Company Overview: Rubicon Research Limited is a fast-growing pharmaceutical formulation company delivering value to our customers and investors by developing, manufacturing, and marketing branded specialty and generic prescription pharmaceutical products in regulated markets. Our product portfolio comprises over 250 SKUs across more than 70 product families. We have an established marketing, sales, and distribution platform in the US through our subsidiaries AdvaGen Pharma which markets non-branded prescription products, and Validus Pharmaceuticals which markets branded prescription products and promotes them to healthcare practitioners in the US. We have two US FDA-inspected R&D facilities – one each in India and Canada, and two manufacturing facilities in Maharashtra, India with multiple accreditations from multiple regulatory agencies such as US FDA, Food and Drugs Administration, Maharashtra (WHO-GMP accreditation) and Health Canada. Our facilities are equipped with various drug development and manufacturing capabilities across dosage forms. Headquartered in Thane, India we have a sales and marketing office in New Jersey, USA. For additional information visit www.rubicon.co.in Position Overview: Senior Manager BD – SEA and China will be responsible for driving business growth, expanding market access, and managing partnerships within the South Esat Asia and China. This role requires deep market knowledge, prior visits and strong relationship management, and strategic execution to establish Rubicon’s presence in these regions. Key Responsibilities: Market Expansion & Business Development: Develop and implement strategies to enhance Rubicon’s footprint in SEA and China. Distributor & Partner Management: Identify, onboard, and manage partnerships with distributors, regulatory agencies, and licensing partners. Regulatory & Compliance Support: Work closely with regulatory teams to ensure smooth product approvals and address market-specific challenges. Commercial & Sales Strategy: Develop pricing, and sales strategies tailored to regional market dynamics. Competitive Analysis & Intelligence: Monitor industry trends, competitor activities, and regulatory changes to stay ahead in the market. Revenue & Target Management: Set and achieve revenue and growth targets within the assigned regions. Key Qualifications & Experience: Bachelor’s degree in Pharmacy, Life Sciences, Business Administration, or a related field; 10+ years of experience in pharmaceutical business development with exposure to SEA and China markets with at least 3+ years in a Managerial role. Proven experience in managing distributor relationships and regulatory processes. Strong negotiation, communication, and strategic thinking skills. Willingness to travel extensively. Show more Show less
Job Title: Assistant General Manager Department: Quality Assurance Location: Ambernath Years of Experience: 16 + Years Dosage Form: Solid Oral/ Nasal Job Responsibilities: To ensure cGMP Compliance as per laid down procedures. Execute and Monitor key QA activities - Process validation, Cleaning Validation, Equipment Qualification, Instrument Qualification, Utility Qualification and Master Document review. Preparation and review of SOPs applicable to QA. Evaluation of QMS documents. Preparation of Validation Master Plan, review of process validation, equipment qualification and cleaning validation protocols and reports Participate in investigations and review of investigations. Monitoring of Exhibit and Submission batches documentation and Coordination with RA for document submission Monitoring of document control, storage, and archival. To provide training to QA team members and other functions. Participate in customer and regulatory inspections and ensuring CAPA effectiveness. Participate in self-inspections. To audit the internal quality system as a part of self-inspection (internal audit). Timely and proactively escalating issues. Qualifications & Pre-Requisites Must-Have Skills: B. Pharm/ M. Pharm With relevant experience in pharma quality assurance. Must have knowledge of Process Validation, Cleaning Validation, Equipment Qualification and ability to handle the team. Exposure to various regulatory bodies such as US FDA, EU-GMP, MHRA, TGA. Exposure to specific dosage forms like OSD and Nasal. Must have shop floor experience and in-process quality assurance. Effective communication, Team coordination and work in collaboration within compliance Show more Show less
Sound analytical knowledge required in “Physical Performance” testing of Nasal products for Packing Material and Finished Product. Experience in reviewing analytical raw data for accuracy and completeness, ensuring timely submission of final data to QA or other relevant departments. Accountable for completion of method validation, verification, and method transfer activities related to Physical Performance Testing. Responsible for calibration and preventive maintenance (PM) of all nasal testing instruments. Responsible for handling QMS activities (Incidents, Investigations, OOS, OOT, Change Control, CAPA, etc.) and ensuring closure within stipulated timelines, supported by proper root cause analysis for the respective section. Expected to represent the department during audits (USFDA, MHRA, Client, etc.). Must possess strong written and verbal communication skills. Accountable for ensuring adherence to Good Laboratory Practices (GLP) and Health, Safety, and Environment (HSE) systems in the laboratory. Qualifications: Master Degree of Science / Pharma. The candidate should have handling experience and theoretical knowledge on all type Nasal instrument testing. He should have experience of QMS Handling and know about GLP-GMP standard of analytical work. The candidate having experience in US-FDA/MHRA approved company is preferable. Knowledge of Chromeleon 7.2 software & Viota software is most preferable Show more Show less
Company Overview: Rubicon Research Limited is a fast-growing pharmaceutical formulation company delivering value to our customers and investors by developing, manufacturing, and marketing branded specialty and generic prescription pharmaceutical products in regulated markets. Our product portfolio comprises over 250 SKUs across more than 70 product families. We have an established marketing, sales, and distribution platform in the US through our subsidiaries AdvaGen Pharma which markets non-branded prescription products, and Validus Pharmaceuticals which markets branded prescription products and promotes them to healthcare practitioners in the US. We have two US FDA-inspected R&D facilities – one each in India and Canada, and two manufacturing facilities in Maharashtra, India with multiple accreditations from multiple regulatory agencies such as US FDA, Food and Drugs Administration, Maharashtra (WHO-GMP accreditation) and Health Canada. Our facilities are equipped with various drug development and manufacturing capabilities across dosage forms. Headquartered in Thane, India we have a sales and marketing office in New Jersey, USA. For additional information visit www.rubicon.co.in Position Overview: The General Manager, Supply Chain will be responsible for overseeing and managing all aspects of the supply chain operations within Rubicon Research Ltd. This includes managing Supply planning, material planning, logistics, inventory management, supplier relationships, and distribution (Exports) to ensure timely delivery of products while optimizing bet in class OTIF, cost optimisation, and customer satisfaction. The role will also require strategic planning to streamline operations and drive continuous improvements in the end-to-end supply chain process. The main focus is required in employing TOC, rigor to the set process and constant need to innovate. Completely own the S&OP process of the organisation and responsible for the aligned service