues at all levels and external partners.A self-starter with readiness to take on new challenges, eager to develop new skills and ... adapt to evolving EH&S requirements.B.S. degree in Occupational Health and Safety, Environmental Science, Environmental Engineering, or an equivalent field; or equivalent certifications and relevant work experience.2+ years of hands-on EH&S work… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to assure compliance with PV agreements.Participate in audit and inspection readiness activities. Provide input for re mediating PV system deficiencies cited ... in audit/inspections. Manage the implementation of effective corrective and preventative action PV Agreements and Contracts: Manages PVAs/SDEAs and maintains oversight of PV relevant contracts. Contribute to overseeing and setting standards for PV contract… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …SME to support Quality Investigations, Corrections, and QMS records.Build the Site Readiness of MES for FDA and/or Other Regulatory Audits / Inspections.This ... individual is responsible for the training of Manufacturing Excellence on MES utilization and ensuring that Manufacturing Excellence properly assesses updates and impact.Key Relationships: establish key stakeholder relationships with internal and external… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …internal and external stakeholders to execute audits effectively.Support inspection readiness by preparing clinical teams, Clinical Safety and Pharmacovigilance ... (CSPV) and post marketing stakeholders for key Health Authority pre-approval and sponsor-monitor inspections; provide inspection management support and follow-up activities post inspection regarding compliance commitments are fulfilled on time and that… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …a Right First Time culture of quality, permanent inspection readiness compliance mindset and passionately drives continuous improvementProvides technical expertise ... in area of responsibility by effectively interfacing and collaborating with key stakeholders and functionsActively participates in all regulatory and internal audits of the facilityPartner and manage relationships with contractors to ensure quality of work and… more
- Twist BioScience (South San Francisco, CA)
- …utilization. Ensure robust system performance, availability, and audit readiness through proactive monitoring and maintenance.Cross-Functional Collaboration: Partner ... closely with the platform architecture and infrastructure teams, Manufacturing Operations, Quality Assurance, Process Development, and Regulatory Affairs teams to define MES requirements, design seamless integrations with other enterprise systems (eg, ERP,… more
