- Insmed Incorporated (NJ)
- …and develop team members. Proactively plan for the future to ensure readiness and effectiveness of the team.Strategy Development -Partner across medical affairs and ... cross-functionally to develop strategy relating to IME and External Research to fill educational gaps and research needs including developing the areas of interest, determination for need of RFPs, when to fund for pipeline brands, etc.Operational Excellence -… more
- Insmed Incorporated (NJ)
- …Supply Chain to ensure compliance with eTMF documentation and audit readiness activitiesSupport regulatory filings (IND/CTA/IMPD), act as SME during inspections, ... perform risk assessments for supply interruptions and implement and complete mitigation strategiesCollaborate on system design, UAT testing, maintenance, to ensure robust supply tracking and randomization supportCollaborate with CMC, Clinical Ops, Quality,… more
- Cipla (Fall River, MA)
- …for launch planning, launch risk mitigation and launch supply readiness . Responsible for collaborating with Cipla global stakeholders particularly Integrated ... Product Development (IPD) and Quality Assurance (QA) to incorporate technical best practices including QbD principles in all technical studies. Participate and/or lead technical due diligences on projects where Cipla is actively engaged with a potential… more
- Sabre (Dallas, TX)
- …runners, feature flags), observability, FinOps, vendor/MSP oversight, and production readiness to ensure secure, resilient, and cost-efficient delivery for product ... track scorecards, and run operational business reviews. + Production readiness & cutover support - Own production readiness... readiness & cutover support - Own production readiness gates, run cutover rehearsals, rollback plans, and validate… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …procedures.Support regulatory inspections and audits by ensuring inspection readiness within facility.Perform internal housekeeping audits.Perform analysis on ... quality indicating data and identifying trends.Provide oversight for trending of quality compliance metrics.Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.Works in a collaborative team setting… more
- AUROBINDO (Durham, NC)
- …processes from pilot to exhibit and commercial scaleMaintains a state of readiness of the MDI process equipment by performing preventive maintenance, calibration or ... functional modification as necessaryCharacterizes active pharmaceutical ingredients (APIs) for respiratory products using techniques such as particle size by laser diffraction, Karl Fischer (KF) moisture analysis, thermogravimetric analysis (TGA), and… more
- AUROBINDO (Durham, NC)
- …implementation and upgrades.Manage change control for validated systems.Support audit readiness and respond to regulatory inspections.Train stakeholders on CSV ... requirements and best practices.Participate in risk assessments and impact analysis for system changes.Support validation activities including IQ/OQ/PQ for IT systems.Maintain QA documentation in accordance with SOPs and regulatory guidelines.Provide training… more
- Merck & Co. (Montgomery County, PA)
- …programs including vendor selection, SOP development, budgeting, and launch readiness .Manage day-to-day operations of the patient support program, ensuring timely, ... high-quality patient interactions and case management.Act as primary liaison with commercial, medical affairs, market access, legal/compliance, pharmacovigilance, and external partners to ensure integrated program deployment.Develop and maintain relationships… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …continuous improvement initiatives leveraging Lean/Six Sigma methodologies.Maintain inspection readiness and contribute to regulatory inspection support.In depth ... understanding of S&OP, production planning and materials management processesAn ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environmentAbility to work independently… more
- Eisai, Inc (Exton, PA)
- …with external providers. Assess and document CMO/CRO analytical proficiencies and readiness to perform various types of assays. Support analytical method transfers ... by co-leading vendor due diligence activities as well as review and/or author all method transfers related documents.Review laboratory data to support product release, characterization, stability assessment, assay validation, and process development, while… more
