Pharma R&D & Formulation Lead

Xepa-Soul Pattinson (Malaysia) Sdn Bhd

Malacca City

On-site

MYR 90,000 - 150,000

Full time

14 days+

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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.