Assistant Manager, Formulation Development (Business Improvement)

Assistant Manager, Formulation Development (Business Improvement)

Location: Klang, Selangor
Company: Duopharma (M) Sdn. Bhd.

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Job Summary

We are seeking an experienced and driven professional to lead product quality improvement initiatives, manufacturing process optimisation, and technology transfer projects. This role is responsible for managing formulation trials, evaluating alternative materials, supporting product transfers, and collaborating with cross-functional teams to ensure successful implementation of product improvement and manufacturing initiatives within a GMP-regulated pharmaceutical environment.

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Key Responsibilities

Product & Process Improvement

• Lead formulation trials and product quality improvement projects for existing pharmaceutical products.
• Evaluate alternative and new raw materials to ensure suitability for manufacturing and product performance.
• Review trial results, analyse findings, and provide recommendations to support continuous improvement initiatives.
• Monitor project progress and ensure timely completion of assigned activities.

Technology Transfer & Scale-Up

• Manage pilot batch manufacturing for product variations, site changes, and stability studies.
• Coordinate product scale-up and technology transfer from Research & Development (R&D) to commercial manufacturing sites.
• Support product transfers to new manufacturing facilities while ensuring compliance with quality and regulatory requirements.
• Collaborate with cross-functional teams to ensure smooth implementation of technology transfer activities.

Technical Documentation & Compliance

• Prepare and review technical documents, reports, protocols, and supporting documentation required for Regulatory Affairs (RA), Quality Assurance (QA), and other stakeholders.
• Maintain complete and traceable project documentation in accordance with GMP and Quality Management System (QMS) requirements.
• Author investigation reports, design review documents, trial reports, and technical summaries to support regulatory submissions and product improvement initiatives.

Quality Systems & Laboratory Management

• Ensure compliance with QMS and eQMS requirements, including Change Control (CC), CAPA, Quality Risk Assessment (QRA), FMEA, SOPs, Work Instructions, and internal audits.
• Oversee maintenance and calibration of formulation laboratory equipment.
• Support analytical method development and troubleshooting in collaboration with the Quality Control team.
• Lead procurement and acquisition of laboratory equipment, consumables, and technical resources.

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Requirements

Qualifications

• Bachelor's Degree in Life Sciences, Pharmaceutical Sciences, Pharmacy, Chemistry, or a related discipline.
• A Master's Degree in Pharmaceutical Sciences or Chemistry will be an added advantage.
• Registered Chemist (IKM) or Registered Pharmacist with the Pharmacy Board Malaysia is preferred.

Experience

• Minimum 6 years of experience in the pharmaceutical industry within a GMP-regulated manufacturing environment.
• Experience in formulation development, manufacturing process improvement, analytical method development, technology transfer, or pharmaceutical R&D is highly preferred.
• Experience with Sterile (SVP) and/or Oral Solid Dosage (OSD) products will be an added advantage.

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Technical Skills & Knowledge

• Strong knowledge of pharmaceutical formulation development and manufacturing processes.
• Good understanding of GMP, pharmaceutical quality systems, and regulatory requirements.
• Experience in technology transfer, scale-up, validation, and analytical method development.
• Strong technical writing, report preparation, and project management skills.
• Excellent communication and stakeholder management abilities.

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Leadership Competencies

• Strong analytical and critical thinking skills.
• Proven ability to lead cross-functional projects and deliver results within established timelines.
• Strong planning, organization, and decision-making abilities.
• Ability to perform effectively in a fast-paced and highly regulated environment.
• Excellent leadership, collaboration, and problem-solving skills.

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Why Join Us?

• Lead strategic product improvement and technology transfer projects within one of Malaysia's leading pharmaceutical companies.
• Gain exposure to formulation development, manufacturing optimisation, and regulatory-driven initiatives.
• Collaborate with multidisciplinary teams across R&D, Production, Quality Assurance, Quality Control, Regulatory Affairs, and Technical Services.
• Enjoy opportunities for professional growth and career advancement in a dynamic pharmaceutical manufacturing environment.