levels and cost. Key Responsibilities: Leadership & Strategy Develop and execute the overall planning and logistics strategy, aligning with the company’s goals and vision. Lead and mentor the planning and logistics teams, fostering a culture of high performance, collaboration, and continuous improvement. Identify and implement best practices and process improvements to drive operational efficiency and effectiveness. Oversee the end-to-end supply chain operations, including procurement planning, inventory management, transportation. Ensure supply chain activities are efficient, cost-effective, and aligned with company objectives. Right utilisation of space and inventory. Monitor and evaluate supply chain KPIs (Key Performance Indicators) to ensure operational goals are met. Supplier & Vendor Management Build and maintain strong relationships with key suppliers and 3pl vendors, freight forwarders. Negotiate contracts, terms, and pricing with to secure cost-effective agreements. Identify new suppliers, assess their capabilities, and ensure a reliable supply of materials. Inventory Control & Supply Planning Manage inventory levels to optimize stock availability while minimizing excess inventory and stockouts. Collaborate with sales and production teams to ensure production plan is there in place for the Quarter, monthly. Ensure weekly and daily production schedules at various plants and align inventory levels accordingly. Implement effective inventory management systems and processes to ensure accuracy and efficiency Logistics & Distribution Oversee logistics operations, including inbound and outbound transportation and export logistics , distribution. Optimize logistics networks and make right choice of mode of transportation to ensure timely and cost-effective delivery of goods to customers. Coordinate with third-party logistics providers to ensure smooth operations. Financial Management Develop and manage the supply chain budget, ensuring effective use of resources and cost control. Identify opportunities for cost reduction without compromising quality or service delivery. Own the Executive S&OP, Service adherence reports on supply chain performance and present to senior management. Risk Management & Compliance Identify potential supply chain risks (e.g., supply disruptions, delays, quality issues) and develop mitigation strategies. Ensure compliance with relevant regulations, safety standards, and sustainability goals in supply chain operations. Continuous Improvement Lead process improvement initiatives to enhance efficiency and effectiveness across the supply chain. Foster a culture of innovation and continuous improvement in the supply chain team. Key Qualifications & Experience: Education: Bachelor’s degree in supply chain management, Business Administration, or related field; MBA or advanced degree preferred. Experience: Minimum of 10 years of experience in supply chain management, with at least 5 years in a leadership role. Industry preference: The Incumbent must be from FMCG industry. Knowledge: Expertise in supply chain management, supply planning, logistics, and inventory management. Proficiency in supply chain software (e.g., SAP, Excel macro, Solver, optimisation tools). Strong analytical, problem-solving, and decision-making skills. In-depth knowledge of Theory of Constraints, business processes & improvement methodologies. Leadership: Proven ability to lead and motivate cross-functional teams. Communication: Strong interpersonal and communication skills, with the ability to collaborate effectively across departments. Global Perspective: Experience managing global supply chains and working with international suppliers. Work Environment & Physical Demands Office-based with occasional visits to warehouses, manufacturing facilities, or supplier locations. Some travel may be required.
Rubicon Research Limited is a fast-growing pharmaceutical formulation company delivering value to our customers and investors by developing, manufacturing, and marketing branded specialty and generic prescription pharmaceutical products in regulated markets. Our product portfolio comprises over 250 SKUs across more than 70 product families. We have an established marketing, sales, and distribution platform in the US through our subsidiaries AdvaGen Pharma which markets non-branded prescription products, and Validus Pharmaceuticals which markets branded prescription products and promotes them to healthcare practitioners in the US. We have two US FDA-inspected R&D facilities – one each in India and Canada, and two manufacturing facilities in Maharashtra, India with multiple accreditations from multiple regulatory agencies such as US FDA, Food and Drugs Administration, Maharashtra (WHO-GMP accreditation) and Health Canada. Our facilities are equipped with various drug development and manufacturing capabilities across dosage forms. Headquartered in Thane, India we have a sales and marketing office in New Jersey, USA. For additional information visit www.rubicon.co.in Position Title: Assistant Manager-Specialty Project Management Type: Full time Location: Thane, Maharashtra. Department : Specialty Portfolio Management & Research Job Summary: The incumbent - will be responsible for managing the development of New Drug Applications (NDA) projects The role requires strategic planning, cross-functional coordination and risk management to ensure successful project execution from initiation to the proof-of-concept (POC) stage. Key Responsibilities: Project Planning & Execution: Develop and maintain project timelines, budgets and risk mitigation plans to meet critical milestones Manage pipeline of 505(b)(2) and complex generic product development projects Ensure compliance with FDA’s r egulatory requirements Regulatory & NDA Submission Strategy: Coordinate pre-NDA meetings and address FDA queries during the review process. Ensure CMC (Chemistry, Manufacturing, and Controls) readiness for regulatory submissions. Work closely with Regulatory Affairs teams to support NDA, and ANDA filings. Cross-Functional Leadership & Stakeholder Management: Collaborate with R&D, Clinical, Regulatory, Supply Chain and Commercial teams to ensure project alignment. Ensure project governance meetings and provide regular updates to senior leadership. Engage with external partners (CDMOs, CROs, CMOs, API suppliers, KOLs) for project execution. Risk Management & Problem Solving: Identify and mitigate technical, regulatory and commercial risks associated with new or complex dosage forms . Resolve project bottlenecks by driving proactive solutions with cross-functional teams. Qualifications & Skills: Education: M. Pharm or PhD, in Pharmaceutical Sciences or related field. MBA is a preferred in addition to M. Pharm. Experience: 5-7 years of experience in pharmaceutical project management , with a focus on NDA, 505(b)(2) and complex generics. Proven track record in NDA submissions and approval processes . Experience with injectables, inhalation/nasal sprays, transdermal, liposomes, peptides, long acting injectables, OSD, or other complex drug delivery systems . Project Management Skills: Proficiency in MS Project, Excel or other project management tools . Regulatory Knowledge: Strong understanding of FDA, and ICH guidelines for NDA and complex products. Hands-on experience with CMC, Clinical & Regulatory aspects of NDA filings . Soft Skills: Excellent communication and stakeholder management skills. Strong problem-solving, analytical, and leadership capabilities. Ability to manage multiple projects under tight deadlines. Preferred Experience: Experience working with CDMOs, CROs, and external partners for product development. Knowledge of cGMP, ICH, and pharmaceutical quality systems . Qualifications & Skills: Education: M. Pharm or PhD, in Pharmaceutical Sciences or related field. Proven Track record in Project Management.
