Associate Executive, Technology Transfer

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

The Associate Executive, Technology Transfer is responsible to support the execution of technology transfer activities by preparing and reviewing technical documents, assisting in scale-up and validation, and collaborating across functions, ensuring data integrity and compliance with cGMP in pharmaceutical manufacturing. Senior roles will provide more strategic input and independently manage product portfolios or projects.

Key Responsibilities:-

• Generate core technology transfer documentation including the Technology Transfer Checklist, Feasibility Study Plans, Technology Transfer Report, New Production Introduction Form, Compilation of pilot, scale up and exhibit batch data.
• Preparation of documents like SOPs, Sampling Protocols, Scale up batch protocols and related reports, Change control documentation, Risk assessments etc.
• Planning the batch sizes for process optimization/scale up and exhibit batches to meet the equipment capacities and regulatory requirements.
• Collaborate with cross-functional stakeholders—including R&D, Quality and Technical Ops teams—to facilitate seamless technology transfer and support product lifecycle management.
• Execution and data monitoring of Trial, Pilot/ Scale up, Hold Time, Exhibit, and Process Validation product batches at respective manufacturing sites
• Implementing the process optimization/scale up protocols and data generated during optimization/scale up and exhibit batches.
• Work in association with Product Development to facilitate manufacturing validation of new products and processes.
• Attend pre-GMP batches at Novugen R&D or CDO/CMO sites on an as-needed basis.
• Provide support for the technology transfer activity from Novugen Manufacturing to CMO sites.
• Review and support team for documents such as Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs) and Scale Up reports.
• Ensure robustness and capability of commercial manufacturing and packaging processes by monitoring of Critical Process Parameters (CPP) and Critical Quality Attributes (CQAs) through a continued process verification program and review of Annual Product Reviews (APRs)/Product Quality Reviews (PQRs) for selected products based on inputs of appropriate stake holders.
• Ensures adherence to cGMP requirements, Guidelines, SOPs.
• Any other ad hoc tasks assigned by the management

About you

• Must possess a Bachelor's Degree in Pharmaceutical Sciences, Chemical Engineering, Biotechnology, Industrial Pharmacy or equivalent.
• 0-3 years related experience in Pharma, FMCG, and Healthcare industries.
• Candidates with prior internships or academic research in formulation development, process scale-up, or cGMP environments preferred
• Proven track record in end-to-end technology transfer, including direct involvement in process development, site transfer, regulatory documentation, and cross-functional coordination
• Technically apt on technology transfer lifecycle and scale-up principles, process validation (PV), equipment qualification (IQ/OQ/PQ), and analytical method transfer
• Exposure to ICH, WHO, EMA, and USFDA guidelines relevant to product transfers and validation
• Proficient in interpreting batch manufacturing records (BMRs), process flow diagrams (PFDs), risk assessments, and change control documentation
• Skilled in compiling and reviewing Technology Transfer Protocols, Feasibility Reports, Sampling Plans, and Process Summary Reports
• Familiarity with cGMP, GLP, GDP, and other applicable global regulatory standards
• Good scientific reasoning, data analysis, project management and technical writing skills
• Strong intrapreneurial skills and mindset from start up to established organization.
• Versatile, meticulous and resilient, ability to multitask and stay positive in high-pressure ambiguous environments and work towards delivering results
• Proficient in Microsoft Office Suite
• Proficient in using software/tools relevant to the pharmaceutical or healthcare industry etc
• Willingness to travel to manufacturing or partner sites as needed

Job Type: Full-time

Pay: RM2, RM3,000.00 per month

Application Question(s):

• Have you been involved in any technology transfer, process improvement, or project coordination tasks? (Yes/No)

If yes, please explain your role.

• Are you familiar with preparing or reviewing technical documents (e.g., SOPs, batch records, reports)? (Yes/No)
• Do you have basic knowledge of GMP or regulatory requirements? (Yes/No)
• What is your expected salary?
• How long your notice period?

Work Location: In person