Specialist - Tech Transfer, Formulation (Nasal Spray & Sterile Injectables)

2 days ago

Tuas, Singapore e3ea4ea3-b52a-45a6-9cad-56e43cc104a1 Full time $120,000 - $200,000 per year

Overview

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.


Key Responsibilities

Formulation Development

  • 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.

Process Development & Manufacturing Support

  • 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.

Analytical & Characterization Collaboration

  • 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.

Regulatory & Documentation

  • Prepare technical reports, development summaries, and regulatory-support documents (IND/IMPD sections).
  • Ensure experimental documentation complies with GMP/GDP and internal quality systems.

Client/Project Management

  • 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.

Qualifications

Education & Experience

  • 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.

Technical Skills

  • 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.

Soft Skills

  • 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.

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