About Rubicon Research: Rubicon Research Limited is a fast-growing pharmaceutical formulation company dedicated to delivering value to customers and investors through the development, manufacturing, and marketing of branded specialty and generic prescription pharmaceutical products in regulated markets. With a product portfolio of over 250 SKUs across more than 70 product families, Rubicon Research has established a strong presence in the US market through its subsidiaries AdvaGen Pharma and Validus Pharmaceuticals. The company operates two US FDA-inspected R&D facilities in India and Canada, along with manufacturing facilities in Maharashtra, India, equipped with various drug development and manufacturing capabilities. Headquartered in Thane, India, Rubicon Research also maintains a sales and marketing office in New Jersey, USA. For more information, please visit www.rubicon.co.in. Position Title: Senior Executive-Formulation Development Type: Full-time Location: Thane, Maharashtra. Key Responsibilities: - Develop new products and optimize existing formulations for various dosage forms (Tablets, Capsules, Solutions, Suspensions, Pellets, MUPS) targeting regulated markets like the US, Europe, and ROW. - Conduct literature and patent searches, reviews, discussions, and documentation. - Perform API characterization, preformulation studies, and other related activities. - Plan and execute laboratory experiments on a daily basis. - Develop prototype formulas, optimize formulations and processes. - Prepare relevant documents such as MFC, BMR, STP, PDR, CPS, etc. - Collaborate with other departments including Stores, QA, RA, BD, IP sphere, CTS site, etc. - Coordinate with the Analytical Group for regular analysis of experimental samples. - Ensure effective execution of technology transfer activities at the manufacturing site. Qualifications & Pre-Requisites: - Master's in Pharmacy (Pharmaceutics). - Must-Have Skills: Formulation development experience in Solid & Liquid Oral products; experience with Pellets projects is preferred.,
Rubicon Research Limited is a fast-growing pharmaceutical formulation company committed to delivering value to customers and investors through the development, manufacturing, and marketing of branded specialty and generic prescription pharmaceutical products in regulated markets. With a diverse product portfolio of over 250 SKUs across more than 70 product families, Rubicon Research has established marketing, sales, and distribution platforms in the US through its subsidiaries AdvaGen Pharma and Validus Pharmaceuticals. The company boasts two US FDA-inspected R&D facilities in India and Canada, along with two manufacturing facilities in Maharashtra, India, that hold accreditations from various regulatory agencies. Equipped with advanced drug development and manufacturing capabilities across dosage forms, Rubicon Research is headquartered in Thane, India, with a sales and marketing office in New Jersey, USA. Position Title: Head of Business Application Type: Full time Location: Thane, Maharashtra As the Head of Business Application at Rubicon Research, you will be tasked with leading all business applications across the organization's locations, including its US and Canada subsidiaries. Your primary responsibility will be to spearhead the digital transformation agenda at Rubicon, collaborating with key stakeholders to ensure top-notch business applications across all functions. Key Deliverables: - Develop a roadmap for Digital Transformation by staying abreast of technology trends, benchmarking with industry peers, and aligning with business functions to enhance operations. - Drive the digital transformation agenda focusing on digitizing paper-based processes, leveraging SAP S4/Hana, enhancing quality systems, implementing Warehouse Management Systems (WMS), and managing master data governance. - Design and implement a robust technology stack for Business Analytics and Dashboarding to improve business results. - Define the IT Agenda encompassing Run, Grow, and Transform aspects, manage project portfolios and resources effectively. - Establish and enhance the IT operating model to consistently deliver business benefits aligned with the IT vision. - Ensure compliance with organizational objectives, policies, and standards, and provide regular project status reports to management. - Anticipate and communicate any project delays or conflicts to management promptly, evaluate, appoint, and oversee system implementors and support partners. - Uphold quality requirements, document system processes and configurations, and conduct regular meetings with vendors and teams to monitor progress and address project-related issues. - Clarify project scope, develop project plans, identify resource requirements, and define clear deliverables and responsibilities for internal teams and vendors. - Research and evaluate software technology options for large-scale projects, considering cost-benefit analyses. Ideal Profile: - Experience in managing business application and automation projects in SAP environment. - Hands-on experience in overseeing automation projects involving diverse stakeholders. - Preferably from a Pharma company operating in regulated markets or a consumer company with advanced IT systems. - Strong understanding of business processes. Key Behavioral Traits: - Problem-solving skills - Collaboration abilities - Process-oriented mindset - Adaptability - Ambitious and driven attitude For more information, please visit www.rubicon.co.in.,
Company Overview: Rubicon Research Limited is a fast-growing pharmaceutical formulation company delivering value to our customers and investors by developing, manufacturing, and marketing branded specialty and generic prescription pharmaceutical products in regulated markets. Our product portfolio comprises over 250 SKUs across more than 70 product families. We have an established marketing, sales, and distribution platform in the US through our subsidiaries AdvaGen Pharma which markets non-branded prescription products, and Validus Pharmaceuticals which markets branded prescription products and promotes them to healthcare practitioners in the US. We have two US FDA-inspected R&D facilities – one each in India and Canada, and two manufacturing facilities in Maharashtra, India with multiple accreditations from multiple regulatory agencies such as US FDA, Food and Drugs Administration, Maharashtra (WHO-GMP accreditation) and Health Canada. Our facilities are equipped with various drug development and manufacturing capabilities across dosage forms. Headquartered in Thane, India we have a sales and marketing office in New Jersey, USA. For additional information visit www.rubicon.co.in Position Overview: