Formulation senior specialist

Responsible for supporting the development and optimization of sterile pharmaceutical products, including parenteral, ophthalmic, and inhalation dosage forms, and contributing to scale-up and technology transfer activities in accordance with approved development strategies.

• Design, develop, and optimize sterile formulations for parenteral, ophthalmic, and inhalation products under defined project objectives and technical guidance
  .
• Conduct and document preformulating studies including solubility, pKa, stability, drug-excipient compatibility, and excipient screening as part of development programs
  .
• Perform reverse engineering (DE formulation) studies of RLD formulations, including excipient identification and packaging assessment,
  with findings reported to the formulation lead
  .
• Support optimization of buffer systems, tonicity, pH, preservatives, antioxidants, and surfactants based on predefined formulation strategies
  .
• Evaluate adsorption risks and container-closure compatibility (glass, LDPE, PP, COP, BFS systems) and support extractables and leachables assessments
  .
• Execute and support sterilization approaches (autoclave, sterile filtration, aseptic filling) and assess their impact on product CQAs (assay, impurities, pH, particulates)
  under approved development plans
  .
• Support media fills, aseptic process simulations, and sterility assurance activities in coordination with manufacturing and quality teams
  .
• Support scale-up activities and contribute to the preparation and execution of batch records and technology transfer documentation.
• Participate in process validation activities and assist in troubleshooting formulation and process-related issues.
• Execute filtration studies, including evaluation of pre-filters and sterilizing-grade filters,
  with protocols reviewed and approved by senior staff
  .
• Prepare draft pharmaceutical development and formulation-related sections of the eCTD dossier for review and approval
  .
• Ensure personal adherence to GxP requirements and support compliant laboratory and manufacturing activities.
• Maintain flexibility to support operational requirements, including extended hours or shift work,
  when required
  .

Bachelor's degree in pharmaceutical science (Master degree is an advantage)

5-10 Years

• Strong experience in sterile formulation, BFS technology, sterile packaging systems, stability and degradation pathways.
• QbD, risk management, and process validation.
• Strong scientific and regulatory writing.