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A pharmaceutical development company in Singapore is seeking a motivated Formulation Development Specialist/Senior Specialist with expertise in topical cream and semi-solid dosage forms. You will lead multiple development projects, collaborating closely with clients and ensuring compliance with regulatory standards. The ideal candidate has a Master’s or PhD in a relevant field and 3–8 years of experience in formulation development. This role thrives in a fast-paced environment working with diverse projects.
Develop and optimize cream, ointment, and gel formulations for client projects across early-stage, late-stage, and lifecycle programs.
Conduct pre-formulation studies including API–excipient compatibility, solubility profiling, rheology evaluation, and prototype screening.
Use QbD and DoE methodologies to identify critical material attributes (CMAs) and critical process parameters (CPPs).
Assess API impact on emulsion stability, viscosity, microstructure, and overall product performance.
Define product CQAs (viscosity/rheology profile, pH, globule size, release rate, etc.) for semi-solid dosage forms.
Partner with Analytical Development to establish or refine analytical methods (e.g., HPLC assays, IVRT/IVPT).
Interpret physical and chemical stability data to guide formulation optimization and risk mitigation strategies.
Develop robust, scalable manufacturing processes (emulsification, homogenization, heating/cooling cycles, mixing strategies).
Support pilot-scale batches, engineering runs, and GMP clinical/commercial batch execution.
Lead or support technical transfer activities to internal or client manufacturing sites.
Troubleshoot formulation or process deviations in collaboration with Manufacturing and Quality.
Serve as a scientific point-of-contact for clients, providing technical updates, data interpretation, and strategic recommendations.
Prepare and present development plans, timelines, and deliverables in client meetings.
Ensure project execution aligns with client expectations, regulatory requirements, and CDMO quality standards.
Prepare formulation development reports (FDR), technical protocols, batch records, and process descriptions.
Contribute to CMC documentation for client regulatory filings (IND, NDA, ANDA, IMPD).
Maintain clear, audit-ready documentation in compliance with GMP and CDMO quality systems.
Master’s or PhD in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related discipline.
Bachelor’s degree with strong relevant experience may also be considered.
3–8 years’ experience in semisolid formulation development, preferably within a CDMO or fast-paced development environment.
Demonstrated expertise in emulsions (O/W, W/O), surfactants, rheology modifiers, preservatives, and skin delivery technologies.
Hands‑on experience with pilot-scale equipment, process scale‑up, and technology transfer.
Knowledge of IVRT/IVPT methods and topical regulatory expectations (USP, ICH, FDA, EMA) is an advantage.
Proficiency with rheology tools, viscometers, globule size analyzers, homogenizers, and other semi-solid processing equipment.
Strong analytical and problem‑solving skills; ability to interpret complex formulation and process data.
Excellent communication and client‑facing skills.
Able to manage multiple concurrent projects and deliver results on accelerated CDMO timelines.
Strong technical writing and documentation abilities.
Pharmagend Global Medical Services Pte Ltd – Tuas
We are seeking a motivated Formulation Development Specialist/Senior Specialist with expertise in topical cream and semi-solid dosage forms to join our CDMO pharmaceutical development team. In this client-facing role, you will lead and support multiple development projects, from pre-formulation through scale-up and technology transfer to GMP manufacturing. The ideal candidate will thrive in a fast-paced environment working with diverse molecules, formulations, and client requirements.