The role will be responsible for Strategic Procurement and Sourcing of APIs. Key area- handling the vendor/partner relations, Responsible for the long-term and short-term contracts. The role will be SPOC for all vendor-related communications; follow ups and documentation related to the new development. Key Responsibilities: Strategic Procurement: Develop and implement category strategy for API Sourcing and procurement. Technical evaluation & Sourcing of API for US and other regulated market. Identify, evaluate, and onboard suppliers and manufacturers. Ensuring the availability of API for commercial production as well as new development. Conduct cost benchmarking and drive cost-saving initiatives while maintaining quality and regulatory standards. Negotiate supply contracts with suppliers ensuring optimal terms (pricing, lead times, quality, IP rights, etc.). Operational Procurement: Prepare and manage the annual procurement plan aligned with project development timelines and market launch requirements. Ensure timely procurement of APIs for development, validation, and commercial supplies. Monitor supplier performance (OTIF, quality incidents, pricing accuracy). Coordinate with logistics and warehousing teams for inbound movement and inventory management. Documentation & Regulatory Support: Maintain comprehensive procurement documentation including CDA/ NDA, MSAs, QAA, vendor qualification documents, COAs, DMFs, etc. Ensure supplier documents and information are aligned with regulatory filing requirements for USFDA, EMA, TGA, etc. Support Regulatory Affairs in compiling and submitting documentation related to combination product registration. Track and manage QMS documentation (change controls, deviations, audit CAPAs) from procurement standpoint. Facilitating Audit requirement to meet QA compliance Cross-functional Coordination: Liaise with R&D and Tech Transfer teams to understand component requirements during development. Work with QA/RA for supplier audits, compliance checks, and dossier support. Collaborate with finance for budgeting, payment terms, and working capital optimization. Need to work with the Central and factory QA, QC teams, R&D, Supply Planning, Procurement, Project management, Portfolio development, Contract manufacturing teams. Key Qualifications & Experience: Education: B.Pharm/B.E/B.Tech with MBA (Supply Chain/Operations/Strategy) preferred. Experience: 3-4 years in pharma procurement at least 1-2 years in API category. Exposure to regulated markets (US, EU, etc.) is mandatory. Experience in dealing with global suppliers and CMOs is preferred. Negotiation Skill: Knowledge of API Skills & Competencies: Strong understanding of regulatory requirements for combination products. Excellent negotiation, communication, and supplier relationship management skills. Documentation precision with working knowledge of GMP and regulatory guidelines. Proficient in SAP/ERP systems, MS Office, and eQMS platforms. Analytical mindset with problem-solving and risk mitigation orientation. Preferred Attributes: Knowledge of global API suppliers Familiarity with QMS, ISO, 21 CFR & Other regulatory requirement. Ability to manage ambiguity in early-stage product development cycles
Company Overview: Rubicon Research Limited is a fast-growing pharmaceutical formulation company delivering value to our customers and investors by developing, manufacturing, and marketing branded specialty and generic prescription pharmaceutical products in regulated markets. Our product portfolio comprises over 250 SKUs across more than 70 product families. We have an established marketing, sales, and distribution platform in the US through our subsidiaries AdvaGen Pharma which markets non-branded prescription products, and Validus Pharmaceuticals which markets branded prescription products and promotes them to healthcare practitioners in the US. We have two US FDA-inspected R&D facilities – one each in India and Canada, and two manufacturing facilities in Maharashtra, India with multiple accreditations from multiple regulatory agencies such as US FDA, Food and Drugs Administration, Maharashtra (WHO-GMP accreditation) and Health Canada. Our facilities are equipped with various drug development and manufacturing capabilities across dosage forms. Headquartered in Thane, India we have a sales and marketing office in New Jersey, USA. For additional information visit www.rubicon.co.in Position Overview: To manage and deliver digitization projects in the area of Finance. Key Responsibilities: To lead digitization projects by Preparation of project charter with scope, project timeline, effort estimates, governance structure, RACI & success criteria Business Process Optimization and Best Practices To prepare business requirements for current and future with a view to realizing business benefits. Vendor / solution evaluation for digitization projects Configure of SAP FICO module Ensure seamless integration with other SAP modules / non-SAP systems Troubleshoot and resolve SAP Modules related issues and enhancements Support data migration, master data management, Functional Testing and system testing Design learning programs for business on End user training, SAP best standards and technologies. Collaborate with cross-functional teams to ensure smooth system operations Participate in SAP upgrades, patching, and S/4HANA migration projects as needed Ensure effective change management Ensure minimal customization in standard processes. Sort out day-to-day queries of end users. SAP License/User Management To participate in the SAP audits for closure Ensure adherence to safety / compliance guidelines. Maintain Confidentiality, Integrity, and Availability of Company Information. Ensure adherence of organization Information security policy and guidelines. Attend Information Security trainings, awareness sessions and e-learning course. Key Qualifications & Experience: CA – Finance Good understanding on business processes and hands on experience in SAP FICO
