Associate Manager, Formulation (R&D)

NOVUGEN PHARMA (MALAYSIA) SDN. BHD.; Shah Alam; On-site; MYR 180,000 - 240,000; Full time

Job summary

NOVUGEN PHARMA (MALAYSIA) SDN. BHD. is seeking an Associate Manager, Formulation to lead a team of scientists in developing oral solid dosage forms for regulated and semi-regulated markets.

You will guide development programs, ensure regulatory readiness, and drive cross-functional collaboration. The role emphasizes QbD-based development, literature surveys, technology transfer, and strong interaction with Management to advance innovative products while ensuring GMP compliance and timely

Qualifications

• 6–10 years of pharma experience with OSD formulation.
• 2–3 years of supervisory experience.
• Experience developing formulations for regulated & semi-regulated markets.
• Understanding regulatory guidelines for dossier preparation and submission in US, EU and global markets.
• Knowledge of pharmacokinetics & biopharmaceutical aspects of product development.
• Strong project management skills.
• Proficient with Microsoft Office and pharma systems.
• Ability to work under pressure and manage stakeholders.

Responsibilities

• Supervise and lead a team of formulation scientists and lab technicians, providing coaching and mentoring.
• Oversee literature survey, patent search, online documentation, design, development & execution of developmental batches.
• Prepare Product Development Plans (PDP), Stability compilations, and Product Development Reports for regulatory submission.
• Review analytical results and guide decision-making for product development with minimal supervision.
• Review trial batches for tablets, capsules & other solid oral dosage forms for global filings following QbD.
• Support process development and technology transfer activities and risk mitigation for product life cycle management.
• Coordinate with Scientific Operations, Manufacturing and Quality Control to support development and commercialization.
• Maintain awareness of industry trends and regulatory changes to drive continuous improvement.

Skills

OSD formulation

Supervisory experience

Regulatory guidance

Pharmacokinetics

Biopharmaceutical principles

Project management

Microsoft Office

GMP awareness

Stakeholder management

Job description

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 primary role of the Associate Manager, Formulation is to ensure quality and compliance of Novugen products through effective formulation development of oral solid dosage forms for regulated and semi regulated markets. The incumbent will oversee and contribute to various formulations developed for diverse markets, especially US, EU, ASEAN, and other emerging markets. The incumbent will collaborate with cross functional teams to lead more complex projects within the supervision of Management, contributing to the innovation and growth of Novugen.

Key Responsibilities: -

• Supervise and lead a team of formulation scientists and lab technicians, providing coaching and mentoring to ensure accurate and timely execution of formulation development.
• Oversee literature survey, patent search, online documentation, design, development & execution of developmental batches of new products.
• Supervise team members on preparation of Product Development Plans (PDP), Stability compilations, Product Development Reports in QBD approach, & various other technical documents for regulatory submission.
• Review interpreted analytical results, & grounding decision-based activities for product development with minimum Supervision from upper management.
• Review trial batches of formulation development of tablets, capsules & other solid oral dosage form for global filings following QbD approach.
• Responsible for identifying and addressing the technical trouble shooting for different stages of product transfer and product life cycle management.
• Handling CDO product development, Technology Transfer and addressing the customer requirement with technical data driven process.
• Handling of process driven Technology Transfer for Alternate vendor development & identifying the risk to mitigate to usage of exiting commercial batches.
• Preparation of set of information for specifications, batch records, & other miscellaneous protocols to undertake studies for regulatory submission.
• Review 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.
• Handling of Bio-equivalence studies requirement and driving a discussion with pre-critique, interpretation to interpret 100% success rate in BE.
• Contribution to process development of critical products with technical difficulties for filings, especially due to scale dependent parameters of process.
• Leveraging the technical & practical trouble shooting knowledge to team to avoid the repetition.
• 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.
• Driving a technical discussion, project status, challenges, and progress to Senior Management and stakeholders at all cross-department and leadership meetings as and when required.
• Work closely with Scientific Operations team, Manufacturing and Quality control teams to support product development and commercialization efforts.
• Keep abreast with industry trends, regulations, and technological advancements in formulation methods and techniques, and knowledge transfer to existing team for continuous improvement.
• Any other ad hoc tasks assigned by the management

About you

• Minimum 6-10 years’ related experience from Pharma with OSD formulation experience.
• 2-3 years of supervisory experience.
• Proficient understanding and demonstrated ability in product development for regulated & semi-regulated markets
• Proficient understanding of regulatory guidelines/regulations for successful dossier preparation, submission of Generic products in US, EU and /or global markets
• Proficient 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 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 result.
• Able to effectively deal and maintain relationships with stakeholders