Innovation & Development Executive

Xepa-Soul Pattinson (Malaysia) Sdn Bhd; Kampung Cheng; On-site; MYR 67,000 - 100,000; Full time

Job summary

Xepa-Soul Pattinson (Malaysia) Sdn Bhd is seeking a Development Executive to drive formulation development and reformulation projects within the R&D team. You will coordinate stability studies, prepare dossiers, and supervise laboratory staff to ensure quality and regulatory readiness across products.

The role involves collaborating with multiple departments, supporting BE studies and scale-up activities, and ensuring compliance with GLP/GMP standards.

Qualifications

• Bachelor's degree in pharmacy, science, technology or engineering.
• Minimum 5 years of experience in production and/or quality control in a manufacturing operation.
• Able to work well in a team environment.

Responsibilities

• Lead formulation development and reformulation projects.
• Coordinate stability study arrangements for new products.
• Identify areas for improvement and drive continuous process improvements.
• Liaise with Innovation & Development, Technical Services, Regulatory & QA/QC, and Procurement.
• Supervise I&D Laboratory Technicians (Formulation – OSD/ Non–OSD).
• Prepare design and reports for NPD; support BE studies and clinical trial-related activities.
• Ensure GMP compliance and timely testing; maintain ISO management system files.

Skills

Teamwork

Education

Bachelor's degree in pharmacy, science, technology or engineering

5+ years of experience in production/quality control in manufacturing

Job description

Toperform Research and Development work leading to formulation development of new productsand reformulation projects.

Tocoordinate and perform stability study arrangement for new products and/or reformulation projects..

Toidentify areas for improvement and lead the continuous process improvement projects.

To liaise with internal clients including Innovation & Development, Technical Services, Regulatory & Corporate Affairs, QA/ QC and Material/ Procurement Departments and sometimes jointly meeting with externalclients, including raw material vendors for activities relevant to new product development (NPD).

To support Regulatory Affairs in dossier preparation.

To supervise I&D Laboratory Technicians (Formulation – OSD/ Non – OSD).

Duties and Responsibilities:

To work as an effective member in the Technical Team consisting of pharmacists, chemists, and other disciplines.

To perform product development activities including pre-formulation studies (such as literature 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.

Toprovide technical service when necessary to process and manufacturing functions to ensure each product consistently meets specifications (if required).

To prepare stability study protocol andensure 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.

• 1. Bachelor's degree in pharmacy, science, technology or engineering; preferably with at least five years of experience in production and/or quality control in a manufacturing operation.
• 4. Able to work well in a team environment.

Pharmaceuticals, Biotechnology & Medical Devices 101-1,000 employees

At Xepa, ideas, people and technology are put together to create trusted, high-quality affordable medicines. We are a pharmaceutical company with a distinct and true commitment - Xepa products help people live healthier, longer and more productive lives.

Founded in 1967 in Singapore, Xepa has grown and evolved at the forefront of the industry. From our modest first years where Xepa Laboratories Pte. Ltd. produced a limited range of pharmaceutical products out of a small flatted factory, we’ve relocated, twice, accommodating expansion to larger manufacturing plants in Malacca, Malaysia. Today, Xepa is the leading manufacturer of off-patent pharmaceuticals in Malaysia.

At Xepa, ideas, people and technology are put together to create trusted, high-quality affordable medicines. We are a pharmaceutical company with a distinct and true commitment - Xepa products help people live healthier, longer and more productive lives.

Founded in 1967 in Singapore, Xepa has grown and evolved at the forefront of the industry. From our modest first years where Xepa Laboratories Pte. Ltd. produced a limited range of pharmaceutical products out of a small flatted factory, we’ve relocated, twice, accommodating expansion to larger manufacturing plants in Malacca, Malaysia. Today, Xepa is the leading manufacturer of off-patent pharmaceuticals in Malaysia.

What can I earn as a Development Executive