As a member of Rubicon Research Limited, you will be at the forefront of managing and delivering digitization projects within the Finance domain. Your role will involve leading these projects, encompassing the preparation of project charters, scoping, establishing project timelines, effort estimation, governance structure definition, RACI identification, and success criteria establishment. Additionally, you will be responsible for optimizing business processes and implementing best practices to drive efficiency and effectiveness. Your duties will include formulating business requirements for current and future needs, with a focus on realizing substantial business benefits. You will also be involved in evaluating vendors and solutions for digitization projects and configuring the SAP FICO module. It will be your responsibility to ensure seamless integration with other SAP modules and non-SAP systems, troubleshoot and resolve SAP modules-related issues and enhancements, support data migration, master data management, functional and system testing, and design learning programs for business users on End user training, SAP best practices, and technologies. Collaboration with cross-functional teams to ensure smooth system operations, participation in SAP upgrades, patching, and S/4HANA migration projects as required, effective change management, and minimal customization in standard processes are also key components of this role. You will also handle day-to-day end-user queries, SAP License/User Management, participate in SAP audits, ensure adherence to safety/compliance guidelines, maintain the confidentiality, integrity, and availability of Company Information, and comply with organization Information security policies. To excel in this position, you should hold a CA Finance qualification, possess a good understanding of business processes, and have hands-on experience in SAP FICO. Your dedication and expertise will contribute significantly to the success of our digitization projects and the overall growth of the organization.,
Rubicon Research Limited is a rapidly growing pharmaceutical formulation company focused on developing, manufacturing, and marketing branded specialty and generic prescription pharmaceutical products in regulated markets. With a diverse product portfolio of over 250 SKUs spanning more than 70 product families, we have established marketing, sales, and distribution platforms in the US through our subsidiaries AdvaGen Pharma and Validus Pharmaceuticals. Our US FDA-inspected R&D facilities in India and Canada, along with manufacturing facilities in Maharashtra, India, equipped with various drug development and manufacturing capabilities, demonstrate our commitment to quality and innovation. As a Manager in Analytical Method Validation at Rubicon Research Limited, you will play a crucial role in overseeing end-to-end activities related to validation and documentation for various regulatory markets. Your responsibilities will include ensuring accurate documentation for analytical method validation, planning daily validation activities, coordinating with the Analytical Development team, reviewing protocols and reports, managing incidences, investigations, and change control processes, and ensuring compliance with quality management systems. Additionally, you will be responsible for training and supporting the Analytical Method Validation team, providing technical input for analytical data generation, addressing analytical issues, and preparing material budgets. Key Qualifications & Experience: - M. Pharm/M. Sc in Organic or Analytical Chemistry - Proficiency in handling instruments such as HPLC, GC, KF, IC, PSD, etc. - Familiarity with US, UK, EU, and ROW regulatory bodies - Experience with GDP and regulatory query handling In this role, you will need to demonstrate a strong understanding of regulatory guidelines, ensure compliance in the laboratory, provide technical training to team members, and review documents through the Document Management System (DMS) following the Quality Management System (QMS). Your expertise will be crucial in maintaining GLP standards, meeting regulatory and quality expectations, and ensuring that all analytical work is audit-ready to meet FDA standards. Please note that the candidate is expected to work in various shifts as required and may need to visit external sites based on project requirements. If you are passionate about pharmaceutical development, regulatory compliance, and analytical method validation, we encourage you to join our dynamic team at Rubicon Research Limited.,
Rubicon Research Limited is a fast-growing pharmaceutical formulation company delivering value to our customers and investors by developing, manufacturing, and marketing branded specialty and generic prescription pharmaceutical products in regulated markets. Our product portfolio comprises over 250 SKUs across more than 70 product families. We have an established marketing, sales, and distribution platform in the US through our subsidiaries AdvaGen Pharma which markets non-branded prescription products, and Validus Pharmaceuticals which markets branded prescription products and promotes them to healthcare practitioners in the US. We have two US FDA-inspected R&D facilities – one each in India and Canada, and two manufacturing facilities in Maharashtra, India with multiple accreditations from multiple regulatory agencies such as US FDA, Food and Drugs Administration, Maharashtra (WHO-GMP accreditation) and Health Canada. Our facilities are equipped with various drug development and manufacturing capabilities across dosage forms. Headquartered in Thane, India we have a sales and marketing office in New Jersey, USA. For additional information visit www.rubicon.co.in Position Title: Manager-Supply Chain Management Type: Full time Location: Thane, Maharashtra. Department : Supply Chain Management Position Overview: We are seeking a highly driven and motivated Supply Planner with good knowledge in Rough cut capacity planning, linear modelling to join our dynamic team. The ideal candidate will play a pivotal role in managing production schedules, material planning, and driving the efficient flow of goods across multiple manufacturing sites. The role demands a go-getter attitude and a keen ability to meet supply chain delivery metrics while collaborating cross-functionally to optimize supply chain processes. Key Responsibilities: RCCP (Rough-Cut Capacity Planning): Utilize RCCP techniques to ensure alignment between capacity and demand across manufacturing sites. Conduct capacity analysis to identify potential bottlenecks and implement solutions for effective resource allocation. Production Scheduling: Develop and manage production schedules to meet demand forecasts, minimizing stockouts and excess inventory. Coordinate with manufacturing teams to ensure timely execution of the production plan. Material Planning: Oversee material requirements planning (MRP) to ensure the timely availability of raw materials and components. Collaborate with procurement and suppliers to maintain appropriate inventory levels and avoid supply disruptions. Manage the lead time and safety stock calculations to ensure uninterrupted production flow. Supply Chain Metrics & KPIs: Manage and track supply chain delivery metrics such as on-time delivery, lead times, and inventory turnover. Proactively identify areas of improvement and implement corrective actions to meet and exceed service level agreements (SLAs). Collaboration & Cross-functional Coordination: Work closely with production, procurement, and logistics teams to ensure seamless operations across the manufacturing sites. Maintain communication with sales and demand planning teams to align on forecast accuracy and production schedules. Problem Solving & Continuous Improvement: Analyze supply chain disruptions, resolve issues, and drive process improvements to reduce lead time and cost. Propose initiatives to improve efficiency, reduce waste, and enhance production and material planning processes. Documentation & Reporting: Prepare regular reports on production and material planning, highlighting risks, shortages, and capacity challenges. Ensure accurate and up-to-date records of all supply chain activities. Qualifications Bachelor's degree in Supply Chain Management, Operations, or a related field (or equivalent experience). 