Manager Outsourcing Pharmaceutical R&D

Manager, Outsource R&D (Pharmaceutical Development & Technology Transfer)

Location: Glenmarie, Selangor
Company: Duopharma Innovation Sdn. Bhd.

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Job Summary

We are seeking an experienced and strategic R&D professional to lead outsourced pharmaceutical development projects and external innovation partnerships. This role is responsible for managing new product development, contract development and manufacturing (CDMO/CMO), technology transfer, and commercialization activities to support Duopharma's pharmaceutical and consumer healthcare product pipeline.

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Key Responsibilities

External R&D & New Product Development

• Lead outsourced R&D and contract development projects to deliver a robust pipeline of pharmaceutical and consumer healthcare products.
• Develop and execute external R&D strategies that support innovation, business growth, and product commercialization.
• Drive new product development initiatives from concept through technology transfer and commercial manufacturing.
• Manage multiple projects simultaneously, ensuring timely delivery within approved scope, budget, and quality standards.

Strategic Partnership & Vendor Management

• Identify, evaluate, and establish strategic partnerships with Contract Development and Manufacturing Organizations (CDMOs), Contract Manufacturing Organizations (CMOs), Contract Research Organizations (CROs), universities, and other external partners.
• Lead technical due diligence, partner qualification, and feasibility assessments to ensure alignment with business objectives.
• Negotiate and manage technical and commercial agreements, including Non-Disclosure Agreements (NDAs), Contract Manufacturing Agreements (CMAs), and Quality Technical Agreements (QTAs).
• Build and maintain strong relationships with external collaborators and key stakeholders.

Technology Transfer & Commercialization

• Lead technology transfer activities between external partners and Duopharma manufacturing sites to ensure successful commercial production.
• Collaborate closely with Manufacturing, Quality Assurance, Validation, Engineering, and Regulatory Affairs to support product scale-up and launch.
• Ensure product development activities comply with GMP, regulatory requirements, and company quality standards.
• Support product registration activities by coordinating technical documentation and regulatory submissions.

Project Management & Cross-Functional Collaboration

• Lead cross-functional project teams to achieve project milestones, timelines, and deliverables.
• Monitor project budgets, resources, risks, and performance while implementing appropriate mitigation strategies.
• Coordinate DART meetings for Consumer Healthcare projects and ensure project decisions, action plans, and meeting outcomes are documented.
• Work closely with Commercial, Procurement, Finance, Legal, Quality, Manufacturing, and Regulatory Affairs teams throughout the product development lifecycle.

Innovation & Team Leadership

• Drive continuous improvement and innovation initiatives within the External R&D function.
• Support intellectual property activities, including patent assessments and Freedom-to-Operate (FTO) evaluations where applicable.
• Lead, coach, and develop team members while fostering a collaborative, high-performance working environment.
• Promote knowledge sharing and best practices across the R&D organization.

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Requirements

Qualifications

• Bachelor's Degree in Pharmacy, Pharmaceutical Sciences, or a related discipline.

Experience

• Minimum 10 years of experience in Pharmaceutical Research & Development.
• Proven experience managing outsourced R&D, technology transfer, CDMO/CMO partnerships, or pharmaceutical product development.
• Experience in project management, product commercialization, and cross-functional leadership is highly desirable.

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Technical Skills & Knowledge

• Strong knowledge of pharmaceutical product development and manufacturing processes.
• Experience in technology transfer, CDMO/CMO management, and project management.
• Good understanding of GMP, regulatory requirements, and quality management systems.
• Knowledge of risk management, technical due diligence, and commercialization strategies.
• Excellent negotiation, stakeholder management, and communication skills.

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Leadership Competencies

• Strategic thinker with strong business and commercial acumen.
• Excellent leadership and people development skills.
• Strong analytical, problem-solving, and decision-making abilities.
• Highly organised with the ability to manage multiple complex projects.
• Results-oriented with a strong focus on innovation, collaboration, and continuous improvement.

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Why Join Us?

• Lead strategic pharmaceutical innovation and external R&D partnerships.
• Drive technology transfer and commercialization of new pharmaceutical and consumer healthcare products.
• Collaborate with global CDMOs, CROs, universities, and industry partners.
• Play a key role in shaping Duopharma's future product pipeline and innovation strategy.