Role & responsibilities Support the DSCSA reconciliation process by assisting with daily and weekly reporting activities. Format, clean, and analyze Excel datasets containing shipment and serialization information. Interact with Level 4 (L4) vendor systems to perform basic data validation and processing tasks. Read, interpret, and manage XML files related to serialized pharmaceutical product data. Manage and track tickets raised with the L4 system using Salesforce ticketing platform. Collaborate with cross-functional teams to investigate and resolve data discrepancies promptly. Preferred candidate profile Candidate should have good experience in DSCSA Serialization , L4 System for US Market. Interested candidates may apply on Madhura.patil@rubicon.co.in
Role & responsibilities We are seeking an experienced and proactive Project Manager to lead the end-to-end execution of pharmaceutical development and commercialization projects, specifically for Solid Oral Dosage Forms and Liquid Orals . The selected candidate will manage cross-functional coordination from product development, technology transfer, regulatory filing to Approvals , ensuring all project milestones are delivered on time, within scope, and in full compliance with business and regulatory requirements. Skills and Competencies: Deep understanding of pharmaceutical product development, technology transfer & Familiarity with global regulatory frameworks and dossier submission processes Strong competency in project planning, risk management, and cross-functional leadership . Proficiency in Microsoft Project, Excel and PowerPoint for real-time project tracking and reporting. Excellent stakeholder management, communication, negotiation and leadership skills . Highly organized, proactive and solution-focused approach to project management. Key Attributes: Collaborative and team-oriented leadership style . Strong analytical thinking and problem-solving capabilities. Ability to perform effectively under tight deadlines in a regulatory-compliant environment . High degree of ownership, accountability, and customer-centric mindset . Key Responsibilities: Lead the planning, execution, and delivery of pharmaceutical projects encompassing Formulation Development, Analytical Development, Regulatory Filing, Manufacturing, and Supply Chain from initiation through Product Approval. Develop and maintain comprehensive project plans including timelines, milestones, resource allocation and risk mitigation strategies using standard project management tools. Coordinate cross-functional teams including R&D, Regulatory Affairs, Quality Assurance, Production, Supply Chain, and Business Development to ensure effective collaboration and timely execution. Manage technology transfer activities from R&D to manufacturing, ensuring robust scale-up, validation, and readiness for commercial production. Serve as the central communication point for internal teams and external partners, ensuring alignment on project goals, timelines, and deliverables. Ensure regulatory submission preparedness for assigned projects and provide active support during dossier filing and query resolution for designated markets. Identify potential risks, establish risk mitigation strategies , and ensure early resolution to maintain project timelines and objectives. Monitor project budgets and resource allocations to ensure optimal utilization, escalating deviations where necessary to maintain alignment with organizational goals. Organize and facilitate regular project review meetings ; prepare clear, data-driven status reports and dashboards for senior management. Ensure strict compliance with GMP, global regulatory guidelines (USFDA, EMA, WHO, MHRA, etc.) , and internal quality standards throughout the project Lifecycle Preferred candidate profile Candidate should have hands on experience in R&D Project Management, People management, Stakeholder Management etc. the incumbents' project management experience should be 5+ years. Interested candidates may apply on madhura.patil@rubicon.co.in Call me on 9892423060 to discuss more on this role.
Role & responsibilities To perform method development and validation for Extractable and Leachables, Nitrosamine and another specific impurity by LCMS (GCMS and ICPMS added advantage) To prepare analytical method validation protocols for various validation by ICP-MS, GC-MS and LC-MS To prepare Technology transfer Protocol and reports. Technology transfer of LCMS method (leachable content, NDSRI and Genotoxic Impurity). Responsible for calibration of analytical pH meter, Balance, ICP-MS, LCMS and GCMS instruments. Responsible for preparation AMDR, Validation Reports, E&L and NDSRI reports. Responsible for ensuring compliance with GLP, Safety and Environment requirements. Participate in training session . Participate effectively in investigations related to deviations/incidences and to suggest CAPA. Preferred candidate profile Candidate should have hands on experience in method development and validation for Extractable and Leachable by LCMS. The candidate should be willing to travel to Plant for method Transfer activities. Interested candidates may apply on madhura.patil@rubicon.co.in Call me on 9892423060 to discuss in details on the role.
Role & responsibilities The incumbent will responsible for of Alternate vendor development, Additional strength management, Site Transfer, and core product development. Responsible for formulation and process development of oral dosage forms, including oral solid and liquid formulations. Troubleshooting and problem-solving of unresolved or new formula issues. Design and execute formulation trials and evaluate stability data to finalize formulation composition. Develop manufacturing processes for R&D formulations so that the technical transfer is successful for large scale batches. Assist to alternate vendor development formulation activities along with product development of site transfer project. Write/review master formulas, manufacturing procedures, SOPs, stability protocols/reports, process validation protocols/reports, Product Development Reports, QOS etc. Support the manufacturing of exhibit/submission batches per regulatory requirements. Support technology transfer for manufacturing processes from laboratory scale to production scale. Works with Analytical Method Development, Regulatory Affairs, Quality Control, Quality Assurance, Inventory Control, etc. to expedite the development and approval of new products by FDA. Assure that all formulation and process development activities are documented in the notebook as per company procedures and cGMPs. Preferred candidate profile Candidate should have hands on experience in Formulation development for US Market. Interested candidates may apply on madhura.patil@rubicon.co.in. Call me at 9892423060 to discuss more on the role