Kerja Sepenuh Masa, Manager, Technology Transfer di Novugen Negeri Sembilan - Maukerja

About Us

Novugen is a wholly owned subsidiary of SciTech International, a UAE-based group with over 30 years of experience in the healthcare industry. We specialize in venturing into strategic healthcare businesses and developing world-class healthcare facilities across the globe. With operations in multiple countries across continents, our global presence and expertise empower us to meet the complex challenges of delivering hard-to-source, technology-intensive pharmaceutical products to market.

Our manufacturing facilities in Bandar Enstek, Negeri Sembilan, are the first USFDA-approved pharmaceutical manufacturing facilities in Malaysia and Southeast Asia. We are also the first pharmaceutical company in the region to be vertically integrated from R&D to manufacturing, giving us greater control over the supply chain and reflecting our commitment to meeting a wide range of stringent regulatory standards.

At Novugen, we are united by a shared vision, with a team of talented individuals from diverse backgrounds and nationalities working together towards one common goal. We are driven by a passion for science and innovation, striving to accelerate the launch of pharmaceuticals that lack robust generic alternatives due to their complexity. Our continued investment in R&D and dedication to excellence aim to provide early access to affordable, high-quality medicines, impacting lives across the world.

Together, we are shaping the future of healthcare and changing lives everywhere.

About the Role

We are hiring a Technology Transfer professional to lead the successful transfer of products from development to commercial manufacturing. The role will work closely with Formulation R&D, Manufacturing, Quality, Regulatory Affairs, Supply Chain, Packaging, and Commercial teams to ensure smooth scale-up, robust processes, and timely product launches.

The ideal candidate will combine strong technology transfer experience with sound statistical analysis skills, product lifecycle management exposure, and a practical mindset for process improvement, simplification, and continuous improvement.

Key Responsibilities:

• Lead technology transfer activities from development batches through scale-up, validation, and commercial manufacturing.
• Prepare, review, and coordinate transfer protocols, batch records, validation support documents, risk assessments, and technical reports.
• Use statistical tools to assess process capability, variability, trends, deviations, and critical process or quality parameters.
• Work with cross-functional teams to resolve technical issues, support investigations, and ensure manufacturing readiness.
• Drive product lifecycle management activities, including process optimization, robustness improvement, post-approval changes, and continued process verification.
• Identify opportunities to simplify processes, reduce complexity, improve efficiency, and standardize ways of working.
• Provide technical guidance, training, troubleshooting support, and knowledge transfer to manufacturing sites.
• Ensure compliance with cGMP, quality systems, regulatory expectations, safety requirements, and agreed project timelines.

About You

• Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemical Engineering, Process Engineering, or a related discipline.
• Experience in pharmaceutical technology transfer, formulation development, scale-up, process validation, or manufacturing technical support.
• Strong understanding of QbD, DoE, process capability, trend analysis, statistical interpretation, and data-driven decision-making.
• Experience with product lifecycle management, post-approval changes, continued process verification, and process improvement initiatives.
• Working knowledge of cGMP, ICH guidelines, regulatory filing requirements, deviation/CAPA systems, and change control processes.
• Ability to convert technical data into clear recommendations, practical actions, and well-structured documentation.
• Strong communication, collaboration, project coordination, and stakeholder management skills.
• Continuous improvement mindset with focus on simplification, standardization, and practical problem solving.
• Experience with oral solid dosage forms or other regulated pharmaceutical manufacturing environments.
• Hands-on use of statistical software, data visualization tools, or advanced Excel-based analysis.
• Experience working across multiple sites, functions, and cultures.
• Ability to balance compliance, speed, risk management, manufacturability, and business priorities.