Executive/Senior Executive, Analytical

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 Executive/Senior Executive, Analytical will oversee Analytical method development, analytical support to the Formulation development, as well as technology transfer activities.

Key Responsibilities: -

• Shall carry out stability testing & routine testing of drug product, comparative dissolution profiles ensuring delivery in accordance with project timelines.
• Shall execute Assay & Dissolution methods development for drug substances.
• Shall perform validation of analytical methods.
• Shall qualify or prepare working standards as per the requirement.
• Shall prepare relevant dossier documents.
• Generation of data to complete dossier submission such as stability, genotoxic impurities, physical properties, additional studies, comparative dissolution profiles etc.
• Online documentation of raw data, entries of logbooks and system calibrations in time, ensure compliance to SOPs, GLP and Good documentation practices.
• Should be flexible to align self-plan with dynamic timelines and project's need.
• Maintain instruments and the respective calibrations / performance verifications as per defined schedules.
• Working standards and impurity standards management and column management.
• Ensuring good relation and communication with all members of the internal and external teams.
• Shall maintain good laboratory practices as per Novugen guidelines.
• Shall follow data integrity policies strictly to maintain the compliance.
• Shall undergo or complete necessary GXP trainings as per the schedule.
• Shall complete the necessary SOP trainings mandatorily.
• Ensuring lab cleanliness and personal safety and lab safety.

About you

• 3-5 years related experience from Pharma, FMCG, and Healthcare industries.
• Proficient in Analytical development technologies is added advantage.
• Strong industry-academia fraternity and business acumen to promote new technologies.
• Strong intrapreneurial skills and mindset from start up to established organization.
• Proficient in Microsoft office Suite
• Proficient in using software/tools relevant to the pharmaceutical or healthcare industry etc