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Manager- Strategic sourcing

4 weeks ago

Thane, India Rubicon Research Limited Full time

About Rubicon ResearchRubicon 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.inPosition Title: Manager, Strategic sourcing - Active Pharmaceutical Ingredients (API)Type: Full timeLocation: Thane, Maharashtra.Position Overview:We are seeking an experienced Procurement Manager with a strong technical background in Active Pharmaceutical Ingredients (API) to drive strategic sourcing and supplier management for our organization. The ideal candidate will have expertise in evaluating APIs based on their technical characteristics (including KSMs, impurity profiles, and backward integration), regulatory aspects, and the ability to assess and manage DMF changes. This role requires the negotiation of prices based on technical evaluations, managing supplier relationships to identify potential risks, and suggesting a portfolio based on supplier interactions. Additionally, the role will involve identifying and developing new vendors, including co-development opportunities.Key Responsibilities:Technical Evaluation & Sourcing:- Evaluate APIs of suppliers based on technical criteria, including Key Starting Materials (KSMs), impurity profiles, and backward integration.- Assess supplier basis the robustness of the API manufacturing process, focusing on consistency and scalability.- Ensure that the suppliers of APIs meet the necessary specifications for quality and regulatory compliance, including potential nitrosamine risk assessments.Regulatory Compliance & DMF Evaluation:- Collaborate with Regulatory Affairs to evaluate and review DMFs (Drug Master Files), ensuring suppliers are up to date and compliant with regulatory agencies (FDA, EMA, etc.).- Assess any changes to DMFs and evaluate their impact on the overall quality and regulatory approval process.- Work closely with suppliers to ensure timely submission of necessary documents and certifications required for regulatory approvals.Price Negotiation & Cost Optimization:- Negotiate pricing with suppliers based on the technical evaluation of the APIs, ensuring cost-effectiveness without compromising on quality and regulatory compliance.- Leverage technical expertise to identify opportunities for cost savings and more favorable pricing structures.Supplier Relationship Management:- Build and maintain strong, long-term relationships with API suppliers, ensuring continuous alignment with company goals and compliance requirements.- Monitor supplier performance and proactively identify any risks related to supply chain disruptions, quality issues, or regulatory challenges.- Collaborate with suppliers to identify and resolve potential issues before they impact project timelines or regulatory approvals.Portfolio Development & Vendor Management:- Suggest an optimal API portfolio based on vendor interactions and technical evaluations, aligning with company needs and regulatory standards.- Identify new suppliers and co-development opportunities to support strategic objectives and ensure a diversified and resilient supplier base.- Develop and qualify new vendors for APIs of interest, ensuring they meet the company’s quality and regulatory standards.Cross-functional Collaboration:- Work closely with internal stakeholders, including R&D, Quality Assurance, Regulatory Affairs, and Production teams, to ensure smooth execution of procurement projects.- Ensure that API procurement timelines align with project schedules and production requirements, minimizing any delays or disruptions.Risk Management & Market Analysis:- Assess potential risks associated with API sourcing, including regulatory, supply chain, and geopolitical factors.- Provide insights into market trends, competitor activities, and industry developments that could affect API procurement strategies.Qualifications and Skills:Educational Requirements:- M.Sc. in Analytical Chemistry, Inorganic Chemistry, or Pharmaceutical Sciences (MPharm) with a focus on analytical chemistry. PhD is also acceptable.Experience:- 5-7 years of experience in the pharmaceutical industry, with a strong background in API sourcing, technical customer service, or business development (BD) related to APIs. Experience in evaluating DMF changes and assessing regulatory compliance for APIs. Knowledge of API manufacturing processes, impurity profiles, and backward integration. Familiarity with nitrosamine risk assessments and their impact on regulatory submissions.Key Skills:- Strong understanding of API technical and regulatory aspects, including KSMs, impurity profiles, and regulatory requirements. Ability to negotiate and manage supplier contracts, with a keen focus on pricing and technical evaluations. Excellent relationship management skills with the ability to identify and address potential risks. Strong communication skills to work with internal stakeholders and suppliers effectively. Analytical mindset to assess technical, regulatory, and commercial aspects of APIs. Familiarity with strategic sourcing, market analysis, and supplier qualification processes.Certifications:- Certification in Supply Chain Management or Procurement (CIPS, CPSM) is a plus.- Understanding of GMP (Good Manufacturing Practices) and ICH (International Council for Harmonisation) guidelines.