Senior Executive/Assistant Manager, Formulation

About us

Novugen is a wholly owned subsidiary company of a UAE-based group, SciTech International. With over 30 years of experience in the healthcare industry, the company is equipped with vast experience in venturing into strategic healthcare businesses and development of world-class healthcare facilities around the globe. We bring hard-to-source and technology intensive products to the market.

Our manufacturing facility in Bandar Enstek, Negeri Sembilan is the FIRST USFDA approved pharmaceutical manufacturing facility in Malaysia and the only in Southeast Asia. We are also the first pharmaceutical company in the region to be vertically integrated from API to Finished Products R&D and manufacturing.

The people behind Novugen are professionals coming from diverse backgrounds and nationalities from all over the world, working together to achieve one common goal. We strive to innovate new concepts to accelerate the launch of pharmaceuticals that lack robust generic alternatives due to their complexity.

Our vision is to be the largest and fastest growing pharmaceutical company in Southeast Asia by 2025, competing in global markets. Through our passionate teams and continuous investment in R&D, we aim to provide early access to affordable medicine of the highest quality. This is our commitment to change lives worldwide.

About the role

The incumbent will oversee the formulation development of oral solid dosage forms for regulated and semi regulated markets. Also, ensuring the quality, safety and efficacy of Novugen products. The incumbent will collaborate with team members, cross-functional teams and lead projects with the supervision of managers, contributing to the innovation and growth of Novugen.

Key Responsibilities:

• Literature survey, Patent search, online documentation, design, development & execution of developmental batches of new products.
• Preparation of Product Development Plans (PDP), Stability compilations, Product Development Reports, & various other technical documents for regulatory submission.
• Interpretation of analytical results & grounding decision-based activities for product development with consent of Manager.
• Execute trial batches of formulation development of tablets, capsules, for global filings following QbD approach.
• Handling of statistical software for design of experiments (DoE)
• Preparation of specifications, batch records, & other miscellaneous protocols to undertake studies for regulatory submission.
• Preparation of reports, spread sheets, and all summary documents for successful multi-product pre-approval inspection of regulatory bodies.
• Identification and optimization of critical process parameters and execution of exhibit batches for global market in GMP areas.
• Contribution to process development of critical products with technical difficulties for filings, especially due to scale dependent parameters of process.
• Planning & execution of batches for cost reduction, vendor addition, SUPAC changes, scale ups & other process challenge studies for improvising productivity & simplification of operations.
• Technical trouble shooting at shop floor during scale-up & commercial manufacture.
• Any other ad hoc tasks assigned by the management

About you

• Must possess a Degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering or equivalent.
• Minimum 3-5 years related experience from Pharma, FMCG, and Healthcare industries
• Proficient in formulation development technologies is an advantage.
• Proficient in Project Management Methodologies is an advantage.
• Proficient in Microsoft Office Suite.
• Proficient in using systems / software / tools relevant to pharmaceutical or healthcare industry etc.
• Scientific rigor, attention to detail / meticulous.
• 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.

Job Type: Full-time

Pay: RM4, RM6,000.00 per month

Benefits:

• Maternity leave
• Professional development

Application Question(s):

• Please state you notice period.
• Please state your expected salary.

Experience:

• OSD Formulation & Development: 3 years (Required)

Work Location: In person