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A global medical services provider in Singapore is seeking a highly motivated Formulation Development Specialist to lead the development of nasal spray and sterile injectable products. The ideal candidate will possess hands-on formulation expertise and experience within a CDMO environment. Responsibilities include optimizing formulations, supporting manufacturing processes, and ensuring compliance with regulatory standards. This role requires high-level problem-solving skills and the ability to manage multiple projects in a collaborative setting.
Pharmagend Global Medical Services Pte Ltd – Tuas
We are seeking a highly motivated Formulation Development Specialist/Senior Specialist specializing in nasal spray and sterile injectable drug product development. The successful candidate will support client-sponsored projects by developing robust and scalable formulations, executing laboratory studies, leading technical transfers, and contributing to regulatory documentation. This role requires hands‑on formulation expertise, strong problem‑solving skills, and the ability to operate effectively in a fast‑paced CDMO environment.
Develop and optimize formulations for nasal sprays, including solution‑ and suspension‑based systems, preservative‑free formulations, and particle size characterization.
Develop formulations for sterile injectables, including small molecules, peptides, biologics, aqueous solutions, lyophilized products, emulsions, and suspensions.
Conduct excipient compatibility studies, solubility screening, and formulation robustness assessments.
Design and execute DoE, scale‑up studies, and process optimization experiments.
Support manufacturing at pilot and GMP scale, including sterile/aseptic operations (filter sterilization, aseptic filling, lyophilization).
Prepare batch records, process descriptions, and technical packages for internal and client use.
Work closely with analytical teams for method development/qualification, stability study design, and product characterization (e.g., delivered dose uniformity, droplet/particle size distribution, osmolality, pH, viscosity, sterility).
Interpret data and provide scientific justification for formulation and process decisions.
Prepare technical reports, development summaries, and regulatory‑support documents (IND/IMPD sections).
Ensure experimental documentation complies with GMP/GDP and internal quality systems.
Serve as a technical point‑of‑contact in CDMO client projects.
Communicate project progress, risks, and mitigation strategies to internal stakeholders and clients.
Support project planning, timelines, and resource estimates.
Master’s or PhD in Pharmaceutical Sciences, Chemical Engineering, Biotechnology, or related field.
2–8 years (adjustable based on level) of hands‑on formulation experience.
Prior experience in nasal spray or sterile injectable product development in a CDMO or pharma environment is highly preferred.
Strong knowledge of nasal spray device/formulation interfaces, including pump systems and performance testing.
Understanding of sterile formulation principles, aseptic processing, filtration, lyophilization, and container–closure systems (vials, PFS, cartridges).
Familiarity with QbD, DoE, and risk assessment tools (FMEA, Ishikawa).
Knowledge of regulatory expectations (FDA, EMA, ICH) for sterile and nasal drug products.
Strong problem‑solving and scientific reasoning skills.
Ability to manage multiple projects in a fast‑paced CDMO environment.
Excellent verbal and written communication, including client‑facing interactions.
Team‑oriented, collaborative, and detail‑oriented.