3+ years of experience in supply planning, material planning, or production scheduling. Strong understanding of RCCP methodologies, production scheduling, and material requirements planning (MRP). Proven track record of managing supply chain delivery metrics in a fast-paced manufacturing environment. Excellent problem-solving skills and a results-oriented mindset. Proficient in ERP and planning software (e.g., SAP, Oracle, or similar tools). Strong communication and interpersonal skills with the ability to work collaboratively across teams. Ability to thrive under pressure and meet tight deadlines. Preferred Skills: Advanced knowledge of lean manufacturing principles and continuous improvement processes. Experience managing supply chain operations across multiple manufacturing sites. Certification in APICS or equivalent (e.g., CPIM, CSCP) is a plus.
Purpose: The position is for working on product registrations in Mexico and LATAM including compiling dossiers, answering queries from regulatory agencies, liaising with the cross-functional teams to obtain needful documents for product registration and co-ordinate on the requirements from the regional partners and regulatory agents. Managing the work deliverables by ensuring balanced and timely co-ordination with BD, regulatory agents and cross-functional stakeholders. Job Responsibilities: Preparing and submitting regulatory dossiers in Mexico and LATAM countries. Managing the work deliverables by ensuring balanced and timely co-ordination with BD, regulatory agents and cross-functional stakeholders. Liaising with the cross-functional teams for documents for registration and reviewing them. Liaising with regulatory agents in Mexico and LATAM countries and addressing their requirements for regulatory filings. Addressing any queries or deficiencies from the regulatory agencies or partners or regulatory agents and ensuring product registration in the shortest time. Addressing any post approval requirements and filings. Ensuring the dossiers are submitted and registered as per the schedule. Qualifications & Pre-Requisites: Regulatory experience in Mexico and LATAM markets at managerial position. Should be an M.Pharm/M.Sc Good communication and planning skills. Additional notes Will need to work in different shifts.
Purpose Responsible for the development of new products and optimization of existing formulations; product lines including Solid and Liquid Dosage forms (Tablets, Capsules, Solutions, Suspensions, Pellets, MUPS etc.) for regulated markets like US, Europe and ROW. Location: Thane, Maharashtra Job Responsibilities / Deliverables To understand project scope, define the activities and timelines and ensure periodic monitoring and timely completion of the same. To lead on the execution/development of new formulations by investigating characteristics of API and its viability, safety and compatibility with other ingredients, defining the material characteristics, performing required testing, and conducting scale up studies. To identify the resource requirement for the projects such as materials, manpower, machine change parts as well as to assimilate all the literature information collected by project teams and ensure appropriate usage throughout development. Develop R&D plans and experimental designs by applying QBD principles for all new product development projects and processes: Analyze data to provide a relevant interpretation, draw valid conclusions and make appropriate recommendations for further advancement in product development. To effectively plan & coordinate execution of lab scale up/ optimization and pilot BE batches by ensuring strict adherence to lab GMP system and practices. Timely review of Lab experiment notebooks as well as preparation and review of technology transfer documents To liaison and coordinate with technology transfer team / production team of respective manufacturing site to ensure seamless technology transfer by executing plant scale-up and exhibit batches as well as to review batch manufacturing and process validation documents. Program for the optimization of existing product performance by investigating API characteristics and finished products, researching viability, safety and compatibility of ingredients and formulas. Check stability protocols, monitor stability studies and evaluate/interpret the results to advance further for product development activity accordingly. To liaison and communicate with various other departments such as project management, analytical development, supply chain team, clinical, regulatory and IP department as per the required product development activity to ensure timely completion of the project. To prepare new departmental SOPs, manuals and guidelines documents as on when required as well as to renew existing SOPs, manuals and guidelines documents. To monitor IQ, OQ and PQ activities of new machines and to ensure proper functioning & maintenance of all equipment & instruments including necessary. To ensure proper training of the subordinates, technicians and housekeeping personnel on various equipment, instruments and systems in the department. To ensure proper storage & destruction of raw materials & finished goods and to maintain up to date RLD samples inventory. To participate in the departmental Audits and ensure compliance to the recommendations. To read and update oneself/ team with the latest developments w.r.t. technology, conceptual thinking, presentation and communication skills. Qualifications & Pre-Requisites Master in pharmacy (Pharmaceutics) Must-Have Skills: Formulation development experience of Solid & Liquid Oral; preferred to have Pellets project experience. Additional notes Role is expected to work in extended hours/any of the shift based on the requirement. Expected to visit manufacturing sites, whenever required.
