Research and Development Executive

Xepa-Soul Pattinson (Malaysia) Sdn Bhd; Malacca City; On-site; MYR 90,000 - 150,000; Full time

Job summary

Xepa-Soul Pattinson (Malaysia) Sdn Bhd is seeking an Innovation & Development Executive/Senior Executive in Melaka to drive product development from pre-formulation to BE studies. The role involves cross-disciplinary collaboration with pharmacists, chemists, and technical teams to develop oral, topical, and ophthalmic formulations while ensuring GMP, GLP, and ISO compliance.

The successful candidate will lead stability studies, plan BE/DCX activities, prepare dossiers, and support regulatory

Qualifications

• Bachelor's or Master's degree in Pharmacy, Science, or equivalent knowledge in pharmaceutical product development and research.
• Min 4 years of experience, preferably with relevant experiences in a similar industry for pharmaceutical research, development, and technical field.
• Hands-on experience in various formulation and development of Oral, Topical, and Eye/Ear drop dosage forms.
• Basic understanding of QBD and DOE concepts in Pharmaceutical development.
• Capable of preparation of dossier and regulatory documents as per local and international regulatory agencies.
• Preferable working experience handling Bio batches, Scale up, and process validation batches.
• Superior presentation and excellent oral and written communication & influencing skills with computer literacy.

Responsibilities

• To work as an effective member in the I&D Technical Team consisting of pharmacists, chemists and other disciplines.
• To perform product development activities including pre-formulation studies, formulation development, process development, stability studies and prepare documentations leading to dossier submission.
• To prepare study design and report for NPD for review.
• To prepare necessary documentation for the initiation of bioequivalence (BE) study.
• To perform process validation at pilot or commercial scale for new product and reformulation projects.
• To prepare developmental documents for approval of Clinical Trial Exemption (CTX) for bio-batch manufacturing of new product required for clinical study.
• To provide technical support when necessary to process and manufacturing functions to ensure each product consistently meets specifications.
• To prepare stability study protocol and ensure stability study samples are sent for laboratory testing on time.
• To ensure compliance with Good Laboratory Practice and GMP guidelines by regulatory bodies.

Education

Bachelor's or Master's degree in Pharmacy, Science, or equivalent knowledge in pharmaceutical product development and research

Job description

Position: Innovation & Development Executive/Senior Executive

Work base: Cheng, Melaka.

Job Outline:

• To perform Research and Development work leading to formulation development of new products and reformulation projects.
• To perform stability studies of new products and reformulation projects.
• To identify areas for improvement and lead the continuous process improvement projects.
• To liaise with internal clients including Innovation & Development, Technical Services, regulatory & Corporate Affairs, Quality Assurance/ Quality Control and Material/ procurement departments and sometimes jointly meeting with external clients, including raw material vendors for activities relevant to new product development (NPD).
• To support Regulatory Affairs in dossier preparation for new products and reformulation projects.

Duties and Responsibilities:

• To work as an effective member in the I&D Technical Team consisting of pharmacists, chemists and other disciplines.
• To perform product development activities including pre-formulation studies (such as search), formulation development, process development, stability studies and prepare documentations leading to dossier submission.
• To prepare study design and report for NPD for review.
• To prepare necessary documentation for the initiation of bioequivalence (BE) study.
• To perform process validation at pilot or commercial scale for new product and reformulation projects.
• To prepare developmental documents for approval of Clinical Trial Exemption (CTX) for bio-batch manufacturing of new product required for clinical study.
• To provide technical support when necessary to process and manufacturing functions to ensure each product consistently meets specifications (if required).
• To prepare stability study protocol and ensure stability study samples are sent for laboratory testing on time.
• To ensure compliance with "Good Laboratory Practice" at all times in the testing laboratories and in accordance to current Good Manufacturing Practices guidelines set by the Malaysian Drug Control Authority or relevant regulatory bodies in the conduct of formulation developmental work.
• To assist in training and supervise laboratory technicians, assistants and junior Executives in carrying out their duties.
• To perform material planning for necessary products and raw materials for NPD projects.
• To support Technical Services Team during scale up production.
• To support co-ordination of investigational medicine product (IMP) management and handling for BE study.
• To maintain and upkeep project development files and ensure compliance with ISO Management System.
• To perform other jobs related to product quality which may be assigned to you.

Minimum Requirements:

• Bachelor's or Master's degree in Pharmacy, Science, or equivalent knowledge in pharmaceutical product development and research.
• Min 4 years of experience, preferably with relevant experiences in a similar industry for pharmaceutical research, development, and technical field.
• Hands-on experience in various formulation and development of Oral, Topical, and Eye/Ear drop dosage forms.
• Basic understanding of QBD and DOE concepts in Pharmaceutical development.
• Capable of preparation of dossier and regulatory documents as per local and international regulatory agencies.
• Preferable working experience handling Bio batches, Scale up, and process validation batches.
• Superior presentation and excellent oral and written communication & influencing skills with computer literacy.