Assistant Manager, Formulation Development
Duopharma Biotech Bhd Group of Companies.
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Job summary
Duopharma Biotech Berhad is seeking an experienced professional to lead product quality improvement initiatives, manufacturing process optimisation, and technology transfer projects within a GMP-regulated pharmaceutical environment. You will manage formulation trials, evaluate materials, and collaborate with cross-functional teams to implement product and process improvements.
The role requires a minimum of 6 years in the pharmaceutical industry, with strong knowledge of GMP, quality systems,
Qualifications
- Bachelor's Degree in Life Sciences, Pharmaceutical Sciences, Pharmacy, Chemistry or related discipline.
- Master's Degree in Pharmaceutical Sciences or Chemistry is an added advantage.
- Registered Chemist (IKM) or Registered Pharmacist with the Pharmacy Board Malaysia is preferred.
- 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 is an added advantage.
Responsibilities
- 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.
- Manage pilot batch manufacturing for product variations, site changes, and stability studies.
- Coordinate product scale-up and technology transfer from 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.
- Prepare and review technical documents, reports, protocols, and supporting documentation required for Regulatory Affairs, QA, and other stakeholders.
- Maintain complete and traceable project documentation in accordance with GMP and QMS requirements.
- Author investigation reports, design review documents, trial reports, and technical summaries to support regulatory submissions and product improvement initiatives.
- Ensure compliance with QMS and eQMS requirements, including Change Control, CAPA, 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 Quality Control.
- Lead procurement and acquisition of laboratory equipment, consumables, and technical resources.
Skills
Education
Job description
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Hirer responsiveness Salary match Number of applicants
Your application will include the following questions:
- What's your expected monthly basic salary?
- Which of the following types of qualifications do you have?
Pharmaceuticals, Biotechnology & Medical Devices 101-1,000 employees
Duopharma Biotech Berhad began with the establishment of Duopharma (M) Sdn Bhd in 1978. Incorporated in 2000, we are one of Malaysia’s leading pharmaceutical companies listed on the Bursa Malaysia’s Main Market. We specialise in manufacturing, R&D, and marketing of generic drugs and consumer healthcare products (CHAMPS®, FLAVETTES® & UPHAMOL) as well as biosimilars (ERYSAA®, Basalog One®). As a pioneer in halal pharmaceuticals, we were the 1st to receive JAKIM certification for OTC and prescription products under MS2424:2019. Headquartered in Kuala Lumpur, we operate three GMP-certified plants (Klang, Bangi & Glenmarie) and have a growing presence in Indonesia, the Philippines and Singapore.
Duopharma Biotech Berhad began with the establishment of Duopharma (M) Sdn Bhd in 1978. Incorporated in 2000, we are one of Malaysia’s leading pharmaceutical companies listed on the Bursa Malaysia’s Main Market. We specialise in manufacturing, R&D, and marketing of generic drugs and consumer healthcare products (CHAMPS®, FLAVETTES® & UPHAMOL) as well as biosimilars (ERYSAA®, Basalog One®). As a pioneer in halal pharmaceuticals, we were the 1st to receive JAKIM certification for OTC and prescription products under MS2424:2019. Headquartered in Kuala Lumpur, we operate three GMP-certified plants (Klang, Bangi & Glenmarie) and have a growing presence in Indonesia, the Philippines and Singapore.
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