全职 Executive, Technology Transfer (R-D) 工作, 薪水 up to MYR 3,500, Novugen Pharma Selangor 公司招聘中 - Ricebowl

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, impact lives across the world.

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

About the role

The Executive, Technology Transfer will support end-to-end technology transfer activities, including process scale-up, process validation, manufacturing readiness, product commercialization, and continuous improvement initiatives to ensure successful transfer of products into commercial manufacturing.

Key Responsibilities:-

• Generate key documentation including the Technology Transfer Checklist, Technology Transfer Master Plan/Scope, Technology Transfer Report, compilation of scale up and exhibit batch data.
• Planning the batch sizes for process optimization/scale-up and exhibit batches to meet the equipment capacities and regulatory requirements.
• Execution for Scale Up, Exhibit, Process Validation batches and provide technical support to cross functional teams.
• Implementing the process optimization/scale-up protocols and data generated during optimization/scale-up and exhibit batches.
• Preparation of documents like SOP, Sampling Protocol, scale-up batch protocol and Report for the scale up batches, Change control, Risk assessment etc.
• 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 site on an as-needed basis.
• Provide support for the technology transfer activity from Novugen Manufacturing to CMO site.
• Review and support team for documents such as BMRs, BPRs, and Scale Up reports.
• Ensure robustness and capability of commercial manufacturing and packaging processes by monitoring 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 and SOPs.

About you

• Bachelor’s Degree in Pharmacy, Pharmaceutical Sciences, Chemical Engineering, Life Sciences, or equivalent.
• Preferably with at least 2 years of relevant experience in Technology Transfer, Manufacturing, Process Validation, Product Development, or related functions within the Pharmaceutical, Healthcare, or FMCG industries.
• Knowledge of cGMP requirements, pharmaceutical manufacturing processes, and regulatory compliance.
• Understanding of technology transfer activities, scale-up processes, process validation, process optimization, and product lifecycle management.
• Exposure to cross-functional collaboration involving Production, Quality Assurance, Quality Control, Regulatory Affairs, and R&D teams.
• Strong project coordination, problem-solving, and communication skills.
• Proficient in Microsoft Office Suite.
• Must be willing to work at Bandar Baru Enstek, Negeri Sembilan.

Job Type: Full-time

Pay: From RM3,500.00 per month

Application Question(s):

• How long is your notice period?
• How much is your expected salary?

Education:

• Bachelor's (Preferred)

Work Location: In person