Pharma R&D Formulation & Development Lead

Xepa-Soul Pattinson (Malaysia) Sdn Bhd; Malacca City; On-site; MYR 60,000 - 100,000; Full time

Job summary

Xepa-Soul Pattinson (Malaysia) Sdn Bhd is seeking a Research & Development professional to lead formulation development for new products and reformulations, and to perform stability studies essential for product lifecycle management.

You will collaborate with I&D, Technical Services, Regulatory, QA/QC and procurement teams, prepare regulatory dossiers, support BE studies, and ensure GLP/GMP adherence while mentoring junior staff.

Qualifications

• Bachelor's or Master's degree in Pharmacy, Science, or equivalent.
• Minimum 4 years in pharmaceutical R&D, product development, or related fields.
• Hands-on formulation development for oral, topical, or ophthalmic products.
• Strong documentation and regulatory dossier preparation skills.

Responsibilities

• Develop formulations and conduct stability studies for new products.
• Lead dossier preparation and regulatory submission activities.
• Coordinate BE studies, process validation, and CTX documentation.
• Train and supervise laboratory staff, ensuring GLP/GMP compliance.

Skills

Formulation development

Stability studies

Dossier preparation

Cross-functional collaboration

Regulatory compliance

Education

Bachelor's or Master's degree in Pharmacy/Science

Tools

GLP/QA/SOP knowledge

DOE/QBD knowledge

Job description

Xepa-Soul Pattinson (Malaysia) Sdn Bhd is seeking a Research & Development professional to lead formulation development for new products and reformulations, and to perform stability studies essential for product lifecycle management.

You will collaborate with I&D, Technical Services, Regulatory, QA/QC and procurement teams, prepare regulatory dossiers, support BE studies, and ensure GLP/GMP adherence while mentoring junior staff.