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 Senior Manager, Formulation will oversee Formulation Development team and optimizing drug formulations that meet regulatory standards, ensure product stability and enhance therapeutic effectiveness. Role will be expanded to be subject matter expertise in Biopharmaceutics and PK, PBBM Modelling, Biostatistics and simulations, formulation aspects that could affect BA/BE, various guidance related to BA/BE and biowaiver from various regulatory agencies.
Key Responsibilities: -
- Lead and oversee Formulation function including planning, troubleshooting, and technical support in R&D and commercial launches.
- Deep exposure to develop difficult Oral Solid formulations for US / EU market - Extended-Release Pellets in tablets, DR/SR capsule, MUPS tablets, OCAS tablets, etc.
- Development and implementation of the formulation strategies for product development to global markets. Evaluation of technical feasibility of future pipeline products.
- Designing Bioequivalence studies to ensure they pass in the first attempt.
- Development and identification of bio-relevant and discriminatory dissolution media by in depth evaluation of formulation composition and process of manufacturing.
- Evaluation of pilot BE results and finalization of design and subjects for pivotal BE studies.
- Assessing the complexity of products in terms of achieving bioequivalence.
- Drafting bio-strategies (alternative to formulation and study design) to achieve bio-success.
- Formulation development and characterization for potential drug delivery systems and platforms.
- Execution of Pre-formulation, Compatibility studies, Selection of the container closure system, Selection of processing Aids/components, Lab Scale stability studies, and process development.
- Thorough technical review of QbD requirements for the formulation sections as well as compiled dossiers, which shall include (but are not limited to) QTPP, CQA, CMA, CPP, etc.
- Writing /reviewing of standard operating procedure (SOPs), Specifications, standard test procedure for drug substance & drug product.
- Writing and reviewing critical sections of regulatory file/dossier: coordination for the acquisition of applicable data; drafts and submits the regulatory team.
- Successful Scale-up, approval, and commercialization of products (Pellets formulations, IR, ER Tablets, and etc) for global markets.
- Matrix tablet, Pellets, Wurster technology, Roller compactor, Extrusion-spheronization, Fette/GEA tablet press, Scale-up calculation, etc.
- Observing and complying with Good laboratory practice, with required documentation, implementing related SOP in the lab.
- Documentation of MFR, PDR, compilation, and Interpretation of Analytical data.
- Collaborate closely with CFT to ensure all development activities are in accordance with the latest guidelines and within timelines.
- To work with CFTs on financial forecasts and budgets as & when required.
- Lead technical inputs for investigations and regulatory inspections.
- Collaborate with Process Development and Manufacturing teams to support process optimization, capacity improvement, and scale-up activities.
- Manage, coach, mentor, and motivate employees for outstanding performance.
- Efficiently represent the formulation development function at all cross-department and leadership meetings.
About You
- Must possess a Degree in Pharmacy, Chemical Sciences or equivalent. Having Masters, MBA or PHD would be considered a vital asset.
- Minimum 15 - 20 years related experience from Pharma, FMCG, and Healthcare industries.
- Thorough understanding and demonstrated ability in product development for regulated & semi-regulated markets
- Detailed understanding of regulatory guidelines/regulations for successful dossier preparation, submission of Generic products in US, EU and /or global markets
- Sound understanding of pharmacokinetics & biopharmaceutical aspects of product development
- Consistent record of delivering formulations by initiating and developing a perfect in-vitro tool to predict the in-vivo behaviour of the molecules/formulation under development
- Proficient in using software / tools relevant to pharmaceutical or healthcare industry etc.
- Scientific rigor, attention to detail / meticulous
- Excellent mentoring, coaching and people management skills
- Strong intrapreneurial skills and mindset from start up to established organization
- Versatile and resilient, ability to stay positive in high-pressure and ambiguous environments and work towards delivering results