Purpose The prerequisite is the ability to handle large teams (30+ members) in QC, including an AMV team. The primary responsibility for leading the LC-MS, Nasal analytical, FT-NIR analytical teams for regular testing/method validation activities. The secondary is responsible for back-up support to the QC-HOD with daily updates, monthly sample status, Lab management, training, monthly review meetings and co-ordination with all stakeholders to align the work as per requirements. Location: Ambernath, Maharashtra Job Responsibilities: Primarily responsible for leading the QC-AMV team size of 30+members (LC-MS, Nasal and FT-NIR team) for regular testing/method validation activities and with sound analytical knowledge and good leadership qualities to achieve company goals. Secondary responsible for back-up support to the QC HOD with daily update, commercial output, monthly sample status, Training, monthly review meeting and co-ordination with all stakeholders to align the work as per requirements . Responsible for Execution & approval of different types of QMS (OOS, OOT, Investigation etc) and identify scientific root causes with effective CAPA and maintain Lab compliance. Responsible to design and executing planning of analysis (Routine work, Method validation and Method transfer), data interpretation and presenting to HOD. Should be self-driven, have the capability to make self-decision and be a good learner. Providing guidance to team members for improving the work quality and monitoring and reporting on key performance indicators (KPIs). Shall be responsible for leading all types of QC-AMV work in the absence of QC-HOD and actively participate in departmental improvement programs to enhance the Output and Quality. Collaborating and coordinating with cross-functional teams like QA, RA, R&D and PMI to proceed the allocated task with ownership and accountability. Stay updated on industry developments and emerging trends to ensure they remain competitive for LC-MS and FT-NIR techniques. Responsible for adherence to GLP and Health, Safety Environment system in Laboratory and responsible for facing the FDA Audit (US, MHRA, EU) individually. Qualifications & Pre-Requisites Preferably have the following skill but not limit as mentioned below. Master Degree of Science / Bachelors or Master Pharma. Should have strong analytical knowledge and expertise in modern analytical instruments (Like: HPLC, GC, LC-MS or NIR or Nasal performance testing etc) with the ability to interpret complex data and generate insights. Preferably mix work experience in QC, AMV and AD departments. Strong leadership skills with a proven ability to motivate and develop team members. Exceptional problem-solving skills and a strategic mindset. Solid organisational and time management skills, with the ability to manage multiple projects and deadlines. Knowledge of Chromeleon 7.2 and Sciex software will be an added advantage. Should have good working experience in GMP and USFDA/EU Audit faced. Should have skill to achieve deliverable tasks with minimum support for analysis. Should have excellent written and verbal communication skills, with the ability to present findings clearly and effectively Additional notes The role is expected to manage the work in all shifts. If required he might need to travel to Satara, Thane site, Indore site on work priority as per company policy. Responsible for ensuring compliance with GLP, Health, Safety and Environment. requirement.
As a Product Development Manager, you will be responsible for developing new products and optimizing existing formulations for various dosage forms such as Tablets, Capsules, Solutions, Suspensions, Pellets, MUPS, etc. Your primary focus will be on regulated markets like the US, Europe, and ROW. Key Responsibilities: - Define project scope, activities, and timelines, and monitor progress to ensure timely completion. - Lead the development of new formulations by investigating API characteristics, safety, and compatibility with other ingredients, conducting necessary testing, and scaling up studies. - Identify resource requirements, including materials, manpower, and machinery, and utilize literature information effectively throughout development. - Develop R&D plans and experimental designs using QBD principles, analyze data, draw conclusions, and make recommendations for product development. - Coordinate lab scale-up and pilot BE batches, ensuring adherence to lab GMP practices. - Review lab experiment notebooks and technology transfer documents promptly. - Liaise with technology transfer and production teams for seamless technology transfer and review batch manufacturing and process validation documents. - Optimize existing product performance by researching API characteristics and formulas. - Monitor stability studies, interpret results, and advance product development accordingly. - Coordinate with various departments to ensure timely project completion. - Prepare departmental SOPs, manuals, and guidelines as required. - Monitor machine IQ, OQ, and PQ activities, ensuring proper functioning and maintenance. - Provide training to subordinates, technicians, and housekeeping personnel on equipment and systems. - Manage storage and destruction of raw materials and finished goods and maintain RLD samples inventory. - Participate in audits and ensure compliance with recommendations. - Stay updated with the latest developments in technology, conceptual thinking, and communication skills. Qualifications & Pre-Requisites: - Master's in Pharmacy (Pharmaceutics). - Must-Have Skills: Formulation development experience in Solid & Liquid Oral; Pellets project experience preferred. Additional Company Details: - The role may require working extended hours or shifts based on requirements. - Visits to manufacturing sites may be necessary. (Note: The additional notes section has been included as an "Additional Company Details" paragraph in the final JD),
