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, 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 assist in supporting the end-to-end packaging development, cost improvement as well as process improvement program.

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**
- Must possess a Degree in Pharmacy, Packaging, Technology Transfer, or equivalent. Having Master's, MBA, or PHD would be considered a vital asset.
- Has knowledge of pharma packaging requirements and cGMP requirements.
- Understanding of Pharma packaging components, packaging process, packaging equipment and packaging analytical testing.
- Proficient in Microsoft Office Suite.
- Must be willing to work at Bandar Baru Enstek, Negeri Sembilan.

Pay: RM2,800.00 - RM3,800.00 per month

Schedule:

- Monday to Friday

Application Question(s):

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

**Education**:

- Bachelor's (preferred)

Work Location: In person

Expected Start Date: 04/07/2025