Manager Outsourcing Pharmaceutical R&D

Duopharma Biotech Bhd Group of Companies.; Shah Alam; On-site; MYR 200,000 - 320,000; Full time

Job summary

Duopharma Innovation Sdn. Bhd. is seeking an experienced Manager, Outsource R&D to lead outsourced pharmaceutical development projects and external partnerships.

You will oversee CDMO/CMO collaborations, technology transfer, and commercialization support for Duopharma's pharmaceutical and consumer healthcare products. The role requires a strategic mindset with 10+ years in pharmaceutical R&D, strong project management, and deep GMP/regulatory knowledge.

Qualifications

• Bachelor's Degree in Pharmacy, Pharmaceutical Sciences, or related discipline.
• Minimum 10 years of experience in Pharmaceutical R&D.
• Experience managing outsourced R&D, technology transfer, and external partnerships.

Responsibilities

• Lead outsourced R&D and contract development projects with external partners.
• Drive technology transfer to ensure successful commercial production.
• Manage cross-functional teams and external collaborations across CDMOs/CMOs/CROs.

Skills

R&D leadership

CDMO/CMO management

Technology transfer

Project management

Stakeholder management

Education

Bachelor's Degree in Pharmacy

Job description

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

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

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.

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.
• 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.

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.

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.
• 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.

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.

Duopharma Biotech Berhad began with the establishment of Duopharma (M) Sdn Bhd in 1978. Incorporated in 2000, we are one of Malaysia’s leading pharmaceutical companies listed on the Bursa Malaysia’s Main Market. We specialise in manufacturing, R&D, and marketing of generic drugs and consumer healthcare products (CHAMPS®, FLAVETTES® & UPHAMOL) as well as biosimilars (ERYSAA®, Basalog One®). As a pioneer in halal pharmaceuticals, we were the 1st to receive JAKIM certification for OTC and prescription products under MS2424:2019. Headquartered in Kuala Lumpur, we operate three GMP-certified plants (Klang, Bangi & Glenmarie) and have a growing presence in Indonesia, the Philippines and Singapore.

Duopharma Biotech Berhad began with the establishment of Duopharma (M) Sdn Bhd in 1978. Incorporated in 2000, we are one of Malaysia’s leading pharmaceutical companies listed on the Bursa Malaysia’s Main Market. We specialise in manufacturing, R&D, and marketing of generic drugs and consumer healthcare products (CHAMPS®, FLAVETTES® & UPHAMOL) as well as biosimilars (ERYSAA®, Basalog One®). As a pioneer in halal pharmaceuticals, we were the 1st to receive JAKIM certification for OTC and prescription products under MS2424:2019. Headquartered in Kuala Lumpur, we operate three GMP-certified plants (Klang, Bangi & Glenmarie) and have a growing presence in Indonesia, the Philippines and Singapore.