Role Overview: As a QC Team Leader at our company located in Ambernath, Maharashtra, your primary responsibility will be to lead a team of 30+ members in the QC-AMV team, including LC-MS, Nasal, and FT-NIR teams, for regular testing and method validation activities. You will also provide backup support to the QC Head of Department (HOD) by managing daily updates, commercial output, monthly sample status, training, review meetings, and coordination with stakeholders to align work requirements. Your role will involve executing and approving various types of Quality Management System (QMS) processes, identifying scientific root causes, implementing corrective and preventive actions (CAPA), and ensuring laboratory compliance. Key Responsibilities: - Lead the QC-AMV team for regular testing and method validation activities with analytical knowledge and leadership qualities to achieve company goals. - Support the QC HOD with daily updates, commercial output, monthly sample status, training, review meetings, and stakeholder coordination. - Execute and approve different QMS processes, identify root causes, implement CAPA, and maintain lab compliance. - Design and execute analysis planning, data interpretation, and presentation to the HOD. - Provide guidance to team members, monitor key performance indicators, and lead QC-AMV work in the absence of the QC HOD. - Collaborate with cross-functional teams, stay updated on industry trends, and ensure compliance with GLP and health, safety, environmental systems. - Manage work in all shifts and travel to other sites as per company policy. Qualifications Required: - Master's degree in Science or Bachelor's/Master's in Pharma. - Strong analytical knowledge and expertise in modern analytical instruments (HPLC, GC, LC-MS, NIR, Nasal performance testing). - Work experience in QC, AMV, and AD departments. - Leadership skills, problem-solving abilities, strategic mindset, organizational skills. - Knowledge of Chromeleon 7.2 and Sciex software is advantageous. - Experience in GMP, USFDA/EU audits. - Excellent communication skills. (Note: Additional details about the company were not included in the provided job description.),
Company Overview: Rubicon Research Limited is a fast-growing pharmaceutical formulation company delivering value to our customers and investors by developing, manufacturing, and marketing branded specialty and generic prescription pharmaceutical products in regulated markets. Our product portfolio comprises over 250 SKUs across more than 70 product families. We have an established marketing, sales, and distribution platform in the US through our subsidiaries AdvaGen Pharma which markets non-branded prescription products, and Validus Pharmaceuticals which markets branded prescription products and promotes them to healthcare practitioners in the US. We have two US FDA-inspected R&D facilities – one each in India and Canada, and two manufacturing facilities in Maharashtra, India with multiple accreditations from multiple regulatory agencies such as US FDA, Food and Drugs Administration, Maharashtra (WHO-GMP accreditation) and Health Canada. Our facilities are equipped with various drug development and manufacturing capabilities across dosage forms. Headquartered in Thane, India we have a sales and marketing office in New Jersey, USA. For additional information visit www.rubicon.co.in Position Overview: To manage and deliver digitization projects in the area of Finance. Key Responsibilities: To lead digitization projects by Preparation of project charter with scope, project timeline, effort estimates, governance structure, RACI & success criteria Business Process Optimization and Best Practices To prepare business requirements for current and future with a view to realizing business benefits. Vendor / solution evaluation for digitization projects Configure of SAP FICO module Ensure seamless integration with other SAP modules / non-SAP systems Troubleshoot and resolve SAP Modules related issues and enhancements Support data migration, master data management, Functional Testing and system testing Design learning programs for business on End user training, SAP best standards and technologies. Collaborate with cross-functional teams to ensure smooth system operations Participate in SAP upgrades, patching, and S/4HANA migration projects as needed Ensure effective change management Ensure minimal customization in standard processes. Sort out day-to-day queries of end users. SAP License/User Management To participate in the SAP audits for closure Ensure adherence to safety / compliance guidelines. Maintain Confidentiality, Integrity, and Availability of Company Information. Ensure adherence of organization Information security policy and guidelines. Attend Information Security trainings, awareness sessions and e-learning course. Key Qualifications & Experience: MBA – Finance Good understanding on business processes and hands on experience in SAP FICO
Company Overview: Rubicon Research Limited is a fast-growing pharmaceutical formulation company delivering value to our customers and investors by developing, manufacturing, and marketing branded specialty and generic prescription pharmaceutical products in regulated markets. Our product portfolio comprises over 250 SKUs across more than 70 product families. We have an established marketing, sales, and distribution platform in the US through our subsidiaries AdvaGen Pharma which markets non-branded prescription products, and Validus Pharmaceuticals which markets branded prescription products and promotes them to healthcare practitioners in the US. We have two US FDA-inspected R&D facilities one each in India and Canada, and two manufacturing facilities in Maharashtra, India with multiple accreditations from multiple regulatory agencies such as US FDA, Food and Drugs Administration, Maharashtra (WHO-GMP accreditation) and Health Canada. Our facilities are equipped with various drug development and manufacturing capabilities across dosage forms. Headquartered in Thane, India we have a sales and marketing office in New Jersey, USA. For additional information visit www.rubicon.co.in Position Overview: To manage and deliver digitization projects in the area of Finance. Key Responsibilities: To lead digitization projects by Preparation of project charter with scope, project timeline, effort estimates, governance structure, RACI & success criteria Business Process Optimization and Best Practices To prepare business requirements for current and future with a view to realizing business benefits. Vendor / solution evaluation for digitization projects Configure of SAP FICO module Ensure seamless integration with other SAP modules / non-SAP systems Troubleshoot and resolve SAP Modules related issues and enhancements Support data migration, master data management, Functional Testing and system testing Design learning programs for business on End user training, SAP best standards and technologies. Collaborate with cross-functional teams to ensure smooth system operations Participate in SAP upgrades, patching, and S/4HANA migration projects as needed Ensure effective change management Ensure minimal customization in standard processes. Sort out day-to-day queries of end users. SAP License/User Management To participate in the SAP audits for closure Ensure adherence to safety / compliance guidelines. Maintain Confidentiality, Integrity, and Availability of Company Information. Ensure adherence of organization Information security policy and guidelines. Attend Information Security trainings, awareness sessions and e-learning course. Key Qualifications & Experience: MBA Finance Good understanding on business processes and hands on experience in SAP FICO