Executive, Analytical (R&D)

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 eight 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 the 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, 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

• Must possess a Degree in Pharmacy, or equivalent.
• Minimum 3 years related experience from Pharma, FMCG, and Healthcare industries
• A proactive and curious mindset with the ability to question, explore, and improve analytical approaches.
• 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

Job Types: Full-time, Permanent

Pay: From RM3,000.00 per month

Benefits:

• Free parking
• Health insurance

Application Question(s):

• Please state your notice period duration in months
• Please state your expected salary (RM).

Experience:

• method development: 3 years (Required)
• analytical testing: 3 years (Preferred)
• pharmaceutical : 3 years (Preferred)

Work Location: In person